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

Not Applicable

Active, not recruiting

• Conditions: IBS - Irritable Bowel Syndrome
• Interventions: Diagnostic Test: Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program

• Registration Number: NCT05178017
• Lead Sponsor: Oxford Biomedical Technologies, Inc.

Brief 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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2022-01-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program	Individuals with Irritable Bowel Syndrome (IBS)

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms severity	3 months	To evaluate gastrointestinal symptoms severity of participants with irritable bowel syndrome from baseline to 12 weeks by using the IBS-Symptom Severity Scale (IBS-SSS). Items relate to gastrointestinal pain, bowel dysfunction, and overall wellbeing will be used to evaluate IBS severity. A higher score indicating worse condition.
The quality of life	3 months	To evaluate the quality of life of participants with irritable bowel syndrome from baseline to 12 weeks using the IBS-36 Quality of Life (IBS-36): The self-administrated IBS-36 questionnaire consists of 36 individual questions. Each question's response is scored on a 7-point Likert scale where 0 = never and 6 = always. A final score is a sum of the scores of the 36 questions. The highest possible score on the IBS-36 is 216, and the lowest is 0.

Trial Locations

Locations (1)

Oxford Biomedical Technologies, Inc.; 🇺🇸 Riviera Beach, Florida, United States