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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK101688 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study evaluates whether the gut microbiome is involved in determining whether children with irritable bowel syndrome (IBS) develop worsening GI symptoms (e.g. pain) when given fructans (a sugar often found in wheat). Participants will both receive a diet with fructans and a diet without fructans.
Fructans (fructo-oligosaccharides) are a type of carbohydrate which can not be hydrolyzed by humans. It is commonly found in wheat in the American diet. After ingestion they arrive essentially intact into the colon where they are metabolized by the colonic microbiome. Fructan avoidance has been found to help decrease gastrointestinal symptoms (e.g. pain) in those with IBS.
However not all individuals with IBS have worsening symptoms when eating fructans in their diet. This study seeks to evaluate whether the microbiome is involved in determining whether an individual with IBS has worsening symptoms with fructan ingestion.
Following a one week baseline period, participants will be randomized in a double-blind cross-over fashion to either a 72 hour meal period with fructans or a 72 hour meal period with maltodextrin (placebo). A washout period of at least 10 days will occur in between. Symptoms will be captured using a stool and pain diary. Stool specimens and urine specimens will be obtained at baseline and during the dietary interventions. Breath hydrogen testing will be obtained during the dietary interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fructan | Active Comparator | Fructans will be provided for 72 hours. |
|
| Maltodextrin | Placebo Comparator | Maltodextrin will be provided for 72 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fructan | Other | Short-chain oligosaccharide primarily composed of fructose polymers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operational Taxonomic Units (microbiome composition derived from 16s rRNA sequencing) | Children with IBS who have worsening GI symptoms with fructans vs. those who do not | Three days |
| Microbiome metabolic signatures related to fructan metabolism | Children with IBS who have worsening GI symptoms with fructans vs. those who do not | Three days |
| Metabolic products of fructan metabolism | In those with IBS who have worsening symptoms when given fructans, the investigators will correlate fructan metabolic byproducts with GI symptoms (e.g. pain) | Three days |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome related signatures | Healthy children will have their microbiome signatures (composition, metabolic signatures related to fructan metabolism, and metabolic products of fructan metabolism) compared to children with IBS | Three days |
| Overall microbiome metabolic signatures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Chumpitazi, MD, MPH | Assistant Professor | 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 |
|---|---|---|---|
| 28970147 | Derived | Chumpitazi BP, McMeans AR, Vaughan A, Ali A, Orlando S, Elsaadi A, Shulman RJ. Fructans Exacerbate Symptoms in a Subset of Children With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2018 Feb;16(2):219-225.e1. doi: 10.1016/j.cgh.2017.09.043. Epub 2017 Sep 29. |
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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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| ID | Term |
|---|---|
| D005630 | Fructans |
| C116580 | fructooligosaccharide |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Maltodextrin | Other | Polysaccharide produced from starch |
|
Children with IBS who have worsening GI symptoms vs. those who do not |
| Three days |
| Overall metabolic products | Following a fructan challenge in children with IBS who develop worsening GI symptoms vs. those who do not | Three days |
| Breath hydrogen and methane production symptoms | Children with IBS who have worsening GI symptoms when given fructans vs. those who do not | Three days |
| Houston |
| Texas |
| 77030 |
| United States |
| D004066 | Digestive System Diseases |