Successful Fiber Food Introduction in Short Bowel Syndrome

NCT06240065 | Enrolling By Invitation

• 1 other identifier: STU-2023-1152
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Short Gut Syndrome

Keywords

nutrition; fiber; sbs; microbiome; metabolome

Outcome Measures

Primary Outcomes (1)

• Clinical tolerance

  To assess the rate of clinical intolerance leading to discontinuation of green beans and symptoms/signs associated with discontinuation of fiber addition in SBS vs controls (no score/scale will be used)

  3 weeks-6 months

Secondary Outcomes (1)

• Microbiome/Metabolome Analysis

  3 weeks-6 months

Study Arms (2)

Short Bowel Syndrome Arm

EXPERIMENTAL

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.

Other: Green bean puree

Control Arm

ACTIVE COMPARATOR

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.

Other: Green bean puree

Interventions

Green bean puree OTHER

Green bean puree as a proxy for fiber-foods

Control Arm; Short Bowel Syndrome Arm

Eligibility Criteria

• Age: 4 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify 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 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (2)

Children's Medical Center

Dallas, Texas, 75390, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Short Bowel Syndrome; MYH9-Related Disorders

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenjing Zong, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Pediatric Gastroenterology

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: April 19, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (2)