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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Experimental | Individuals with Irritable Bowel Syndrome (IBS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gustavo Zarini, Ph.D., RD | Oxford Biomedical Technologies, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Biomedical Technologies, Inc. | Riviera Beach | Florida | 33404 | United States |
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| 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 |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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