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)
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Oxford Biomedical Technologies, Inc. | Riviera Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Oxford Biomedical Technologies, Inc. |
United States,
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 |
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