Irritable Bowel SyndromeNCT05807919
Evaluating the Efficacy of the Mediterranean Diet to the Low- Fermentable, Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Diet in Treating Irritable Bowel Syndrome(IBS)
A study testing Diet low in all FODMAP groups and Diet - Mediterranean in people with Irritable Bowel Syndrome, run by University of Michigan at 1 site in United States.
Trial summary
This study is being completed to determine if the Mediterranean (MD) and low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diets are comparable in the effectiveness to treat Irritable Bowel Syndrome (IBS). 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?
- Diet low in all FODMAP groups and Diet - Mediterranean
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 3 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with IBS-D (diarrhea-predominant IBS) or IBS-M (IBS with mixed subtype) diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, personal history of celiac disease, microscopic colitis, inflammatory bowel disease)
- Aged 18-70 years at the time of screening
- Weekly average of worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0-to-10-point scale
- At least 80 percent compliance in daily questionnaire entries during the 7-day screening period
Who cannot join
- Subjects adhering to any dietary IBS treatment such as the low-fodmap diet, or gluten-free diet, Mediterranean currently or within the past 6 months
- Subjects with a known food allergy to eggs, seafood, peanuts, tree nuts or milk (subjects with lactose intolerance that are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study).
- Subjects with a history of poorly controlled insulin-dependent or non-insulin-dependent diabetes
- Subjects with a known history of organic Gastrointestinal (GI) disease (i.e., celiac disease, inflammatory bowel disease or microscopic colitis)
- Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
- Subjects with prior small bowel or colonic surgery (excluding appendectomy or cholecystectomy if over 6 months since these 2 procedures)
Show all 9Show fewer
- Oral antibiotic use in the past 3 months
- Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study.
- Currently pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate and Compare the Clinical Efficacy of the Mediterranean Diet to the Low-FODMAP Diet in Treating Irritable Bowel Syndrome
This study is being completed to determine if the Mediterranean (MD) and low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diets are comparable in the effectiveness to treat Irritable Bowel Syndrome (IBS).
The study team hypothesizes that:
- The low FODMAP and Mediterranean groups will achieve a similar improvement in abdominal pain
- Both groups will achieve similar improvements in bloating, overall IBS symptom severity, and adequate relief
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Diet low in all FODMAP groups, Diet - Mediterranean
- Keywords
- Low FODMAP Diet, Mediterranean Diet
- 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.
Diet low in all FODMAP groupsOther
Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
Diet - MediterraneanOther
Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
| Study group | Role | What they receive |
|---|---|---|
| Diet low in all FODMAP groups | Experimental | Not described Receives: Other: Diet low in all FODMAP groups |
| Diet - Mediterranean | Experimental | Not described Receives: Other: Diet - Mediterranean |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Are Responders Based on the Abdominal Pain Intensity Score for at Least 2 of 4 Weeks
Results reflect the participants who were weekly responders for at least 2 of the 4 weeks based on their abdominal pain intensity score. The abdominal pain score was a single-question, 11-point numeric rating scale in which 0 represented no abdominal pain and 11 represented the worst possible abdominal pain. Once per day, subjects reported their worst daily (in the past 24 hours) abdominal pain. A weekly responder was defined as a participant whose score decreased in the weekly average of worst abdominal pain in the past 24 hours by at least 30% compared with baseline.
Measured: 4 weeks
Secondary outcomes (5)
Proportion of Participants Who Are Weekly Responders to Adequate Relief Symptom Assessment for at Least 2 of 4 Weeks
Results reflect the participants who were weekly responders based on the adequate relief symptom assessment for at least 2 of the 4 weeks. Participants provided a binary (yes or no) response to rate the adequacy of relief of global irritable bowel syndrome (IBS) symptoms at the start of the study and weekly thereafter. A weekly responder was defined as a participant who achieved adequate relief in symptoms in at least 2 out of 4 weeks of the treatment period.
Measured: 4 weeks
Proportion of Participants Who Are Weekly Responders Based on the Irritable Bowel Severity Scoring System (IBS-SSS) Modified Version for at Least 2 of the 4 Weeks
Results reflect participants who were weekly responders for at least 2 of the 4 weeks based on their scores on a modified version of the IBS-SSS. This version of the IBS-SSS was comprised of 5 questions participants answered based on their stomach and bowels. The total score for this modified version of the IBS-SSS was 0-500, with 0 indicating no IBS symptoms and 500 indicating the highest amount of IBS symptoms. A weekly responder was defined as a participant whose score decreased in the weekly IBS-SSS by at least 50 points compared with baseline.
Measured: 4 weeks
Change in Mean Score of the Irritable Bowel Severity Scoring System (IBS-SSS) Modified Version
The modified version of the IBS-SSS was comprised of 5 questions participants answered based on their stomach and bowels. The total score for this modified version of the IBS-SSS was 0-500, with 0 indicating no IBS symptoms and 500 indicating the highest amount of IBS symptoms. The results represent the mean change from baseline minus 4 weeks.
Measured: Baseline, 4 weeks
Proportion of Participants Who Are Weekly Responders to Bloating for at Least 2 of the 4 Weeks
Results reflect the number of participants who were weekly responders based on their abdominal bloating score for at least 2 of 4 weeks. The abdominal bloating score was a single-question, 11-point numeric rating scale in which 0 represented no abdominal bloating and 11 represented the worst possible abdominal bloating. Once per day, participants reported their worst daily (in the past 24 hours) abdominal bloating. A weekly responder was defined as a participant whose score decreased in the weekly average of worst bloating in the past 24 hours by at least 30% compared with baseline.
