Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)
Effectiveness of the Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
January 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 25, 2025
May 1, 2025
5.3 years
October 25, 2021
May 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Gastrointestinal symptoms severity
3 months
The quality of life
3 months
Study Arms (1)
Participants
EXPERIMENTALIndividuals with Irritable Bowel Syndrome (IBS)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oxford Biomedical Technologies, Inc.
Riviera Beach, Florida, 33404, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gustavo Zarini, Ph.D., RD
Oxford Biomedical Technologies, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2021
First Posted
January 5, 2022
Study Start
September 1, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 25, 2025
Record last verified: 2025-05