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

Oxford Biomedical Technologies

Status: Active, not recruiting

Conditions: IBS - Irritable Bowel Syndrome

Treatments: Diagnostic Test: Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program

Study type: Interventional

Funder types: Industry

Identifiers

NCT05178017

Pro00048988

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Participants

Experimental group

Description:

Individuals with Irritable Bowel Syndrome (IBS)

Treatment:

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