Phase
Condition
Gastrointestinal Diseases And Disorders
Colic
Lactose Intolerance
Treatment
Diet low in all FODMAP groups
Diet - Mediterranean
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 celiacdisease, 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 ona 0-to-10-point scale
At least 80 percent compliance in daily questionnaire entries during the 7-dayscreening period
Exclusion
Exclusion Criteria:
Subjects adhering to any dietary IBS treatment such as the low-fodmap diet, orgluten-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 alactose-free diet will not be excluded from the study).
Subjects with a history of poorly controlled insulin-dependent ornon-insulin-dependent diabetes
Subjects with a known history of organic Gastrointestinal (GI) disease (i.e., celiacdisease, inflammatory bowel disease or microscopic colitis)
Subjects with a history of an eating disorder requiring medical or behavioraltreatment within the past 10 years.
Subjects with prior small bowel or colonic surgery (excluding appendectomy orcholecystectomy 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 priorto Screening or during the study.
Currently pregnant or breastfeeding.
Study Design
Connect with a study center
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
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