Gut DysbiosisNCT06572358
A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects Having Symptoms of Gut Dysbiosis (Heart Burn, Bloating, Constipation and Gut Immunity).
A study testing MetProUltima in people with Gut Dysbiosis, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
This is prospective, open-label, single-arm, proof of science, clinical safety and efficacy study of MetProUltima in healthy adult human subjects having symptoms of Gut Dysbiosis (heart burn, bloating, constipation). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Dysbiosis
- What is being tested?
- MetProUltima
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIndia
- Study dates
- 22 Oct 2024to 7 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 to 65 years (both inclusive) at the time of consent.
- Sex: Healthy males and healthy non-pregnant/non-lactating females.
- Females of childbearing potential must have a self-reported negative pregnancy test.
- Subject should have refrigerator at their home for storage of test product.
- Subjects having history of falling sick frequently in two months.
- Subjects having gut dysbiosis with either of these three symptoms which includes burning sensation, bloating, nausea, altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea etc.
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- If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
- Subjects are willing to give written informed consent and are willing to come for regular follow-up.
- Subjects who commit not to use other probiotics, symbiotic, prebiotics, medicated treatments or food having high probiotics other than the test product for the entire duration of the study.
- Subject who has not participated in a similar investigation in the past three months.
- Willing to use test product throughout the study period.
Who cannot join
- Subject with suspected or proved organic causes of constipation, such as Hirschsprung's disease, hypothyroidism, or structural anomalies of the anal canal.
- Subject with present condition of allergic response to any probiotic product.
- Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
- Subjects with any major diseases of the cardiovascular, renal, hepatic, gastrointestinal, pulmonary or endocrine systems.
- History of alcohol or drug addiction.
- Subjects with a history of major gastrointestinal complications (i.e. Crohn's disease, ulcer, cancer, ulcerative colitis).
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- Subjects who have self-reported immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis).
- Pregnant or breastfeeding or planning to become pregnant during the study period.
- Subjects participating in other similar product or therapeutic trials within the last four weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-label, Single-arm, Proof of Science, Clinical Safety and Efficacy Study of MetProUltima in Healthy Adult Human Subjects Having Symptoms of Gut Dysbiosis (Heart Burn, Bloating, Constipation, and Gut Immunity).
This is prospective, open-label, single-arm, proof of science, clinical safety and efficacy study of MetProUltima in healthy adult human subjects having symptoms of Gut Dysbiosis (heart burn, bloating, constipation).
Read the detailed description
A total of up to 14 subjects will be enrolled to get 12 evaluable subjects complete the study.
The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Subjects having symptoms of gut dysbiosis like burning sensation, bloating nausea and altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea will be enrolled in the study. The subjects will be instructed to visit the facility as per the below visits.
Visit 01 (Day -01): Screening, Blood Sample Collection Visit 02 (Day 01): Enrolment, Faecal Sample Collection, Test Product Dispensing Visit 03 (Day 45 ±2 Days): Treatment usage period, Evaluations Visit 04 (Day 90 ±2 Days): Treatment usage period, Evaluations and End of study.
- Conditions
- Gut Dysbiosis
- Being tested
- MetProUltima
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetProUltimaOther
Test product Name: MetProUltima Marketed By| Manufactured By: Meteoric Biopharmaceuticals Private Limited Mode of Usage: Take one capsule after each meal, twice daily. Frequency: Twice a Day Route of Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| MetProUltima | Experimental | Test product Name: MetProUltima Marketed By| Manufactured By: Meteoric Biopharmaceuticals Private Limited Mode of Usage: Take one capsule after each meal, twice daily. Frequency: Twice a Day Route of Administration: Oral Receives: Other: MetProUltima |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in stool consistency based on the Bristol Stool Criteria
To evaluate the effectiveness of the test product in terms of change in stool based on the Bristol Stool Criteria categorizes stools into one of seven stool types ranging from type 1 (hard lumps) to type 7 (watery diarrhoea).
Measured: Baseline before usage of the test product on Day 01, and after usage of the test product on Day 45 and on Day 90
Change in faecal microbiota using 16s Metagenome sequencing
To evaluate the effectiveness of test product in terms of change in faecal microbiota using 16s Metagenome sequencing
Measured: Baseline at Day 1, and on Day 90.
Abbreviated physical examinations in terms of frequency of sensation of defecation
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of frequency of sensation of defecation according to a 5-point Likert scale, with a score ranging from 0 (no symptoms) to 20 (very severe symptoms
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of bloating
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of bloating in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of nausea
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of nausea where scoring determined no nausea=0, mild nausea=1-2, moderate nausea 3-6, and severe nausea7-9
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of altered bowel habit.
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of altered bowel habit in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of digestion issues
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of digestion issues in which scoring done on yes or no
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of aching joints
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of aching joints in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of chronic fatigue
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of chronic fatigue in which scoring done as less than 1 week=1, less than1 month=2, less than 6 months=3 and more than 6 months=4
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Frequency of bowel movements
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Frequency of bowel movements in which scoring done 1-2 times per 1-2 days=1 and less than once per month=4
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation in which scoring done never=0 and always=4
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt in which scoring done Less than 5=0 and More than 30=4
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours in which scoring done never=0 and More than 9 =4
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort in which scoring done never=0 and always =4
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Pain: abdominal pain
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Pain: abdominal pain in which scoring done never=0 and always =4
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for Assistance: type of assistance
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Assistance: type of assistance in which scoring done without assistance=0 and Digital assistance or enema =2
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of constipation for History: duration of constipation (years)
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for History: duration of constipation (years) in which scoring done 0=0 and more than 20 =4
Measured: Baseline Day 1, Day 45 and on Day 90
Abbreviated physical examinations in terms of diarrhoea
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of diarrhoeawhere score, severe diarrhea - having more than 10 loose, watery stools in a single day (24 hours). Moderate diarrhea -having more than a few but not more than 10 diarrhea stools in a day and Mild
Measured: Baseline Day 1, Day 45 and on Day 90
Secondary outcomes (43)
Effectiveness by biomarkers like CRP (C reactive protein).
To assess the effectiveness of the test product by Biomarkers like CRP(C reactive protein)
Measured: baseline Day 01 and after usage of the test product on Day 90.
Effectiveness by biomarkers like IL-6 (Interleukin-6).
To assess the effectiveness of the test product by Biomarkers IL-6 (Interleukin-6)
Measured: baseline Day 01 and after usage of the test product on Day 90.
Effectiveness of the test product in terms of subject perception questionnaire where scoring by licert scale where 1 = not at all and 5=Extremely
To assess the effectiveness of the test product in terms of subject perception questionnaire
Measured: Baseline before usage of the test product on Day 01 and after usage of the test product, on Day 45 and on Day 90
change in lab parameters-Hemoglobin
To assess the effectiveness of the test product in terms of change in lab parameters Hemoglobin
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Hematocrit
To assess the effectiveness of the test product in terms of change in lab parameters Hematocrit
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-RBC Counts (Red Blood Corpuscle)
To assess the effectiveness of the test product in terms of change in lab parameters RBC Counts (Red Blood Corpuscle)
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-MCV (Mean corpuscular volume)
To assess the effectiveness of the test product in terms of change in lab parameters MCV (Mean corpuscular volume)
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-MCH (mean corpuscular hemoglobin)
To assess the effectiveness of the test product in terms of change in lab parameters MCH (mean corpuscular hemoglobin)
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-MCHC (Mean corpuscular hemoglobin concentration)
To assess the effectiveness of the test product in terms of change in lab parameters MCHC (Mean corpuscular hemoglobin concentration)
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-RDW (Red cell distribution width)
To assess the effectiveness of the test product in terms of change in lab parameters RDW (Red cell distribution width)
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-WBC Counts (White blood cells)
To assess the effectiveness of the test product in terms of change in lab parameters WBC Counts (White blood cells)
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Neutrophils
To assess the effectiveness of the test product in terms of change in lab parameters Neutrophils
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Lymphocytes
To assess the effectiveness of the test product in terms of change in lab parameters Lymphocytes
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Eosinophils
To assess the effectiveness of the test product in terms of change in lab parameters Eosinophils
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Monocytes
To assess the effectiveness of the test product in terms of change in lab parameters Monocytes
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Basophils
To assess the effectiveness of the test product in terms of change in lab parameters Basophils
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-RBC morphology
To assess the effectiveness of the test product in terms of change in lab parameters RBC morphology
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Platelet Count
To assess the effectiveness of the test product in terms of change in lab parameters Platelet Count
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Random Blood Sugar
To assess the effectiveness of the test product in terms of change in lab parameters Random Blood Sugar
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Total Serum Cholesterol
To assess the effectiveness of the test product in terms of change in lab parameters Total Serum Cholesterol
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Triglyceride
To assess the effectiveness of the test product in terms of change in lab parameters Triglyceride
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-HDL (High-density lipoprotein cholesterol)
To assess the effectiveness of the test product in terms of change in lab parameters HDL (High-density lipoprotein cholesterol)
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-LDL (Low-density lipoprotein)
To assess the effectiveness of the test product in terms of change in lab parameters LDL (Low-density lipoprotein)
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Serum Creatinine
To assess the effectiveness of the test product in terms of change in lab parameters Serum Creatinine
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Color
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Color
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Transparency
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Transparency
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Specific Gravity
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Specific Gravity
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -pH
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -pH
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Albumin
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Albumin
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Glucose
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Glucose
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Bile Salts
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Bile Salts
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Bile Pigments
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Bile Pigments
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Bilirubin
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Bilirubin
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Urobilinogen
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Urobilinogen
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Ketone
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Ketone
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Nitrite
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Nitrite
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -RBCs (Red Blood Corpuscle)
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -RBCs (Red Blood Corpuscle)
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Leucocyte
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Leucocyte
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -WBC (White blood cell)
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -WBC (White blood cell)
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Epithelial Cell
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Epithelial Cell
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Casts
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Casts
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Crystals
To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Crystals
Measured: Baseline on Day -01 and after usage of the test product on Day 90.
Adverse events
Safety will be determined by treatment-emergent adverse events such as allergies, diarrhoea, bloating, nausea, headache assessed by the study investigator.
Measured: Baseline Day 1, Day 45 and on Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start22 Oct 2024
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut DysbiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Open-label, Single-arm, Proof of science
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Meteoric Biopharmaceuticals Pvt. Ltd.
- Responsible party
- Sponsor
- Investigators
- Dr. Nayan K Patel, Principal investigator, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572358
- Sponsor's protocol ID
- NB240019-MB
- Status last verified
- Feb 2025
- First submitted
- 11 Aug 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Single-arm, Proof of Science, Clinical Safety and Efficacy Study of MetProUltima in Healthy Adult Human Subjects Having Symptoms of Gut Dysbiosis (Heart Burn, Bloating, Constipation, and Gut Immunity).
- ClinicalTrials.gov ID
- NCT06572358
- Acronym / sponsor ID
- NB240019-MB
- Conditions
- Gut Dysbiosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Meteoric Biopharmaceuticals Pvt. Ltd.
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is prospective, open-label, single-arm, proof of science, clinical safety and efficacy study of MetProUltima in healthy adult human subjects having symptoms of Gut Dysbiosis (heart burn, bloating, constipation).
Detailed description
A total of up to 14 subjects will be enrolled to get 12 evaluable subjects complete the study.
The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Subjects having symptoms of gut dysbiosis like burning sensation, bloating nausea and altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea will be enrolled in the study. The subjects will be instructed to visit the facility as per the below visits.
Visit 01 (Day -01): Screening, Blood Sample Collection Visit 02 (Day 01): Enrolment, Faecal Sample Collection, Test Product Dispensing Visit 03 (Day 45 ±2 Days): Treatment usage period, Evaluations Visit 04 (Day 90 ±2 Days): Treatment usage period, Evaluations and End of study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Open-label, Single-arm, Proof of science
| Arm | Type | Receives |
|---|---|---|
| MetProUltima | Experimental | Other: MetProUltimaTest product Name: MetProUltima Marketed By| Manufactured By: Meteoric Biopharmaceuticals Private Limited Mode of Usage: Take one capsule after each meal, twice daily. Frequency: Twice a Day Route of Administration: Oral |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: 18 to 65 years (both inclusive) at the time of consent.
- Sex: Healthy males and healthy non-pregnant/non-lactating females.
- Females of childbearing potential must have a self-reported negative pregnancy test.
- Subject should have refrigerator at their home for storage of test product.
- Subjects having history of falling sick frequently in two months.
Key exclusion criteria (9 listed)
- Subject with suspected or proved organic causes of constipation, such as Hirschsprung's disease, hypothyroidism, or structural anomalies of the anal canal.
- Subject with present condition of allergic response to any probiotic product.
- Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
- Subjects with any major diseases of the cardiovascular, renal, hepatic, gastrointestinal, pulmonary or endocrine systems.
- History of alcohol or drug addiction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetProUltimaTest product Name: MetProUltima Marketed By| Manufactured By: Meteoric Biopharmaceuticals Private Limited Mode of Usage: Take one capsule after each meal, twice daily. Frequency: Twice a Day Route of Administration: Oral | Other | MetProUltima |
Primary outcome
Changes in stool consistency based on the Bristol Stool Criteria
Time frame: Baseline before usage of the test product on Day 01, and after usage of the test product on Day 45 and on Day 90
To evaluate the effectiveness of the test product in terms of change in stool based on the Bristol Stool Criteria categorizes stools into one of seven stool types ranging from type 1 (hard lumps) to type 7 (watery diarrhoea).
