Endpoint Determination Study Protocol

Overview

Información sobre este estudio

The purpose of this study is to evaluate the most applicable endpoints for evaluation of the Biomerica InFoods® IBS product.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • 21 years old or older.
  • Able to read and understand English.
  • Have access to a computer and/or cell phone access for Electronic Data Capture (EDC).
  • Meets Rome III or Rome IV Diagnostic Criteria for IBS -Respond "No" to IBS Adequate Relief (IBS-AR) in the past week at the screening Visit #1.
  • 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.
  • 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.
  • Willing to follow a food elimination diet.

Exclusion Criteria:

  • Cannot use EDC system due to no cell phone and no computer access.
  • Unable to provide consent.
  • Pregnant or breastfeeding.
  • Does not qualify for a diagnosis of IBS by Rome III or IV Diagnostic Criteria.
  • Diagnosed IBS, but an IBS-API score of < 3.0 and > 7.5.
  • 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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Brian Lacy, M.D., Ph.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20488751

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