IBS (Irritable Bowel Syndrome)DORPHINCT06889779
Study Evaluating the Efficacy of Different Mixes of HMO-2FL + Humiome® Post LB on IBS Gastrointestinal Symptoms
A study testing MIX 1 and MIX 2 in people with IBS (Irritable Bowel Syndrome), run by dsm-firmenich Switzerland AG at 12 sites in India.
Trial summary
A randomized, placebo-controlled, double-blind clinical study to evaluate the efficacy of two different mixes of HMO-2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on Gastrointestinal Symptoms in individuals with Irritable Bowel Syndrome (IBS) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IBS (Irritable Bowel Syndrome)
- What is being tested?
- MIX 1 and MIX 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 353 participants
- Where
- 12 sitesIndia
- Study dates
- 27 Mar 2025to 6 Jun 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Individuals with IBS-M.
- Treatment with an investigational drug within 30 days/5 half-lives of the drug (whichever longest) prior to screening visit.
- Individuals with organic disease like infectious diseases, inflammatory diseases, metabolic disorders, neurological diseases, autoimmune disorders, cancer etc. (to be ruled out by physician based on prior history and physical examination).
- Individuals with a history of surgical resection of the stomach, small intestine or large intestine.
- Individuals with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis), colitis and enteritis.
- Individuals with a history of any diet-based intolerance (gluten or lactose intolerance).
Show all 26Show fewer
- Individuals with a history of drug or alcohol abuse within the past 6 months.
- Individuals with severe depression or an anxiety disorder, which could potentially affect the efficacy evaluation (as determined by the qualified investigator).
- Individuals with uncontrolled hypertension or on antihypertensive medications.
- Individuals with serious cardiovascular diseases, respiratory diseases, renal diseases, hepatic diseases, gastrointestinal diseases (excluding IBS), blood diseases or neurological or psychiatric diseases.
- Individuals who are pregnant, breastfeeding or planning on becoming pregnant throughout the course of the study.
- Individuals with Type I or Type II diabetes mellitus.
- Individuals with a history of or current diagnosis of any cancer diagnosed less than 5 years prior to screening. Individuals with cancer in full remission more than 5 years after diagnosis are acceptable.
- Individuals who are immuno-compromised (HIV positive, on antirejection medication, rheumatoid arthritis and other autoimmune disorders).
- Individuals with a history of abdominal surgery.
- Individuals with diarrhoea of any other origin.
- Individuals currently or in future planning to fast for more than 24 hours.
- Individuals with an active eating disorder.
- Individuals who have used an over-the-counter or prescription laxative medication or any other herbal agents affecting GI motility within 2 weeks prior to screening.
- Individuals who have used pre/pro/post/synbiotic, Human Milk Oligosaccharides (HMOs), or fiber supplements (or probiotic/fiber enriched foods) or FODMAP diet or an antibiotic within 4 weeks prior to screening.
- Individuals who have used IBS specific treatments within 4 weeks prior to screening.
- Individuals who currently consume greater than 2 standard alcoholic drinks per day from past 3 months. ((One unit of alcohol is equal to 45 ml of hard liquor, 150 ml of wine or a pint of beer)
- Smokers (in any number and any format)
- Individuals with an allergy or sensitivity to the probiotic products.
- Individuals who are cognitively impaired and/or who are unable to give an informed consent.
