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

IBS - Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05178017
• Other study ID #: Pro00048988
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Oxford Biomedical Technologies, Inc.
• Contact: Gustavo Zarini, Ph.D., RD
• Phone: 888-669-5327
• Email: Dr.GZarini[@]nowleap.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Oxford Biomedical Technologies, Inc.	Riviera Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Oxford Biomedical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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