Defining Objective Markers of Compliance for Dietary Therapies in IBS
ConditionIrritable Bowel Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Michigan
About this trial
This research will investigate if a specific marker in your stool or urine can be used to track changes in your carbohydrate intake including fructo-oligosaccharide and mannitol intake
Eligibility criteria
Qualifiers
Patients with IBS ( including diarrhea, mixed or constipation type) and without unexplained alarm features (rectal bleeding, weight loss, nocturnal pain, nocturnal diarrhea). In presence of alarm symptoms, if they have had evaluation with colonoscopy or fecal calprotectin or serum C-reactive protein (CRP) since onset of alarm symptoms with normal results, they will be included.
Aged 18-65 years at the time of screening
IBS-SSS of at least 175 at baseline
Disqualifiers
Subjects adhering to a dietary treatment such as the low-fat diet, low FODMAP diet, or gluten-free diet, within the past 6 months. Those who are lactose intolerant will not be excluded from the study and will be allowed to limit lactose intake as previously.
Subjects who are predicted to make changes to their baseline IBS medication(s), over-the-counter (OTC) therapy, exercise, diet (beyond what is advised), or initiate/make changes to other complementary therapy that could affect IBS symptoms (e.g. yoga, acupuncture, etc.) during the four weeks study period.
Subjects with a known history of 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.
Trial design
Treatments tested in this trial
- Diet A - elimination diet
- Diet B - healthy eating diet
Treatment groups
94 Participants
are divided into 2 treatment groupsLocations
1University of Michigan48109, Ann ArborMichigan, United States
Sponsors and collaborators
University of Michigan
Lead sponsor
Source ClinicalTrials.gov