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
Among 344 studies in Irritable Bowel Syndrome with a site in United States — 45 open to participants now, 49 under way, 3 of them phase 3. Irritable Bowel Syndrome · United States.
Among the 344 studies in Irritable Bowel Syndrome with a site in United States, this one is the 25th largest by enrollment of the 287 interventional ones that give a count, is one of 18 that started in 2018, is one of 134 with no phase, and was the 211th registered.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
Browse Irritable Bowel Syndrome studies →45 of the 344 studies in Irritable Bowel Syndrome with a site in United States are open now. Recruiting first, the newest first:
Baylor College of Medicine · Sites in United States
University of Michigan · Sites in United States
Eli Lilly and Company · Sites in United States, Belgium, Canada and 7 more countries
Kiwi Health Inc · Sites in United States
Eli Lilly and Company · Sites in United States, Belgium, Canada and 5 more countries
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 126 Irritable Bowel Syndrome studies recruiting now, 33 (26%) set no upper age limit and 83 (66%) stop at 75 or younger; 18 take children under 18; 28 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
344 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 91 · Phase 3 38 · Phase 4 15
First in 1996; this study’s year is marked. 18 started in 2018.
This study's enrollment of 556 is above the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Median enrollment 61 across the 287 interventional studies, 150 across the 55 observational. Of the 274 that completed or were terminated, 104 (38%) have results posted.
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119 of 344 have an industry lead sponsor. The 10 most frequent:
Biomerica is the lead sponsor of 3 studies on the registry; none are open to participants now.
Biomerica has 1 study filed under Irritable Bowel Syndrome — fewer than ten, so there is no comparison to draw.
24 of the studies in Irritable Bowel Syndrome with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05519683Phase 3University of MichiganHome Transcutaneous Electrical Acustimulation (TEA) | 2027-03 |
| NCT04506593Indiana UniversityIndiana University Gastrointestinal Motility Diagnosis Registry | 2026-11 |
| NCT06760533NYU Langone HealthPsilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS) | 2026-12 |
| NCT06288672IBS-80, LLCIBS Skin Patch Test Food Allergy Study | 2026-12 |
| NCT06684470Mayo ClinicNovel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator | 2026-12-19 |
Among the 344 studies in Irritable Bowel Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Gastroparesis, Uncontrolled GERD, Anorexia/bulimia Celiac disease Crohn's disease, Ulcerative Colitis, Abdominal/gastro cancer(s), Malabsorption syndrome(s).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Ran from Jun 2018 to primary completion in Dec 2021, 42 months.
Of 52 industry-sponsored interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's 42 months is above that.
Counting every sponsor, half of 357 studies reached it within 19 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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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