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Status:

ACTIVE_NOT_RECRUITING

Fiber Food Introduction in Pediatric Short Bowel Syndrome

Lead Sponsor:

Children's Hospital of Philadelphia

Collaborating Sponsors:

University of Pennsylvania

Conditions:

Short Gut Syndrome

Eligibility:

All Genders

4-18 years

Phase:

NA

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 p...

Detailed Description

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 go...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 8 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05432648

Start Date

May 8 2022

End Date

May 1 2026

Last Update

August 17 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104