Fiber Food Introduction in Pediatric Short Bowel Syndrome
ConditionShort Gut Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorChildren's Hospital of Philadelphia
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Green bean puree
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Children's Hospital of Philadelphia
Lead sponsor
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov