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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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IBS - Irritable Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants

Individuals with Irritable Bowel Syndrome (IBS)

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No