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

Study Overview
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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.

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.

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

Conditions
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IBS - Irritable Bowel Syndrome

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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>Individuals with Irritable Bowel Syndrome (IBS) | Diagnostic Test: Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory blood markers | 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). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms severity | 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. | 3 months | 
| The quality of life | 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. | 3 months |