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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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Diet and lifestyle changes are the recommended first line treatments for symptom relief in irritable bowel syndrome (IBS). Currently the only diet that is widely recommended and for which there is good evidence of efficacy in IBS is one low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low-FODMAP). While effective, the Low-FODMAP diet is burdensome and costly to patients and in clinical practice adherence to FODMAP restriction is less than optimal. Further, patients who respond to a FODMAP restriction often are reluctant to reintroduce more FODMAPs into their diet, which may deprive them of foods, particularly fruits and vegetables with important health benefits. Therefore, there is a need for other dietary interventions for IBS that are less burdensome to patients. This clinical trial assesses the efficacy of two dietary interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet A | Experimental | Modified Diet A |
|
| Diet B | Experimental | Modified Diet B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet A | Other | Modified Diet A |
| |
| Diet B |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal Pain Intensity | Proportion of weekly responders. A weekly responder is defined as a decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal Discomfort Intensity | Proportion of weekly responders. A weekly responder is defined as a decrease in worst abdominal discomfort in the past 24 hours score of at least 30% compared with baseline. | 28 days |
| Composite Score |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johanna Iturrino Moreda, MD | Contact | 6176672138 | jiturrin@bidmc.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38729393 | Derived | Singh P, Chey SW, Nee J, Eswaran S; Dietary Therapy in IBS Working Group; Lembo A, Chey WD. Is a Simplified, Less Restrictive Low FODMAP Diet Possible? Results From a Double-Blind, Pilot Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2025 Feb;23(2):362-364.e2. doi: 10.1016/j.cgh.2024.04.021. Epub 2024 May 9. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Other |
Modified Diet B |
|
Proportion of weekly composite responders. A weekly composite responder is defined as a subject who experiences a decrease in the weekly average of worst abdominal pain in the 24 hours score of at least 30% compared with baseline AND who experiences a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline
| 28 days |
| Abdominal Bloating Intensity | Proportion of weekly responders. A weekly responder is defined as a decrease in worst abdominal bloating in the past 24 hours score of at least 30% compared with baseline. | 28 days |
| Stool Consistency | Weekly responder. A weekly responder is defined as a decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Bristol Stool Form Scale Type 6 or Type 7 compared with baseline. | 28 days |
| Irritable Bowel Syndrome - Symptom Severity Score | Proportion of subjects who experience a 50-point and 100-point decrease in IBS-SSS compared with baseline. | 28 days |
| Irritable Bowel Syndrome - Symptom Severity Score | Change in IBS-SSS as compared with baseline. | 28 days |
| Adequate Relief | Proportion of subjects who experience adequate relief compared with baseline. | 28 days |
| University of Michigan - Ann Arbor | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| D004066 | Digestive System Diseases |