NCT05432648 · Children's Hospital of Philadelphia
Fiber Food Introduction in Pediatric Short Bowel Syndrome
What this study is about
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.
View original scientific 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 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.
Interventions
DIETARY_SUPPLEMENT
Green bean puree
Green 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.
Primary outcome measures
Symptoms
Time frame: 3 weeks-6 months
To assess the rate of continuation and symptoms/signs leading to discontinuation of fiber addition in SBS vs controls
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- Philadelphia, Pennsylvania
Collaborators
University of Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations