Successful Fiber Food Introduction in Short Bowel Syndrome

NCT ID: NCT06240065

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-19
• Study Completion Date: 2028-04-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short Bowel Syndrome Arm

Patients with SBS will be initiated on green bean purees added to enteral formula recipes, based on kilocalories of enteral formula over 3 weeks. During week 1 subjects will prepare and add 50 mL green bean puree per 1000kcal of enteral feed (5%) to their formula mixture, increasing to 100ml (10%) and 150ml (15%) during weeks 2 and 3, respectively.

Group Type: EXPERIMENTAL

Green bean puree

Intervention Type: OTHER

Green bean puree as a proxy for fiber-foods

Control Arm

Patients without SBS will be initiated on green bean purees added to enteral formula recipes, based on kilocalories of enteral formula over 3 weeks. During week 1 subjects will prepare and add 50 mL green bean puree per 1000kcal of enteral feed (5%) to their formula mixture, increasing to 100ml (10%) and 150ml (15%) during weeks 2 and 3, respectively.

Group Type: ACTIVE_COMPARATOR

Green bean puree

Intervention Type: OTHER

Green bean puree as a proxy for fiber-foods

Interventions

Green bean puree

Green bean puree as a proxy for fiber-foods

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Wenjing Zong

Assistant Professor in Pediatric Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenjing Zong, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Children's Medical Center

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2023-1152

Identifier Type: -

Identifier Source: org_study_id