- Individuals who have abnormal laboratory results or any other medical or psychological condition which, in the opinion of the qualified investigator, may adversely affect the Individuals' ability to complete the study or its measures or which may pose significant risk to the individual.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Shivam Hospital
Dombivali, Maharashtra, 421201
Gleneagles Global Hospitals
Hyderabad, Telangana, 500004
Jaipur National University Institute of Medical Sciences and Research Centre
Jaipur, Rajasthan, 302017
Aster Aadhar Hospital
Kolhāpur, Maharashtra, 416012
D Y Patil
Navi Mumbai, Maharashtra, 400706
Samvedna Hospital
New Colony, Ravindrapuri Varanasi, 221005
Dr. Naresh Bansal's Gastro & Liver Clinic
New Delhi, National Capital Territory of Delhi, 110058
Dhanwantari Hospital
Pune, Maharashtra, 411002
Silver Birch
Pune, Maharashtra, 411041
Vishwaraj hospital
Pune, Maharashtra, 412201
D Y Patil Hospital, Medical college and research centre
Thane, Maharashtra, 400706
Shri. B. M. PatilMedical College,Hospital andResearch Centre
Vijayapura, Karnataka, 586103
About this study
Official title: A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of Two Different Mixes of HMO-2FL + Humiome® Post LB Postbiotic (Postbiotic-LB) on Gastrointestinal Symptoms in Irritable Bowel Syndrome (IBS) Subjects
A randomized, placebo-controlled, double-blind clinical study to evaluate the efficacy of two different mixes of HMO-2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on Gastrointestinal Symptoms in individuals with Irritable Bowel Syndrome (IBS)
Read the detailed description
This study is a randomized, placebo-controlled, double-blind clinical trial designed to assess the efficacy of two distinct formulations combining Human Milk Oligosaccharide 2'-O-fucosyllactose (HMO-2FL) with Humiome® Post LB postbiotic (postbiotic-LB) in alleviating gastrointestinal symptoms in individuals with Irritable Bowel Syndrome (IBS). Participants will be randomly assigned to receive either of the two active formulations or a placebo, ensuring unbiased comparisons. We aim to evaluate changes in gastrointestinal symptoms, including abdominal pain, bloating, and bowel movement patterns, using validated symptom scoring tools. We will assess the quality of life, gut health biomarkers, and safety profiles. The study employs a double-blind design, where neither participants nor investigators will know the treatment assignments, maintaining the study's integrity. By comparing the effects of different HMO-2FL and postbiotic-LB combinations, this trial aims to provide evidence-based insights into novel dietary supplement options for IBS management, contributing to the growing field of gut health and microbiome-targeted solutions.
- Conditions
- IBS (Irritable Bowel Syndrome)
- Being tested
- MIX 1, MIX 2, Placebo
- Keywords
- Dietary supplement IBS
- 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.
MIX 1Dietary supplement
Humiome® Post LB postbiotic 300 mg , Human Milk Oligosaccharides 2'-Ofucosyllactose 300 mg 1 capsule per day Orally
MIX 2Dietary supplement
Humiome® Post LB postbiotic 100 mg Human Milk Oligosaccharides 2'-O-fucosyllactose 500 mg 1 capsule per day Orally
PlaceboDietary supplement
Microcrystalline cellulose 1 capsule per day Orally
| Study group | Role | What they receive |
|---|---|---|
| MIX 1 | Active comparator | Humiome® Post LB postbiotic 300 mg , Human Milk Oligosaccharides 2'-O-fucosyllactose 300 mg 1 capsule per day orally Receives: Dietary Supplement: MIX 1 |
| MIX 2 | Active comparator | Humiome® Post LB postbiotic 100 mg Human Milk Oligosaccharides 2'-O-fucosyllactose 500 mg 1 capsule per day orally Receives: Dietary Supplement: MIX 2 |
| Placebo | Placebo comparator | Microcrystalline 1 capsule per day orally Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on IBS symptoms as assessed by IBS Symptom Severity Scale (IBS-SSS), when compared to placebo
The IBS Severity Scoring System (IBS-SSS) will be used to assess symptom severity. Participants will rate their symptoms over the last 10 days on day 0 and day 42. The change in the average IBS severity score will be calculated and compared to the placebo group.
Measured: Day 0 & Day 42
Secondary outcomes (13)
To assess the efficacy of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on IBS symptoms as assessed by IBS Symptom Severity Scale , when compared to placebo in individuals
The IBS Severity Scoring System (IBS-SSS) will be used to assess symptom severity. Participants will rate their symptoms over the last 10 days on day 0 and day 21. The change in the average IBS severity score will be calculated and compared to the placebo group.
Measured: Day 0, Day 21
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on IBS symptoms as assessed by IBS-SSS, when compared to baseline in individuals with IBS
The IBS Severity Scoring System (IBS-SSS) will be used to assess symptom severity. Participants will rate their symptoms over the last 10 days on day 0 and day 42. The change in the average IBS severity score will be calculated and compared to baseline in individuals with IBS.
Measured: Day 0, Day 21 and Day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on Abdominal Pain severity compared to baseline, each other and placebo in individuals with
Decrease in Abdominal pain severity as assessed by APS-NRS (Abdominal pain severity - Numeric rating scale)
Measured: Day 0, Day 21 and Day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on participant by Stool consistency (Bristol Stool Form Scale types 3, 4 & 5)
In gastroenterology, stool consistency is commonly measured using the Bristol Stool Form Scale (BSFS), which categorizes stool into seven types, from type 1 (hard lumps) to type 7 (watery diarrhea). It is a simple, cost-effective tool used as a marker for intestinal transit time and bowel function. In this study, stool consistency will be assessed using the BSFS.