Measured: 4 weeks
Participants Who Are Weekly Responders to Stool Consistency Based on the Bristol Stool Scale (BSS) for at Least 2 of the 4 Weeks
Results reflect the participants who were weekly responders based on their stool consistency assessment for at least 2 of 4 weeks. A stool consistency weekly responder was defined as a participant with a 50% or greater reduction in the number of days per week with at least one abnormal stool. Stools that scored as 1 or 2 (hard stool) or 6 or 7 (liquid stool) on the BSS were defined as abnormal.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start10 Apr 2023
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Subjects meeting all eligibility criteria will be randomized in a 1:1 ratio to receive either the MD or the LFD for a four-week period.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- ModifyHealth, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Prashant Singh, University of Michigan
- Investigators
- Prashant Singh, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807919
- Sponsor's protocol ID
- HUM00227491
- Other IDs
- 5P30DK089503-13
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2023
- Last updated
- 28 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh P, Dean G, Iram S, Peng W, Chey SW, Rifkin S, Lothen-Kline C, Muir J, Lee AA, Eswaran S, Chey WD. Efficacy of Mediterranean Diet vs. Low-FODMAP Diet in Patients With Nonconstipated Irritable Bowel Syndrome: A Pilot Randomized Controlled Trial. Neurogastroenterol Motil. 2025 Oct;37(10):e70060. doi: 10.1111/nmo.70060. Epub 2025 Apr 24.
PubMed 40273380
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate and Compare the Clinical Efficacy of the Mediterranean Diet to the Low-FODMAP Diet in Treating Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05807919
- Acronym / sponsor ID
- HUM00227491
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Low FODMAP Diet, Mediterranean Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- ModifyHealth, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Posted 28 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being completed to determine if the Mediterranean (MD) and low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diets are comparable in the effectiveness to treat Irritable Bowel Syndrome (IBS).
The study team hypothesizes that:
- The low FODMAP and Mediterranean groups will achieve a similar improvement in abdominal pain
- Both groups will achieve similar improvements in bloating, overall IBS symptom severity, and adequate relief
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects meeting all eligibility criteria will be randomized in a 1:1 ratio to receive either the MD or the LFD for a four-week period.
| Arm | Type | Receives |
|---|---|---|
| Diet low in all FODMAP groups | Experimental | Other: Diet low in all FODMAP groups |
| Diet - Mediterranean | Experimental | Other: Diet - Mediterranean |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with IBS-D (diarrhea-predominant IBS) or IBS-M (IBS with mixed subtype) diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, personal history of celiac disease, microscopic colitis, inflammatory bowel disease)
- Aged 18-70 years at the time of screening
- Weekly average of worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0-to-10-point scale
- At least 80 percent compliance in daily questionnaire entries during the 7-day screening period
Key exclusion criteria (9 listed)
- Subjects adhering to any dietary IBS treatment such as the low-fodmap diet, or gluten-free diet, Mediterranean currently or within the past 6 months
- Subjects with a known food allergy to eggs, seafood, peanuts, tree nuts or milk (subjects with lactose intolerance that are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study).
- Subjects with a history of poorly controlled insulin-dependent or non-insulin-dependent diabetes
- Subjects with a known history of organic Gastrointestinal (GI) disease (i.e., celiac disease, inflammatory bowel disease or microscopic colitis)
- Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
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 |
|---|---|---|
| Diet low in all FODMAP groupsRandomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment. | Other | Diet low in all FODMAP groups |
| Diet - MediterraneanRandomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment. | Other | Diet - Mediterranean |
Primary outcome
Proportion of Participants Who Are Responders Based on the Abdominal Pain Intensity Score for at Least 2 of 4 Weeks
Time frame: 4 weeks
Results reflect the participants who were weekly responders for at least 2 of the 4 weeks based on their abdominal pain intensity score. The abdominal pain score was a single-question, 11-point numeric rating scale in which 0 represented no abdominal pain and 11 represented the worst possible abdominal pain. Once per day, subjects reported their worst daily (in the past 24 hours) abdominal pain. A weekly responder was defined as a participant whose score decreased in the weekly average of worst abdominal pain in the past 24 hours by at least 30% compared with baseline.
5 secondary outcomes
Proportion of Participants Who Are Weekly Responders to Adequate Relief Symptom Assessment for at Least 2 of 4 Weeks
Time frame: 4 weeks
Proportion of Participants Who Are Weekly Responders Based on the Irritable Bowel Severity Scoring System (IBS-SSS) Modified Version for at Least 2 of the 4 Weeks
Time frame: 4 weeks
Change in Mean Score of the Irritable Bowel Severity Scoring System (IBS-SSS) Modified Version
Time frame: Baseline, 4 weeks
Proportion of Participants Who Are Weekly Responders to Bloating for at Least 2 of the 4 Weeks
Time frame: 4 weeks
Participants Who Are Weekly Responders to Stool Consistency Based on the Bristol Stool Scale (BSS) for at Least 2 of the 4 Weeks
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40273380Singh P, Dean G, Iram S, Peng W, Chey SW, Rifkin S, Lothen-Kline C, Muir J, Lee AA, Eswaran S, Chey WD. Efficacy of Mediterranean Diet vs. Low-FODMAP Diet in Patients With Nonconstipated Irritable Bowel Syndrome: A Pilot Randomized Controlled Trial. Neurogastroenterol Motil. 2025 Oct;37(10):e70060. doi: 10.1111/nmo.70060. Epub 2025 Apr 24.
- 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.
Prashant Singh, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet low in all FODMAP groups and Diet - Mediterranean in people with Irritable Bowel Syndrome, run by University of Michigan at 1 site in United States.
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 4 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 28 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants Who Are Responders Based on the Abdominal Pain Intensity Score for at Least 2 of 4 Weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05807919, which also lists 1 linked publication.
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 28 Mar 2025.