Ensayos clínicos

Inclusion Criteria:

• 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 diet.
• Well controlled diabetic patients; A1C 3 months, NOT Metformin).
• 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.
• 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.
• A positive IgG antibody response for at least one food in the Biomerica InFoods® IBS panel.

Exclusion Criteria:

• 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 Rome IV Diagnostic Criteria.
• Diagnosed IBS, but an IBS-API score of 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 [e.g., 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 > 6 months.
• 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.