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

NCT05178017 · tracked via the Priya Life Science USA tracker

Sponsor

Oxford Biomedical Technologies, Inc.

Phase

Not applicable

Started

2021-09-01

Last updated

2025-05-25

Condition(s) studied

IBS - Irritable Bowel Syndrome

Investigational drug(s) / intervention(s)

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

Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program: The LEAP program is based on the in-vitro Leukocyte Activation Assay (LAA-MRT) results and initially prepared with the least immune reactive foods and chemicals, and subsequent foods will be added depending on the degree of immune reactivity in a nutritionally balanced manner.

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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Adult patients with an established diagnosis of IBS-D as determined by Rome III or IV Criteria * 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 Criteria: * Individuals with a history of inflammatory bowel disease, celiac disease, abdominal surgeries, 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

Primary outcome measure(s)

Inflammatory blood markers — 3 months
To evaluate the cytokines levels (IL-I b; IL-6; IL-8; IL-10; IL-12; IL-17; TNF-a) of participants with irritable bowel syndrome from baseline levels to 12 weeks by using a Bio-Plex 200 System (Bio-Rad, California, USA).

Trial sites (1)

Facility	City	Region	Status
Oxford Biomedical Technologies, Inc.	Riviera Beach	Florida

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05178017 on ClinicalTrials.gov ↗ ← All trials in the USA