Irritable Bowel SyndromeNCT05972317
IBS Personalized Diet vs. Low FODMAP Diet Randomized Control Trial
A study testing Standard Low FODMAP dietary regimen and personalized low FODMAP dietary regimen in people with Irritable Bowel Syndrome, run by Weizmann Institute of Science at 1 site in Israel.
Trial summary
Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in humans, with an estimated global prevalence of 11%-20% of all humans. Alterations in the gut microbiome are at the center of IBS, and microbiome-induced volatile metabolites in response to dietary exposures is believed to drive a… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Standard Low FODMAP dietary regimen and personalized low FODMAP dietary regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 11 May 2026to Nov 2029
- Phase
- Interventional
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
- Male and Female
- Age - 18-70
Who cannot join
- Consumption of antibiotics 2 months prior to enrolment.
- Consumption of probiotic supplements 2 weeks prior to enrolment.
- Type 1 or type 2 diabetes diagnosis.
- Pregnancy, fertility treatments, breastfeeding 3 months prior to the first day of the study.
- Chronic disease - to the discretion of the study medical team.
- Cancer and recent anticancer treatment.
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- Immunosuppression.
- Psychiatric disorders - to the discretion of the medical team
- History of gastrointestinal surgeries - to the discretion of the medical team
- Inflammatory bowel diseases or gastrointestinal disorders - to the discretion of the medical team
- Unstable doses of medications in the past 2 months
- Alcohol or substance abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shimrit Eliyahu Miller contact
Israel1 site, 1 recruiting
- Recruiting
Weizmann institute of science
Rehovot
Yotam Cohen
About this study
Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in humans, with an estimated global prevalence of 11%-20% of all humans. Alterations in the gut microbiome are at the center of IBS, and microbiome-induced volatile metabolites in response to dietary exposures is believed to drive a downstream impact on susceptible hosts, thereby driving the disease. However, the characteristics and functions of these metabolites remain unknown to date. This placebo-controlled interventional study examines person-specific small molecules and bacteria driving IBS and their downstream effects on the human gut epithelium.
Read the detailed description
This interventional study will include volunteers who are suspected of suffering from IBS. They will be asked to fill several questionnaires: Rome IV Diagnostic Questionnaire for Irritable Bowel Syndrome (R4DQ), irritable bowel syndrome - Symptom Severity Scale (IBS-SSS), irritable bowel syndrome - Quality of Life survey (IBS-QOL) and a food frequency questionnaire (FFQ). Blood tests including Celiac serology will be taken, as well as stool for home Calprotectin test. participants will be asked to collect stool samples at home.
If the participant has a recent, relevant medical documents, they will be asked to provide them to the study team for further evaluation of IBS diagnosis.
Gastroenterologist will receive anonymized patients data - for validation and final diagnosis of IBS.
At the end of the screening period, participants without a gastroenterologist's approval - will end their participation in the study, whereas participants who will be deemed fit, will continue to the next phase and will be allocated randomly to one of the two arms to start the nutritional intervention:
- Standard low FODMAP dietary regimen randomized re-introduction phase
- Standard low FODMAP dietary regimen with personalized re-introduction phase
Participants will be asked to record daily activities, food intake, Bristol stool scale, and symptoms on a smartphone application during the elimination and reintroduction phases. Participants will be given kits to collect stool samples at home during all study phases.
The dietitian follow-up meetings will be held on a weekly basis during the elimination and re-introduction phases via phone/video call or frontal meeting. Dietitian counseling will include the Monash University's low FODMAP diet app guidance.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Standard Low FODMAP dietary regimen, personalized low FODMAP dietary regimen
- 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.
Standard Low FODMAP dietary regimenOther
Standard low FODMAP dietary regimen randomized re-introduction phase
personalized low FODMAP dietary regimenOther
Low FODMAP dietary regimen with personalized re-introduction phase
| Study group | Role | What they receive |
|---|---|---|
| IBS - standard low FODMAP | Placebo comparator | individuals that are diagnosed with IBS according to Rome IV criteria Standard low FODMAP dietary regimen randomized re-introduction phase Receives: Other: Standard Low FODMAP dietary regimen |
| IBS - personalised low FODMAP | Experimental | individuals that are diagnosed with IBS according to Rome IV criteria FODMAP dietary regimen with personalized re-introduction phase Receives: Other: personalized low FODMAP dietary regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool microbiome composition
metagenomic sequencing of stool samples
Measured: 4 months
Secondary outcomes (1)
IBS-SSS - irritable bowel syndrome severity score system questionnaire
Severity of symptoms as they are scored in the Rome IV IBS-SSS 75 to <175 to indicate mild IBS, 175 to <300 as moderate, and >300 as severe
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start11 May 2026
- Primary completionJan 2028 (estimated)
- Study completionNov 2029 (estimated)
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weizmann Institute of Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eran Elinav, Prof, Principal investigator, Weizmann Institute of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972317
- Sponsor's protocol ID
- 3328-1
- Status last verified
- May 2026
- First submitted
- 2 Mar 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No