Clinical trial NCT05807919: Evaluating the Efficacy of the Mediterranean Diet to the Low- Fermentable, Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Diet in Treating Irritable Bowel Syndrome(IBS)
Official title: Evaluate and Compare the Clinical Efficacy of the Mediterranean Diet to the Low-FODMAP Diet in Treating Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Low FODMAP Diet
Mediterranean Diet
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: ModifyHealth
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-04-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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).

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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.

Primary outcomes:
measure: Proportion of Participants Who Are Responders Based on the Abdominal Pain Intensity Score for at Least 2 of 4 Weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of Participants Who Are Weekly Responders to Adequate Relief Symptom Assessment for at Least 2 of 4 Weeks
timeFrame: 4 weeks
measure: 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
timeFrame: 4 weeks
measure: Change in Mean Score of the Irritable Bowel Severity Scoring System (IBS-SSS) Modified Version
timeFrame: Baseline, 4 weeks
measure: Proportion of Participants Who Are Weekly Responders to Bloating for at Least 2 of the 4 Weeks
timeFrame: 4 weeks
measure: Participants Who Are Weekly Responders to Stool Consistency Based on the Bristol Stool Scale (BSS) for at Least 2 of the 4 Weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Prashant Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: