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NCT Number: NCT05178017

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

IBS - Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oxford Biomedical Technologies, Inc.

Riviera Beach, Florida, 33404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Inflammatory blood markers

    Time frame: 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 outcomes

  1. Gastrointestinal symptoms severity

    Time frame: 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.

  2. The quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oxford Biomedical Technologies, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2022
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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