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| Name | Class |
|---|---|
| NASPGHAN Foundation | OTHER_GOV |
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The purpose of this study is to determine whether a specific diet may help children with irritable bowel syndrome.
Many children experience stomach pain or discomfort at some point during their lives. Some children have belly discomfort frequently while others rarely have this problem. There have been very few studies to test treatments for recurrent stomach discomfort in children. Recently, studies in adults with recurrent stomach discomfort suggest that diet changes may help. Currently, we do not know if these same diets will work in children with the same problem.
In this study, two different diets will be provided (delivered) for two days with at least 5 days in between each provided diet. The child's symptoms will be recorded over the two days of each diet. Children will be asked to capture samples of their breath during the last day of the each two day delivered diet. Stool samples will also be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High fermentable substrate diet | Experimental | High fermentable substrate diet provided for two days |
|
| Low fermentable substrate diet | Experimental | Low fermentable substrate diet provided for two days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low fermentable substrate diet | Other | Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average daily abdominal pain frequency | Comparisons of abdominal pain frequency (number of abdominal pain episodes per day) will be made between each two day dietary period spanning a 9 days. | 9 days (2 dietary intervention periods) |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal pain severity | The severity of abdominal pain episodes will be measured on a 1-10 (10 being most severe) ordinal scale. Average severity per abdominal pain episode during each two day dietary period will be compared over 9 days. | 9 days (2 dietary intervention periods) |
| Hydrogen gas production |
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Inclusion Criteria:
Must include all of the following:
Exclusion Criteria:
Will include any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno P Chumpitazi, MD, MPH | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Nutrition Research Center | Houston | Texas | 77030 | United States | ||
| Texas Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26104013 | Derived | Chumpitazi BP, Cope JL, Hollister EB, Tsai CM, McMeans AR, Luna RA, Versalovic J, Shulman RJ. Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome. Aliment Pharmacol Ther. 2015 Aug;42(4):418-27. doi: 10.1111/apt.13286. Epub 2015 Jun 24. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| High fermentable substrate diet | Other | Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols |
|
Daily hydrogen gas production (parts per million) will be compared between each 2 day dietary intervention period over 9 days. |
| 9 days (2 dietary intervention periods) |
| Houston |
| Texas |
| 77030 |
| United States |
| D004066 | Digestive System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |