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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Green bean puree
Dietary supplementGreen bean contains both soluble and insoluble fiber, which may have different extent of influence on the gut microbiome. Using a real food rather than a purified fiber such as pectin is more practical and more acceptable to families.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Short Bowel Syndrome ArmExperimental treatment 1 intervention
Group B: Control Arm -Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Symptoms
To assess the rate of continuation and symptoms/signs leading to discontinuation of fiber addition in SBS vs controls
Time frame
3 weeks-6 monthsSecondary outcomes
1
Microbiome/Metabolome Changes
To correlate changes in clinical status on fiber to microbiome/metabolome changes in SBS vs controls
Time frame
3 weeks-6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov