NCT06240065

Successful Fiber Food Introduction in Short Bowel Syndrome

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 4 Months – 17 Years
• Healthy volunteers: Accepted

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.

Detailed 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 goal of SBS treatment is to achieve enteral autonomy using strategies that optimize intestinal absorption while minimizing unpleasant gastrointestinal (GI) side effects. One strategy that has emerged is the addition of soluble fiber to enteral formula, and this strategy has gained popularity in clinical practice as fiber-rich formulas comprised of blenderized whole foods have become commercially available. However, the investigators' preliminary observations suggest that patients with SBS have variable tolerance and growth outcomes on these blenderized feeds. To date, there are no clinical studies documenting the effects of dietary fiber in SBS patients and guidance in enteral nutrition advancement is lacking in this medically complex population. The current study aims to explore the tolerance of controlled fiber addition to enteral formula based on assessment of GI symptoms, and corresponding changes in microbiome composition, and metabolomics in pediatric patients with SBS versus non-SBS controls. The investigators will use a practical approach with fiber introduction and slowly advance to goal fiber intake to understand the factors leading to continuation. Stool, urine, and plasma samples collected pre- and post- intervention will help identify biomarkers that would predict successful fiber tolerance and optimize selection of patients for fiber introduction. While there is no intent to treat, mitigate, prevent, diagnose or cure the symptoms of SBS, the study may help shed light on the underlying mechanism for intolerance to dietary fiber.

Conditions

• Short Gut Syndrome

Interventions

Type	Name	Description
OTHER	Green bean puree	Green bean puree as a proxy for fiber-foods

Timeline

• Start date: 2024-04-19
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2024-02-02
• Last updated: 2025-11-25

Locations

2 sites across 1 country: United States