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 range
4 Months – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical tolerance
Timeframe: 3 weeks-6 months
Trial details
NCT IDNCT06240065
SponsorUniversity of Texas Southwestern Medical Center