Measured: Time Frame: Day 0, Day 21 and Day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on participant by Quality of Life score as assessed by IBS- QoL questionnaire
The quality of life will be assessed using the IBS-QOL scale. The participants will be asked to score based on their symptoms in the last month at day 0, day 21, and day 42.
Measured: day 0, day 21, and day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on participant by decreased Abdominal bloating as assessed by Gastrointestinal Quality of Life
The Gastrointestinal Quality of Life Index (GIQLI) is a validated 36-item tool for assessing health-related quality of life across five domains: core symptoms (10 items), physical (6 items), psychological (6 items), social (2 items), and disease-specific (8 items). Each item uses a 0-4 Likert scale, with higher scores indicating better quality of life. Total scores range from 0 to 144, where higher scores reflect improved quality of life.
Measured: day 0, day 21, and day 42
To assess the efficacy on Increased percentage of responders to the treatment based on improvement on primary objective. The IBS-SSS is responsive to treatment; therefore, it has been used as a valid tool for performing responder analysis in IBS studies.
The number of responders will be calculated separately for the two definitions given below in the present study:
- 50 points change in IBS-SSS total score from baseline.
- 95 points change in IBS-SSS total score from baseline.
Measured: day 0, day 21 and day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on daily number of stool sample
Will be assessed by Reduced Daily number of stools (stool frequency, assessed per IBS sub-type
Measured: Daily from start of the study to Week 6
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on Absolute difference in rescue medication consumption in active and placebo groups.
Reduced Absolute difference in rescue medication consumption
Measured: Daily from start of the study to Week 6
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on Subjective global assessment of IP tolerability by participants.
Will be measured by subjective global assessment of IP tolerability by participants
Measured: Daily from start of the study to Week 6
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on IBS-related mental stress relief
Will be measured by Perceived stress scale (PSS)
Measured: Day 0 and day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB on Gut Permeability assessment (Lactulose to Mannitol ratio test) [to be conducted in 30 participants in each arm]
Will be measured by measuring the decrease in Lactulose Mannitol ratio (30 Participants per arm)
Measured: Day 0 and day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on Stool pH & redox [to be conducted in 30 participants in each arm]
Improved Stool pH (5.5 to 7.0) \& decreased redox potential of stool [to be conducted in those participants who are undergoing LMR in each arm
Measured: Day 0 and day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start27 Mar 2025
- Primary completion6 Jun 2026
- Study completion6 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS (Irritable Bowel Syndrome)Studies 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
- Parallel Assignment A randomized, placebo-controlled, double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mehdi Sadaghian, PhD, Study director, dsm-firmenich Switzerland AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889779
- Sponsor's protocol ID
- 2023-08-14-DORP
- Acronym
- DORPHI
- Status last verified
- Jul 2026
- First submitted
- 20 Feb 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of Two Different Mixes of HMO-2FL + Humiome® Post LB Postbiotic (Postbiotic-LB) on Gastrointestinal Symptoms in Irritable Bowel Syndrome (IBS) Subjects
- ClinicalTrials.gov ID
- NCT06889779
- Acronym / sponsor ID
- DORPHI / 2023-08-14-DORP
- Conditions
- IBS (Irritable Bowel Syndrome)
- Keywords
- Dietary supplement IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 6 Jun 2026 (actual)
- Study completion
- 6 Jun 2026 (actual)
- First posted
- 21 Mar 2025 (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.
A randomized, placebo-controlled, double-blind clinical study to evaluate the efficacy of two different mixes of HMO-2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on Gastrointestinal Symptoms in individuals with Irritable Bowel Syndrome (IBS)
Detailed description
This study is a randomized, placebo-controlled, double-blind clinical trial designed to assess the efficacy of two distinct formulations combining Human Milk Oligosaccharide 2'-O-fucosyllactose (HMO-2FL) with Humiome® Post LB postbiotic (postbiotic-LB) in alleviating gastrointestinal symptoms in individuals with Irritable Bowel Syndrome (IBS). Participants will be randomly assigned to receive either of the two active formulations or a placebo, ensuring unbiased comparisons. We aim to evaluate changes in gastrointestinal symptoms, including abdominal pain, bloating, and bowel movement patterns, using validated symptom scoring tools. We will assess the quality of life, gut health biomarkers, and safety profiles. The study employs a double-blind design, where neither participants nor investigators will know the treatment assignments, maintaining the study's integrity. By comparing the effects of different HMO-2FL and postbiotic-LB combinations, this trial aims to provide evidence-based insights into novel dietary supplement options for IBS management, contributing to the growing field of gut health and microbiome-targeted solutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment A randomized, placebo-controlled, double-blind
| Arm | Type | Receives |
|---|---|---|
| MIX 1 | Active comparator | Dietary Supplement: MIX 1Humiome® Post LB postbiotic 300 mg , Human Milk Oligosaccharides 2'-O-fucosyllactose 300 mg 1 capsule per day orally |
| MIX 2 | Active comparator | Dietary Supplement: MIX 2Humiome® Post LB postbiotic 100 mg Human Milk Oligosaccharides 2'-O-fucosyllactose 500 mg 1 capsule per day orally |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMicrocrystalline 1 capsule per day orally |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (26 listed)
- Individuals with IBS-M.
