Diarrhea-Predominant Irritable Bowel SyndromeNCT06346847
Study to Assess Effects of Postbiotic vs Placebo in Participants With Diarrhea-predominant IBS
A study testing Postbiotic in people with Diarrhea-Predominant Irritable Bowel Syndrome, run by A-Mansia Biotech S.A. at 23 sites in India.
Trial summary
The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study that assesses the effect of postbioc on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome (IBS-D). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea-Predominant Irritable Bowel Syndrome
- What is being tested?
- Postbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 23 sitesIndia
- Study dates
- 18 Jul 2024to 13 Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women from 18 to 55 years old.
- Individuals diagnosed for IBS within the last two years, and meets Rome-IV criteria for IBS: recurrent abdominal pain on average ≥1 day/week in ≥3 months prior to study (with symptom onset ≥6 months prior to study), associated with ≥2 of the following criteria:
- Related to defecation
- Associated with a change in frequency of stool
- Associated with a change in form (appearance) of stool.
- Has IBS-D, i.e., more than ¼ (25%) of bowel movements with Bristol stool types 6 or 7 and less than ¼ (25%) of bowel movements with Bristol stool types 1 or 2); in other words, put practically and as per FDA: at least 2 days per week with at least one stool that has a consistency of Type 6 or Type 7 BSS.
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- Has an IBS-SSS of at least 175 points at screening.
- Individuals either with abdominal pain or discomfort (≥ 6 to ≤ 10 on an 11-point scale).
- Has had no prior line of conventional intervention for IBS or dietary change in the last 4 weeks before screening (e.g., low FODMAP, soluble fibers, antispasmodics, laxatives, obstipants, serotonin agonist/antagonist) i.e., recently diagnosed individuals
- Individuals' agreement to comply with study procedures, in particular:
- to take IP as recommended,
- to avoid the use of other products which may influence the gastrointestinal (GI) complaints, mental symptoms or commensal flora during the study as defined in Section 6.8 Prior and Concomitant Therapy,
- to keep the habitual dietary habits, level of physical activity as well as the level of caffeine or nicotine (if any),
- to complete the individual's diary and study questionnaires.
- Women of childbearing potential:
- commitment to use contraception methods,
- Negative pregnancy testing (beta human chorionic gonadotropin test in urine).
- Readiness not to participate in another clinical study during this study.
- Participation is based upon written informed consent by the individual following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
Who cannot join
- Known allergy or hypersensitivity to the components of the investigational product.
- Smokers
- Lactose or fructose intolerance.
- Individuals with uncontrolled hypertension as assessed by systolic blood pressure ≥ to 160 mmHg and diastolic blood pressure ≥ to 100mmHg.
- History of diverticulitis, intestinal obstruction, stricture, toxic megacolon, GI (gastro-intestinal) perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g., aorto-iliac disease) or recent unexplained GI bleeding within 3 months prior to screening.
- History of malignancy within 3 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
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- History and/or presence of acute or chronic significant GI disease or digestion/absorption disorders (e.g., inflammatory bowel disease, coeliac disease, Clostridium difficile colitis, pancreatitis, disorders in digestive tract motility, gluten enteropathy, etc.)
- Major gastric, hepatic, biliary, pancreas or intestinal surgery within the last 6 months prior to screening or planned during the study (appendectomy, hemorrhoidectomy, or polypectomy allowed as long as occurred \> 3 months prior to study screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred \> 3 months prior to screening).
- Clinically significant findings in colonoscopy within the 3 years prior to study.
- Family history among first degree relatives of colorectal cancer or inflammatory bowel disease.
- Individuals diagnosed with psychiatric disease (e.g., bipolar disorder, Schizophrenia) with or without medication in the last three years.
- Individuals currently on medication for anxiety and/or depression
- Individual has a history and/or presence of other clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the participants, e.g.:
- thyroid gland disorder
- hypertension
- diabetes mellitus
- eating disorder
- immunodeficiency
- relevant gynecological or urological disorder
- any other relevant serious organ or systemic diseases ( e.g., cardiovascular, respiratory, liver, renal, neurological disease, etc.)
