NCT05178017

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Oxford Biomedical Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• IBS - Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2021-09-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-01-05
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study