- Treatment with an investigational drug within 30 days/5 half-lives of the drug (whichever longest) prior to screening visit.
- Individuals with organic disease like infectious diseases, inflammatory diseases, metabolic disorders, neurological diseases, autoimmune disorders, cancer etc. (to be ruled out by physician based on prior history and physical examination).
- Individuals with a history of surgical resection of the stomach, small intestine or large intestine.
- Individuals with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis), colitis and enteritis.
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 |
|---|---|---|
| MIX 1Humiome® Post LB postbiotic 300 mg , Human Milk Oligosaccharides 2'-Ofucosyllactose 300 mg 1 capsule per day Orally | Dietary supplement | MIX 1 |
| MIX 2Humiome® Post LB postbiotic 100 mg Human Milk Oligosaccharides 2'-O-fucosyllactose 500 mg 1 capsule per day Orally | Dietary supplement | MIX 2 |
| PlaceboMicrocrystalline cellulose 1 capsule per day Orally | Dietary supplement | Placebo |
Primary outcome
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on IBS symptoms as assessed by IBS Symptom Severity Scale (IBS-SSS), when compared to placebo
Time frame: Day 0 & Day 42
The IBS Severity Scoring System (IBS-SSS) will be used to assess symptom severity. Participants will rate their symptoms over the last 10 days on day 0 and day 42. The change in the average IBS severity score will be calculated and compared to the placebo group.
13 secondary outcomes
To assess the efficacy of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on IBS symptoms as assessed by IBS Symptom Severity Scale , when compared to placebo in individuals
Time frame: Day 0, Day 21
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on IBS symptoms as assessed by IBS-SSS, when compared to baseline in individuals with IBS
Time frame: Day 0, Day 21 and Day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on Abdominal Pain severity compared to baseline, each other and placebo in individuals with
Time frame: Day 0, Day 21 and Day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on participant by Stool consistency (Bristol Stool Form Scale types 3, 4 & 5)
Time frame: Time Frame: Day 0, Day 21 and Day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on participant by Quality of Life score as assessed by IBS- QoL questionnaire
Time frame: day 0, day 21, and day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose + Humiome® Post LB postbiotic on participant by decreased Abdominal bloating as assessed by Gastrointestinal Quality of Life
Time frame: day 0, day 21, and day 42
To assess the efficacy on Increased percentage of responders to the treatment based on improvement on primary objective. The IBS-SSS is responsive to treatment; therefore, it has been used as a valid tool for performing responder analysis in IBS studies.
Time frame: day 0, day 21 and day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on daily number of stool sample
Time frame: Daily from start of the study to Week 6
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on Absolute difference in rescue medication consumption in active and placebo groups.
Time frame: Daily from start of the study to Week 6
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on Subjective global assessment of IP tolerability by participants.
Time frame: Daily from start of the study to Week 6
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on IBS-related mental stress relief
Time frame: Day 0 and day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB on Gut Permeability assessment (Lactulose to Mannitol ratio test) [to be conducted in 30 participants in each arm]
Time frame: Day 0 and day 42
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on Stool pH & redox [to be conducted in 30 participants in each arm]
Time frame: Day 0 and day 42
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 22 Jul 2026.
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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.
Mehdi Sadaghian, PhD study director
dsm-firmenich Switzerland AG
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIX 1 and MIX 2 in people with IBS (Irritable Bowel Syndrome), run by dsm-firmenich Switzerland AG at 12 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 0 inclusion and 26 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 22 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 12 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 efficacy of 6 weeks of daily consumption of two different mixes of HMO 2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on IBS symptoms as assessed by IBS Symptom Severity Scale (IBS-SSS), when compared to placebo (time frame: Day 0 & Day 42). 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 22 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.