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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this clinical trial is to learn if a fiber (psyllium) can change the way bacteria use fructans (a type of sugar) and whether psyllium can help decrease childhood irritable bowel syndrome (IBS) symptoms when eating fructans. The main questions it aims to answer are:
Aim 1: The effect of psyllium at two doses given with a fructan meal on microbial fructan fermentation (intracolonic pH; H2 gas production; gut microbiome composition; fecal short-chain fatty acids, lactate, glycomics).
Aim 2: Determine the impact of psyllium given with a fructan meal on fructan-induced GI symptoms.
Participants will first be asked to eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms. Those with worsening symptoms with fructans will be asked to participate in the second part of the study. This includes two weeks of baseline (no change in diet) and two weeks of eating a specific diet with fructans with either psyllium or glucose. Participants will be asked to complete pain and stool diaries, submit stool specimens, swallow a pill to capture gut acid levels, and give breath samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psyllium (0.7 g/year of age per day) given with fructans | Active Comparator | Participants will receive Psyllium (0.7 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams) |
|
| Psyllium (0.5 g/year of age per day) given with fructans | Active Comparator | Participants will receive Psyllium (0.5 g/year of age per day) given with fructans (daily dose 0.5 g/kg up to 19 grams) |
|
| Placebo (0.7 g/year of age glucose) given with fructans | Placebo Comparator | Participants will receive Placebo (0.7 g/year of age glucose) given with fructans (daily dose 0.5 g/kg up to 19 grams). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psyllium (0.7 g/year of age per day) | Drug | Psyllium (0.7 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbiome composition measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing | Baseline, 2 weeks | |
| Change in fecal lactate | Baseline, 2 weeks | |
| Change in fecal short-chain fatty acids | Baseline, 2 weeks | |
| Change in hydrogen gas production | Baseline, 2 weeks | |
| Change in fecal fructans | Baseline, 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in abdominal pain frequency | Baseline, 2 weeks | |
| Change in abdominal pain severity | Participants will rate abdominal pain on a scale of 0-10, with higher scores indicating more severe pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Chumpitazi, MD, MPH | Contact | 919-660-1227 | bruno.chumpitazi@duke.edu | |
| Annette Babu | Contact | 919-660-1227 | annette.babu@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Chumpitazi, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Recruiting | Durham | North Carolina | 27705 | United States |
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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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| ID | Term |
|---|---|
| D011620 | Psyllium |
| D005630 | Fructans |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Psyllium (0.5 g/year of age per day) | Drug | Psyllium (0.5 g/year of age per day) (Konsyl Pharmaceuticals, Easton, MD) |
|
| Placebo | Drug | Placebo (0.7 g/year of age glucose) (Staleydex 333; Tate & Lyle, Staley, London, UK) |
|
| fructans | Other | Daily dose 0.5 g/kg up to 19 grams, Orafti Synergy1 |
|
| Baseline, 2 weeks |
| Change in bloating severity | Participants will rate bloating on a scale of 0-10, with higher scores indicating worse bloating. | Baseline, 2 weeks |
| Change in flatulence severity | Participants will rate flatulence on a scale of 0-10, with higher scores indicating worse flatulence. | Baseline, 2 weeks |
| D004066 | Digestive System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |