Successful Fiber Food Introduction in Short Bowel Syndrome (NCT06240065) | Clinical Trial Compass
By InvitationNot Applicable
Successful Fiber Food Introduction in Short Bowel Syndrome
United States60 participantsStarted 2024-04-19
Plain-language summary
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.
Who can participate
Age range4 Months – 17 Years
SexALL
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Inclusion Criteria:
* 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
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 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
What they're measuring
1
Clinical tolerance
Timeframe: 3 weeks-6 months
Trial details
NCT IDNCT06240065
SponsorUniversity of Texas Southwestern Medical Center