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New treatment option for Short Gut Syndrome
Official title Fiber Food Introduction in Pediatric Short Bowel Syndrome
ClinicalTrials.gov ID: NCT05432648
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 18. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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
You likely can't join 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 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 months to 18 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.