Evaluating the Efficacy of the Mediterranean Diet to the Low- Fermentable, Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Diet in Treating Irritable Bowel Syndrome(IBS)
Irritable Bowel Syndrome
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Low FODMAP Diet, Mediterranean Diet
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.
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Diet low in all FODMAP groups
Diet - Mediterranean