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

Primary Purpose

IBS - Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program
Sponsored by
Oxford Biomedical Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IBS - Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oxford Biomedical Technologies, Inc.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

Individuals with Irritable Bowel Syndrome (IBS)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 25, 2021
Last Updated
March 22, 2023
Sponsor
Oxford Biomedical Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05178017
Brief Title
Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)
Official Title
Effectiveness of the Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxford Biomedical Technologies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Arm Description
Individuals with Irritable Bowel Syndrome (IBS)
Intervention Type
Diagnostic Test
Intervention Name(s)
Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program
Intervention Description
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 Outcome Measure Information:
Title
Inflammatory blood markers
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Gastrointestinal symptoms severity
Description
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.
Time Frame
3 months
Title
The quality of life
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gustavo Zarini, Ph.D., RD
Phone
888-669-5327
Ext
722
Email
Dr.GZarini@nowleap.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A McLean, Ph.D
Phone
561-8487111
Ext
703
Email
dr.mclean@nowleap.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Zarini, Ph.D., RD
Organizational Affiliation
Oxford Biomedical Technologies, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Biomedical Technologies, Inc.
City
Riviera Beach
State/Province
Florida
ZIP/Postal Code
33404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo Zarini, Ph.D., RD
Phone
888-669-5327
Ext
722
Email
Dr.GZarini@nowleap.com

12. IPD Sharing Statement

Learn more about this trial

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

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