NCT05432648 Fiber Food Introduction in Pediatric Short Bowel Syndrome
| NCT ID | NCT05432648 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Short Gut Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-05-08 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-05-08 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Short bowel syndrome (SBS) is a rare but challenging condition in which patients have insufficient bowel length to meet fluid, electrolyte, and nutrient requirements without parenteral support. The purpose of this study is to determine how well dietary fiber is tolerated in patients with short bowel syndrome compared to patients without short bowel syndrome based on assessment of gastrointestinal symptoms, and corresponding changes in microbiome composition and metabolomics.
Eligibility 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
Contact & Investigator
Lindsey Albenberg, DO
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT05432648 clinical trial?
This trial is open to participants of all sexes, aged 4 Months or older, up to 18 Years, studying Short Gut Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05432648 currently recruiting?
Yes, NCT05432648 is actively recruiting participants. Contact the research team at albenbergl@chop.edu for enrollment information.
Where is the NCT05432648 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05432648 clinical trial?
NCT05432648 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Lindsey Albenberg, DO at Children's Hospital of Philadelphia. The trial plans to enroll 60 participants.