Fiber Food Introduction in Pediatric Short Bowel Syndrome

Recruiting now · Not applicable

Conditions studied: Short Gut Syndrome

In brief

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.

Key facts

Study ID

NCT05432648

Run by

Children's Hospital of Philadelphia

People needed

60

Starts

2022-05-08

Expected to finish

2027-10-01

Last updated by the study team

2026-07-10

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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