Fiber Food Introduction in Pediatric Short Bowel Syndrome

This study is looking at how well children with short bowel syndrome (SBS) tolerate fiber in their diet compared to children without SBS. Short bowel syndrome is a condition where the small intestine is shorter than usual, making it hard to get enough nutrients. Researchers are using green bean puree, which contains fiber, to see how it affects gastrointestinal (GI) symptoms and changes in gut bacteria (microbiome). The goal is to understand how to best introduce fiber to help children with SBS. This study is currently recruiting children aged 4 months to 18 years who are patients at Children's Hospital of Philadelphia (CHOP) outpatient clinics. Success will be measured by changes in symptoms over 3 weeks to 6 months.

Study design
This is an interventional study planning to enroll 60 participants. It compares children with short bowel syndrome to a control group without intestinal problems.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants' symptoms will be measured for 3 weeks to 6 months after starting the intervention.

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NCT05432648

Fiber Food Introduction in Pediatric Short Bowel Syndrome

Recruiting
NAAges 4–18InterventionalTreatment
Children's Hospital of Philadelphia
~60 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Green bean puree

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Symptoms
Measured over 3 weeks-6 months
Short Gut Syndrome
1 sites across 1 states
Pennsylvania1
  • Lindsey Albenberg, DO · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
  • Christina Bales, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
  • Wenjing Zong, MD · STUDY_DIRECTOR · Children's Hospital of Philadelphia

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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
  • Symptoms3 weeks-6 months

    To assess the rate of continuation and symptoms/signs leading to discontinuation of fiber addition in SBS vs controls