Introducing fiber foods to children with short bowel syndrome
Official title: Clinical Tolerance and Microbiome Changes Following Fiber Food Introduction in Short Bowel Syndrome
Run by Children's Hospital of Philadelphia · NCT05432648 · Data updated 2026-11-12
This study is testing how well children with short bowel syndrome can handle fiber foods, like green bean puree, to see if it helps improve their nutrition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Months to 18 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | May 8, 2022 |
| Main results expected | August 30, 2027 |
| Study ends | October 2027 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT05432648 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pediatric patients diagnosed with short bowel syndrome who are actively followed at the Children's Hospital of Philadelphia.
✕Probably not a fit
Patients with a history of intestinal pathologies other than short bowel syndrome may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the tolerance of dietary fiber in pediatric patients with short bowel syndrome (SBS) compared to those without the condition. It focuses on assessing gastrointestinal symptoms and changes in microbiome composition and metabolomics as fiber is gradually introduced into their diet. The intervention involves the use of green bean puree as a source of soluble fiber, with careful monitoring of the participants' responses. The study seeks to provide insights into how fiber can be integrated into the diets of children with SBS to improve their nutritional outcomes.
Why it matters
Potential benefit: If successful, this study could enhance dietary management for children with short bowel syndrome, potentially leading to improved nutritional absorption and quality of life.
How similar studies have gone: While there is limited clinical research specifically on fiber in SBS patients, the approach of using dietary interventions has shown promise in related gastrointestinal conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Actively follows at the Children's Hospital of Philadelphia (CHOP) outpatient clinics * SBS arm specific: History of SBS diagnosis. History of short bowel syndrome based on surgical/imaging records. Small bowel is in continuity with some portion of colon * Control arm specific: No history of intestinal pathologies * No or negligible amount (few bites of fiber-containing foods okay) of fiber in tube feeds or by mouth at baseline * Less than 20% calories from oral food not containing fiber while the other 80% may be by enteral and/or parenteral feedings * At least 20% calories from fiber-free formula taken orally or via tube * Antibiotic use is allowed, however, should be on a stable regimen of antibiotics starting from 2 weeks prior to intervention until end of study or end of week 3 whichever is sooner. Instances of antibiotic use for brief courses (7-10 days) as long as sample collection is scheduled to be at least a week from the end date of antibiotics. * Previous history of fiber introduction failure is acceptable as long as clinically stable at the time of recruitment * Fiber supplementation is appropriate per primary physician * If subject is unable to provide full set of samples, they will still be enrolled Exclusion Criteria: * SBS Arm specific: No diagnosis of SBS. * Control Arm specific: has baseline intestinal diseases * Small bowel and colon not in continuity (Ex: presence of ileostomy or jejunostomy) * \>5% changes in percentage of calories from oral nutrition (PO), enteral nutrition (EN) and/or parenteral nutrition (PN) during the intervention * Addition/discontinuation/significant alteration to antibiotics regimen during study period * Primary physician does not think fiber supplementation is appropriate clinically
Where it's running
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Lindsey Albenberg, DO — Children's Hospital of Philadelphia
- Study coordinator: Lindsey Albenberg, DO
- Email: albenbergl@chop.edu
- Phone: 2674260139
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Crofelemer for adults with short bowel syndrome and intestinal failure without a colon
This trial will test whether taking crofelemer three times a day helps adults with short bowel syndrome and intestinal failure who lack a colon and need parenteral support.
-
LpD3.5 Intervention for Gut Health and Cognition in Older Adults with MCI
In older adults with mild cognitive impairment, this study tests whether daily LpD3.5 capsules can improve gut health and potentially cognition compared with placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.