Irritable Bowel SyndromeNCT06687720
A Clinical Study to Determine the Safety and Efficacy of An Oral Probiotic Supplementation in the Management of Irritable Bowel Syndrome With Protein Digestion.
A study testing MetBroma in people with Irritable Bowel Syndrome, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
This is an open-label, two-arm, prospective, interventional, in-use safety and efficacy study of an oral probiotic supplementation in adult subjects having irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- MetBroma
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteIndia
- Study dates
- 30 Nov 2024to 30 Nov 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is an adult male or female aged between 18 to 60 years old.
- Clinically diagnosed with irritable bowel syndrome (IBS) based on Rome IV criteria: Abdominal pain at least 4 days per month - over at least 2 months - associated with one or more of the following:
- Related to defecation ii. A change in frequency of stool iii. A change in form (appearance) of stool iv. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
- The subject is having refrigerator at their home for storage of test treatment.
- The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.
- The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.
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- The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
- If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
- Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
- Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration.
Who cannot join
- The subject has a history of diagnosis of either hypertension, diabetes, or liver disease.
- The subject has any other significant medical condition that could interfere with the study or pose a risk to the participant.
- The subject has used medications that could influence the study outcomes, such as antibiotics, immunosuppressive drugs, and probiotics or prebiotics supplements within the last 4 weeks.
- The subject works in frequent night shifts (working night shifts at least 3 times per week), and refuses to change the lifestyle.
- The subject has a history of alcohol abuse.
- The subject is either pregnant, lactating, or plans on conceiving during the course of the study.
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- The subject has participated in other clinical studies or received any investigational agent in the previous 30 days.
- The subject has other significant gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, celiac disease).
- The subject has any condition that, in the investigator's judgment, would compromise the subject's safety or study integrity.
- The subject has abnormal baseline Haemoglobin (Hb), Complete Blood Count (CBC), Urine Routine/Microscopy (R/M), or Stool Routine/Microscopy (R/M) results that suggest a different pathology than irritable bowel syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Management of Irritable Bowel Syndrome: A Randomized, Open Label, Placebo-Arm, Comparative, Interventional, Proof-of-Science Study
This is an open-label, two-arm, prospective, interventional, in-use safety and efficacy study of an oral probiotic supplementation in adult subjects having irritable bowel syndrome.
Read the detailed description
A total of the up to 18 adults aged between 18 and 60 years, with irritable bowel syndrome will be enrolled to ensure 16 subjects complete the study.
Subjectsshall be instructed to visit the facility for the following scheduled visits:
- Visit 01 [Within 30 days]: Screening, Blood Parameter Assessment.
- Visit 02 [Day 01]: Enrolment, Evaluations, Treatment Dispensing.
- Visit 03 [Day 15 (±2 days)]: Telephonic follow-up.
- Visit 04 [Day 30 (±2 days)]: Treatment End, Final Evaluations.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- MetBroma
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetBromaOther
Mode of Usage: Take one slow-release capsule twice a day, after meal Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day
| Study group | Role | What they receive |
|---|---|---|
| MetBroma | Experimental | Active Ingredients: Bromelain Mode of Usage: Take one slow-release capsule twice a day, after meal with water Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day Receives: Other: MetBroma |
| Placebo | Placebo comparator | Mode of Usage: Take one slow-release capsule twice a day, after meal with water Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day Receives: Other: MetBroma |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Albumin/Globulin ratio
Evaluate the effect of the test treatment in terms of change in Albumin/Globulin ratio
Measured: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
change in total serum protein
Evaluate the effect of the test treatment in terms of change in total serum protein
Measured: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
change in prealbumin levels
Evaluate the effect of the test treatment in terms of change in prealbumin levels.
Measured: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
Change in the lifestyle using the Scoring and Gradation
Assessment of the effectiveness of the test treatment in terms of change in the lifestyle using the Scoring and Gradation.
Severely disturbed lifestyle- 76%-100% Marked disturbed lifestyle-51%-75% Moderately disturbed lifestyle -25%-50% Mild disturbed lifestyle<25
Measured: Day 01 (before administration) for baseline, and post-dose on Day 30.
Scoring and Gradation of symptoms of irritable bowel syndrome
Evaluate of the effect of test treatment using Scoring and Gradation of symptoms of irritable bowel syndrome.
Complete remission-76%-100% Marked improvement-51%-75% Mild improvement-25%-50% Unchanged<25%
Measured: Day 01 (before administration) for baseline, and post-dose on Day 30.
Secondary outcomes (5)
Performance of safety laboratory tests including Complete Blood Count (CBC)
Evaluate the safety of test treatment through the performance of safety laboratory tests including Complete Blood Count (CBC)
Measured: on Day 30
Performance of safety laboratory tests including Biochemical tests
Evaluate the safety of test treatment through the performance of safety laboratory tests including Biochemical tests
Measured: on Day 30
Performance of safety laboratory tests including Urinalysis
Evaluate the safety of test treatment through the performance of safety laboratory tests including Urinalysis
Measured: on Day 30
Assessment of the effectiveness of the test treatment in terms of change in CRP levels
CRP will be evaluated by Lab Parameters
Measured: on Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).
