Phase
Condition
Stomach Discomfort
Colic
Bowel Dysfunction
Treatment
a low FODMAP diet for 4 weeks
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein or fecal calprotectin, complete blood count since the onset of symptoms.
Normal stool studies including, ova and parasites since the onset of symptoms
IBS-SSS score of ≥175 at the end of the 7-day screening period
In case of presence of any alarm features and/or elevated inflammatory markers (C-reactive protein or fecal calprotectin), patients will be eligible if they have been excluded for inflammatory bowel disease with colonoscopy in the last one year.
Exclusion criteria
individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
individuals with any known food allergy or insulin-dependent diabetes
known history of celiac disease, inflammatory bowel disease or microscopic colitis
prior small bowel or colonic surgery or cholecystectomy
pregnant patients
Antibiotics in the past 3 months
Those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.
Study Design
Connect with a study center
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
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