Change in faecal microbiota using 16s Metagenome sequencing
Time frame: Baseline at Day 1, and on Day 90.
To evaluate the effectiveness of test product in terms of change in faecal microbiota using 16s Metagenome sequencing
Abbreviated physical examinations in terms of frequency of sensation of defecation
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of frequency of sensation of defecation according to a 5-point Likert scale, with a score ranging from 0 (no symptoms) to 20 (very severe symptoms
Abbreviated physical examinations in terms of bloating
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of bloating in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4
Abbreviated physical examinations in terms of nausea
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of nausea where scoring determined no nausea=0, mild nausea=1-2, moderate nausea 3-6, and severe nausea7-9
Abbreviated physical examinations in terms of altered bowel habit.
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of altered bowel habit in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4
Abbreviated physical examinations in terms of digestion issues
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of digestion issues in which scoring done on yes or no
Abbreviated physical examinations in terms of aching joints
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of aching joints in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4
Abbreviated physical examinations in terms of chronic fatigue
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of chronic fatigue in which scoring done as less than 1 week=1, less than1 month=2, less than 6 months=3 and more than 6 months=4
Abbreviated physical examinations in terms of constipation for Frequency of bowel movements
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Frequency of bowel movements in which scoring done 1-2 times per 1-2 days=1 and less than once per month=4
Abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation in which scoring done never=0 and always=4
Abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt in which scoring done Less than 5=0 and More than 30=4
Abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours in which scoring done never=0 and More than 9 =4
Abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort in which scoring done never=0 and always =4
Abbreviated physical examinations in terms of constipation for Pain: abdominal pain
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Pain: abdominal pain in which scoring done never=0 and always =4
Abbreviated physical examinations in terms of constipation for Assistance: type of assistance
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Assistance: type of assistance in which scoring done without assistance=0 and Digital assistance or enema =2
Abbreviated physical examinations in terms of constipation for History: duration of constipation (years)
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for History: duration of constipation (years) in which scoring done 0=0 and more than 20 =4
Abbreviated physical examinations in terms of diarrhoea
Time frame: Baseline Day 1, Day 45 and on Day 90
To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of diarrhoeawhere score, severe diarrhea - having more than 10 loose, watery stools in a single day (24 hours). Moderate diarrhea -having more than a few but not more than 10 diarrhea stools in a day and Mild
43 secondary outcomes
Effectiveness by biomarkers like CRP (C reactive protein).
Time frame: baseline Day 01 and after usage of the test product on Day 90.
Effectiveness by biomarkers like IL-6 (Interleukin-6).
Time frame: baseline Day 01 and after usage of the test product on Day 90.
Effectiveness of the test product in terms of subject perception questionnaire where scoring by licert scale where 1 = not at all and 5=Extremely
Time frame: Baseline before usage of the test product on Day 01 and after usage of the test product, on Day 45 and on Day 90
change in lab parameters-Hemoglobin
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Hematocrit
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-RBC Counts (Red Blood Corpuscle)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-MCV (Mean corpuscular volume)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-MCH (mean corpuscular hemoglobin)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-MCHC (Mean corpuscular hemoglobin concentration)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-RDW (Red cell distribution width)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-WBC Counts (White blood cells)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Neutrophils
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Lymphocytes
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Eosinophils
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Monocytes
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Basophils
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-RBC morphology
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Platelet Count
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Random Blood Sugar
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Total Serum Cholesterol
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Triglyceride
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-HDL (High-density lipoprotein cholesterol)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-LDL (Low-density lipoprotein)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Serum Creatinine
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Color
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Transparency
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Specific Gravity
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -pH
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Albumin
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Glucose
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Bile Salts
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Bile Pigments
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Bilirubin
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Urobilinogen
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Ketone
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Nitrite
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -RBCs (Red Blood Corpuscle)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Leucocyte
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -WBC (White blood cell)
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
change in Urine Routine and Microscopy -Epithelial Cell
Time frame: Baseline on Day -01 and after usage of the test product on Day 90.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Nayan K Patel principal investigator
NovoBliss Research Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MetProUltima in people with Gut Dysbiosis, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in stool consistency based on the Bristol Stool Criteria (time frame: Baseline before usage of the test product on Day 01, and after usage of the test product on Day 45 and on Day 90). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.