An interventional study of Food Elimination Diet in Irritable Bowel Syndrome, sponsored by Biomerica. Completed at 8 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-08-05.
Sponsored by Biomerica · Not applicable, Interventional, and Treatment
This study is designed to evaluate the most applicable endpoints for evaluation of the Biomerica InFoods® IBS product.
The objective of this Endpoint Determination Study is to address key elements regarding a proposed larger clinical study design:
Subjects' diets will be based on the results of the Biomerica, InFoods® IBS Test.
Immunoglobulin G (IgG) levels above a certain threshold are considered a positive response against a specific food or foods. It is expected that severity of symptoms of IBS will decrease when foods that generate a positive immune response in the Biomerica InFoods® IBS test are eliminated from the diet of the IBS patient.
The Endpoint Determination Study format will be a double-blinded randomized controlled clinical study enrolling subjects at two trial sites within the United States and designed to evaluate the use of IgG antibody guided dietary restrictions, based on the Biomerica InFoods® IBS Test, in the management of patients diagnosed with Irritable Bowel Syndrome (IBS).
The 2 sites will enroll approximately equal numbers of subjects. The target for each site is a minimum of 30 subjects in each classification: IBS with diarrhea [IBS-D], IBS with constipation [IBS-C] and IBS mixed [IBS-M] for a minimum of 90 patients per site, 180 total subjects for this study.
Exclusion Criteria:
Gastroparesis, Uncontrolled GERD, Anorexia/bulimia Celiac disease Crohn's disease, Ulcerative Colitis, Abdominal/gastro cancer(s), Malabsorption syndrome(s).
Group 1 (experimental group): Subjects will be given an elimination diet based upon foods with a positive antibody profile in the Biomerica InFoods® IBS test. The elimination diet will also exclude any and all foods to which the subject has a known IgE allergy and foods the subject already currently eliminates.
Other: Food Elimination Diet
Group 2 (control group): Subjects will be given a "Sham" elimination diet. The sham diet will eliminate the same number of foods but none of the actual foods to which the patient had a positive antibody profile in the Biomerica InFoods® IBS test. The sham diet will also eliminate any and all foods to which the subject has a known IgE allergy and foods the subject already currently eliminates.
Other: Food Elimination Diet
Subjects asked to participate in a food elimination diet, either True or Sham to evaluate the effects on their IBS symptoms
Change in the IBS-API - Abdominal Pain Intensity. The IBS-API is being assessed daily from enrollment (baseline) to study completion; total 10 weeks
Abdominal pain intensity will be measured daily using an 11-point (0-10) numeric rating scale (NRS) that asks subjects to rate their worst abdominal pain over the past 24-hours.
Time frame: Daily for 10 weeks
Plan to share: No — It is not yet known if there will be a plan to make IPD available.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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