Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)

Last updated: April 1, 2024
Sponsor: Oxford Biomedical Technologies, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Colic

Treatment

Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program

Clinical Study ID

NCT05178017
Pro00048988
  • Ages 18-75
  • All Genders

Study Summary

A three month follow-up study to evaluate the effectiveness of a tailored anti-inflammatory eating plan guided by a registered dietitian to treat irritable bowel syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients with an established diagnosis of IBS-D as determined by Rome III or IVCriteria
  • Have IBS of at least moderate severity
  • Must be on a stable dose regimen for at least 1 month prior to enrollment
  • Willing to follow the LEAP program for 3 months
  • Able to give informed consent
  • Willing to complete the study

Exclusion

Exclusion Criteria:

  • Individuals with a history of inflammatory bowel disease, celiac disease, abdominalsurgeries, cancer patients under treatment, and kidney failure
  • BMI of 40 or higher
  • Pregnancy or planned pregnancy or lactation
  • Any serious illness that will interfere with the study procedures or results
  • Enrollment in active clinical trial/ experimental therapy within the last 30 days
  • Currently on another dietary treatment approach

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program
Phase:
Study Start date:
September 01, 2021
Estimated Completion Date:
December 31, 2025

Study Description

This study will have 60 participants with Irritable bowel syndrome (IBS) for a duration of three months. The procedures will consist of anthropometric measures, blood pressure, questionnaires, and a blood sample. There will be seven visits with one including a virtual meeting with a registered dietitian involved in the Lifestyle Eating and Performance (LEAP) program. With these procedures the investigators will test the effectiveness of the LEAP program for the treatment of irritable bowel syndrome by improving inflammatory markers, symptoms, and quality of life.

Connect with a study center

  • Oxford Biomedical Technologies, Inc.

    Riviera Beach, Florida 33404
    United States

    Active - Recruiting

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