Status:
COMPLETED
Endpoint Determination Study Protocol
Lead Sponsor:
Biomerica
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This study is designed to evaluate the most applicable endpoints for evaluation of the Biomerica InFoods® IBS product.
Detailed Description
The objective of this Endpoint Determination Study is to address key elements regarding a proposed larger clinical study design: 1. Comparing different potential primary outcome measures 2. Demonstra...
Eligibility Criteria
Inclusion
- 21 years old or older.
- Able to read and understand English.
- Willing and able to sign the informed consent.
- Have access to a computer and/or cell phone access for Electronic Data Capture (EDC)
- Meets Rome IV Diagnostic Criteria for IBS
- Willing to follow a food elimination die
- Well controlled diabetic patients; A1C \<7.5 and stable medication (\>3 months, NOT Metformin
- Score between ≥ 3 and \<7.5 on the Abdominal Pain Intensity Assessment (IBS\_API) based on a weekly average of worst daily (in past 24 hours) abdominal pain on a 0 to 10 point scale.
- Patients who are on stable (\> 3 months) doses of medications or treatments for their IBS (e.g., probiotics, fiber, Viberzi, Linzess, Amitiza, Alosetron, Plecanatide, anticholinergics, antidepressants, Zofran bile acid sequestrants, or anti-diarrheals) will be allowed to continue their medications as long as no change in treatment is planned for the duration of the study and no dose adjustment is made during the duration of the study.
- A positive IgG antibody response for at least one food in the Biomerica InFoods® IBS panel
Exclusion
- Unable to provide consent.
- Cannot use EDC system due to no cell phone and no computer access
- Does not qualify for a diagnosis of IBS by IV Diagnostic Criteria
- Diagnosed IBS, but an IBS-API score of \<3.0 and \>7.5
- Pregnant or breastfeeding
- Patients with diabetes currently on Metformin
- Patients who have used Rifaximin in the past 3 months
- Patients engaged in another type of diet therapy, i.e. FODMAP
- Patients which physicians are anticipating starting a new medication, change in dosage, diet or other treatment for IBS during the study
- Chronic pain from other conditions besides IBS
- Current or previous use of narcotic medications within past 3 months
- History of prior GI surgery except for cholecystectomy or appendectomy.
- History with any of the following:
- Gastroparesis, Uncontrolled GERD, Anorexia/bulimia Celiac disease Crohn's disease, Ulcerative Colitis, Abdominal/gastro cancer(s), Malabsorption syndrome(s).
- History of any other relevant inter-current medical conditions that could interfere with their participation in the study or the objectives of the study
- History of psychosis, schizophrenia, mania, or major psychiatric illness needing hospitalization within the past 6 months
Key Trial Info
Start Date :
June 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
556 Patients enrolled
Trial Details
Trial ID
NCT03459482
Start Date
June 21 2018
End Date
December 31 2021
Last Update
August 5 2024
Active Locations (8)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
3
Family Medicine Specialists
Wauconda, Illinois, United States, 60084
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215