- Regular medication and/or supplementation within the last month prior to and planned during the study:
- antibiotics, probiotics, prebiotics within 4 weeks before enrollment for screening.
- medication for IBS complaints, e.g., bile acid binders (cholestyramine), rifaximin, alosetron, lubiprostone, eluxadoline and linaclotide
- which could influence gastrointestinal functions (e.g., laxatives, opioids, systemic corticosteroids, anti-cholinergics, anti-diarrheals, proton pump inhibitors, H2-blockers, etc.) as per investigator judgement. Exception: ad hoc use of Macrolits.
- Regular use of psychopharmaca (e.g., hypnotics / sedative drugs, anxiolytics, antidepressants, neuroleptics, anticonvulsants) within 3 months prior to study or adaptogens (e.g., ginseng, Ashwagandha, satavari, St. John's Wort) within 6 weeks prior to and during the study.
- Introductions of a specific diet (e.g., low carb, vegan, high fibre, low FODMAP) within last 3 months prior to and during the study.
- Women of child-bearing potential: pregnancy or nursing.
- History of or current abuse of drugs, alcohol, tobacco/nicotine or medica tion.
- Participation in another study during the last 30 days prior to and during the study.
- Any other reason for exclusion as per investigator's judgment, e.g., insufficient compliance with study procedures.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
India23 sites
HCG Hospital
Ahmedabad, Gujarat, 380006
GCS Medical College, Hospital & Research Centre
Gujarat, 380025
Nand Hospital
Gujarat, 390015
Maharaja Agrasen Superspeciality Hospital
Jaipur, Rajasthan, 302039
Maharaja Agrasen Superspeciality Hospital
Jaipur
Birch Multispeciality Hospital
Maharashtra, 411041
Lifeline multispeciality hospital
Maharashtra, 412101
Stress Test Clinic
Mumbai, Maharashtra, 400059
Criticare Asia Multispeciality Hospital & Research Centre
Mumbai, Maharashtra, 400069
Surya Multispeciality Hospital
Nashik, Maharashtra, 422003
Astha Clinic
Nashik, Maharashtra, 422011
Astha Clinic
Nashik
Apollo Hospital
Navi Mumbai, Maharashtra, 400614
Mata Roop Rani Maggo Hospital & IVF Center
New Delhi, 110059
Swara Hospital
Pālghar, Maharashtra, 401303
Gastrohub Hospital
Pune, Maharashtra, 411027
Umarji Mother and Child Care Hospital
Pune, Maharashtra, 411045
Lifeline Multispeciality Hospital
Pune, Maharashtra, 412101
Asian Institute of Medical sciences
Thane, Maharashtra, 421203
Ford Hospital
Uttar Pradesh, 221005
Human care hospital
Uttar Pradesh, 226012
Anand Multispeciality Hospital
Vadodara, Gujarat, 390016
Samvedna Hospital
Varanasi, Uttar Pradesh, 221005
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Clinical Study to Assess Effects of Postbiotic vs. Placebo in Participants With Moderate to Severe Diarrhea-predominant Irritable Bowel Syndrome
The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study that assesses the effect of postbioc on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome (IBS-D). The trial is also evaluating the potential of postbiotic on anxiety, low mood and stress of the participants, as well as its safety and tolerability.
The intervention duration for all the study participants is 12 weeks (intervention phase). Subsequently, the participants will be invited to return to site for an end of study assessment after 21 days of no intervention (post-intervention phase).
- Being tested
- Postbiotic, Placebo
- Keywords
- IBS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostbioticDietary supplement
1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks
PlaceboDietary supplement
1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Postbiotic | Experimental | 1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks Receives: Dietary Supplement: Postbiotic |
| Placebo | Placebo comparator | 1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact of Investigational Product relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome.