Assessment of the effectiveness of the test treatment in terms of change in IL-6 levels
IL-6 will be evaluated by Lab Parameters
Measured: On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start30 Nov 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT06687720
- Sponsor's protocol ID
- NB240026-MB
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2024
- Last updated
- 31 Jul 2026
- 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Management of Irritable Bowel Syndrome: A Randomized, Open Label, Placebo-Arm, Comparative, Interventional, Proof-of-Science Study
- ClinicalTrials.gov ID
- NCT06687720
- Acronym / sponsor ID
- NB240026-MB
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Meteoric Biopharmaceuticals Pvt. Ltd.
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 14 Nov 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 an open-label, two-arm, prospective, interventional, in-use safety and efficacy study of an oral probiotic supplementation in adult subjects having irritable bowel syndrome.
Detailed description
A total of the up to 18 adults aged between 18 and 60 years, with irritable bowel syndrome will be enrolled to ensure 16 subjects complete the study.
Subjectsshall be instructed to visit the facility for the following scheduled visits:
- Visit 01 [Within 30 days]: Screening, Blood Parameter Assessment.
- Visit 02 [Day 01]: Enrolment, Evaluations, Treatment Dispensing.
- Visit 03 [Day 15 (±2 days)]: Telephonic follow-up.
- Visit 04 [Day 30 (±2 days)]: Treatment End, Final Evaluations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MetBroma | Experimental | Other: MetBromaActive Ingredients: Bromelain Mode of Usage: Take one slow-release capsule twice a day, after meal with water Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day |
| Placebo | Placebo comparator | Other: MetBromaMode of Usage: Take one slow-release capsule twice a day, after meal with water Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subject is an adult male or female aged between 18 to 60 years old.
- Clinically diagnosed with irritable bowel syndrome (IBS) based on Rome IV criteria: Abdominal pain at least 4 days per month - over at least 2 months - associated with one or more of the following:
- The subject is having refrigerator at their home for storage of test treatment.
- The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.
- The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.
Key exclusion criteria (10 listed)
- The subject has a history of diagnosis of either hypertension, diabetes, or liver disease.
- The subject has any other significant medical condition that could interfere with the study or pose a risk to the participant.
- The subject has used medications that could influence the study outcomes, such as antibiotics, immunosuppressive drugs, and probiotics or prebiotics supplements within the last 4 weeks.
- The subject works in frequent night shifts (working night shifts at least 3 times per week), and refuses to change the lifestyle.
- The subject has a history of alcohol abuse.
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 |
|---|---|---|
| MetBromaMode of Usage: Take one slow-release capsule twice a day, after meal Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day | Other | MetBroma, Placebo |
Primary outcome
change in Albumin/Globulin ratio
Time frame: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
Evaluate the effect of the test treatment in terms of change in Albumin/Globulin ratio
change in total serum protein
Time frame: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
Evaluate the effect of the test treatment in terms of change in total serum protein
change in prealbumin levels
Time frame: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
Evaluate the effect of the test treatment in terms of change in prealbumin levels.
Change in the lifestyle using the Scoring and Gradation
Time frame: Day 01 (before administration) for baseline, and post-dose on Day 30.
Assessment of the effectiveness of the test treatment in terms of change in the lifestyle using the Scoring and Gradation. Severely disturbed lifestyle- 76%-100% Marked disturbed lifestyle-51%-75% Moderately disturbed lifestyle -25%-50% Mild disturbed lifestyle<25
Scoring and Gradation of symptoms of irritable bowel syndrome
Time frame: Day 01 (before administration) for baseline, and post-dose on Day 30.
Evaluate of the effect of test treatment using Scoring and Gradation of symptoms of irritable bowel syndrome. Complete remission-76%-100% Marked improvement-51%-75% Mild improvement-25%-50% Unchanged<25%
5 secondary outcomes
Performance of safety laboratory tests including Complete Blood Count (CBC)
Time frame: on Day 30
Performance of safety laboratory tests including Biochemical tests
Time frame: on Day 30
Performance of safety laboratory tests including Urinalysis
Time frame: on Day 30
Assessment of the effectiveness of the test treatment in terms of change in CRP levels
Time frame: on Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).
Assessment of the effectiveness of the test treatment in terms of change in IL-6 levels
Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).
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 31 Jul 2026.
- 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 MetBroma in people with Irritable Bowel Syndrome, 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 10 inclusion and 10 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 31 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
change in Albumin/Globulin ratio (time frame: Baseline before and 6-8 hours post-dose on Day 01 and Day 30). The study lists 5 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 31 Jul 2026.