Successful Fiber Food Introduction in Short Bowel Syndrome

Enrolling by invitation · Not applicable

Conditions studied: Short Gut Syndrome

In brief

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 or without short bowel syndrome based on assessment of gastrointestinal symptoms, weight, and corresponding changes in microbiome composition and metabolomics.

Key facts

Study ID: NCT06240065
Run by: University of Texas Southwestern Medical Center
People needed: 60
Starts: 2024-04-19
Expected to finish: 2028-04-01
Last updated by the study team: 2025-11-25

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Actively follows at UTSW 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
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

You may not qualify if…

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 PO, EN and/or 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 it is running

Children's Medical Center — Dallas, Texas, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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