A responder is defined as a participant who has a decrease in IBS-SSS of at least 50 points (minimal clinically important difference or MCID)
Measured: Baseline (Day 0), and Week 12 (Day 84)
Secondary outcomes (13)
To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the IBS-SSS from baseline at week 8
A responder is defined as a participant who has a decrease in IBS-SSS of at least 50 points (minimal clinically important difference or MCID)
Measured: Baseline (Day 0) and Week 8 (Day 56)
To assess the impact of the Investigational Product in comparison to placebo on mean change in Generalized Anxiety Disorder (GAD)-7 score
The GAD-7 scores are calculated by assigning scores of 0, 1, 2, and 3 to the response categories. GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety and 15-21: severe anxiety. The change from baseline in GAD#7 scores will be assessed.
Measured: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the GAD-7 from baseline at week 12.
The GAD-7 scores are calculated by assigning scores of 0, 1, 2, and 3 to the response categories. GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety and 15-21: severe anxiety. The change from baseline in GAD#7 scores will be assessed. A decrease in GAD-7 of at least 4 points compared to baseline is considered clinically meaningful improvement.
Measured: Baseline (Day 0) and Week 12 (Day 84)
To assess the impact of the Investigational Product in comparison to placebo on mean change in Patient Health Questionnaire (PHQ)-9 score
The PHQ-9 is the 9-item depression module. As a severity measure, the PHQ-9 score can range from 0 to 27. The score will be interpreted as follows: 0-4: None - Minimal 5-9: Mild 10-14: Moderate 15-19: Moderately severe 20-27: Severe
Measured: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the PHQ-9 from baseline at week 12.
The PHQ-9 is the 9-item depression module. As a severity measure, the PHQ-9 score can range from 0 to 27. The score will be interpreted as follows: 0-4: None - Minimal 5-9: Mild 10-14: Moderate 15-19: Moderately severe 20-27: Severe. . A decrease in PHQ-9 of at least 2 points compared to baseline.
Measured: Baseline (Day 0) and Week 12 (Day 84)
To assess the impact of the Investigational Product in comparison to placebo on mean change in Perceived Stress Scale (PSS)
The questions in this scale ask about feelings and thoughts of an individual during the last month.Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on mean change in Bristol Stool Form Score (BSFS)
BSFS is expressed as decrease in the % of abnormal stool consistencies (and thus increase in the % with normal consistency).
Measured: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on occurrence of normal BSFS score at the end of the study
BSFS is expressed as decrease in the % of abnormal stool consistencies (and thus increase in the % with normal consistency).
Measured: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on the quality of life as assessed by the mean change in IBS-QOL scores
It measures 8 disease-relevant domains: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual and relationship issues. It is a 34#item questionnaire with each item rated on a 5# point scale (34-170), with increasing scores indicating the deteriorating quality of life.
Measured: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on mean change in IBS-SSS value
A responder is defined as a participant who has a decrease in IBS-SSS of at least 50 points (minimal clinically important difference or MCID)
Measured: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on compliance with the intake of the investigational product
A diary will be provided to the participant for ensuring compliance. The participant will be asked to fill IP missed or lost details in the diary.
Measured: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on Safety and tolerance
Adverse events, Vital signs (Pulse Rate, Blood Pressure), Liver Function test, Renal Function Test, Complete Blood Count
Measured: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on the impact of IBS on their quality of life using the IBS-Quality of Life (IBS-QoL) instrument.
It measures 8 disease-relevant domains: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual and relationship issues. It is a 34#item questionnaire with each item rated on a 5# point scale (34-170), with increasing scores indicating the deteriorating quality of life. A decrease of 10 points or more is considered a clinically meaningful improvement.
Measured: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start18 Jul 2024
- Primary completion29 May 2025
- Study completion13 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea-Predominant 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, Placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- A-Mansia Biotech S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vedic Lifesciences Pvt. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346847
- Sponsor's protocol ID
- TAC/231001/AKM/IBS
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2024
- Last updated
- 23 Mar 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Parallel Group Clinical Study to Assess Effects of Postbiotic vs. Placebo in Participants With Moderate to Severe Diarrhea-predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06346847
- Acronym / sponsor ID
- TAC/231001/AKM/IBS
- Keywords
- IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- A-Mansia Biotech S.A.Industry (pharma, biotech, devices)
- Collaborators
- Vedic Lifesciences Pvt. Ltd.
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 13 Jul 2025 (actual)
- First posted
- 4 Apr 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.
The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study that assesses the effect of postbioc on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome (IBS-D). The trial is also evaluating the potential of postbiotic on anxiety, low mood and stress of the participants, as well as its safety and tolerability.
The intervention duration for all the study participants is 12 weeks (intervention phase). Subsequently, the participants will be invited to return to site for an end of study assessment after 21 days of no intervention (post-intervention phase).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double-blind, Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Postbiotic | Experimental | Dietary Supplement: Postbiotic1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Men and women from 18 to 55 years old.
- Individuals diagnosed for IBS within the last two years, and meets Rome-IV criteria for IBS: recurrent abdominal pain on average ≥1 day/week in ≥3 months prior to study (with symptom onset ≥6 months prior to study), associated with ≥2 of the following criteria:
- Has IBS-D, i.e., more than ¼ (25%) of bowel movements with Bristol stool types 6 or 7 and less than ¼ (25%) of bowel movements with Bristol stool types 1 or 2); in other words, put practically and as per FDA: at least 2 days per week with at least one stool that has a consistency of Type 6 or Type 7 BSS.
- Has an IBS-SSS of at least 175 points at screening.
- Individuals either with abdominal pain or discomfort (≥ 6 to ≤ 10 on an 11-point scale).
Key exclusion criteria (30 listed)
- Known allergy or hypersensitivity to the components of the investigational product.
- Smokers
- Lactose or fructose intolerance.
- Individuals with uncontrolled hypertension as assessed by systolic blood pressure ≥ to 160 mmHg and diastolic blood pressure ≥ to 100mmHg.
- History of diverticulitis, intestinal obstruction, stricture, toxic megacolon, GI (gastro-intestinal) perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g., aorto-iliac disease) or recent unexplained GI bleeding within 3 months prior to screening.
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 |
|---|---|---|
| Postbiotic1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks | Dietary supplement | Postbiotic |
| Placebo1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks | Dietary supplement | Placebo |
Primary outcome
To assess the impact of Investigational Product relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome.
Time frame: Baseline (Day 0), and Week 12 (Day 84)
A responder is defined as a participant who has a decrease in IBS-SSS of at least 50 points (minimal clinically important difference or MCID)
13 secondary outcomes
To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the IBS-SSS from baseline at week 8
Time frame: Baseline (Day 0) and Week 8 (Day 56)
To assess the impact of the Investigational Product in comparison to placebo on mean change in Generalized Anxiety Disorder (GAD)-7 score
Time frame: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the GAD-7 from baseline at week 12.
Time frame: Baseline (Day 0) and Week 12 (Day 84)
To assess the impact of the Investigational Product in comparison to placebo on mean change in Patient Health Questionnaire (PHQ)-9 score
Time frame: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the PHQ-9 from baseline at week 12.
Time frame: Baseline (Day 0) and Week 12 (Day 84)
To assess the impact of the Investigational Product in comparison to placebo on mean change in Perceived Stress Scale (PSS)
Time frame: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on mean change in Bristol Stool Form Score (BSFS)
Time frame: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on occurrence of normal BSFS score at the end of the study
Time frame: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on the quality of life as assessed by the mean change in IBS-QOL scores
Time frame: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on mean change in IBS-SSS value
Time frame: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on compliance with the intake of the investigational product
Time frame: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on Safety and tolerance
Time frame: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
To assess the impact of the Investigational Product in comparison to placebo on the impact of IBS on their quality of life using the IBS-Quality of Life (IBS-QoL) instrument.
Time frame: Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)
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 23 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postbiotic in people with Diarrhea-Predominant Irritable Bowel Syndrome, run by A-Mansia Biotech S.A. at 23 sites 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 19 inclusion and 30 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 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
To assess the impact of Investigational Product relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome. (time frame: Baseline (Day 0), and Week 12 (Day 84)). 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 23 Mar 2026.