Fiber Food Introduction in Pediatric Short Bowel Syndrome

NCT05432648 | Active Not Recruiting

• 1 other identifier: 21-019185
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 short bowel syndrome compared to patients without short bowel syndrome based on assessment of gastrointestinal symptoms, and corresponding changes in microbiome composition and metabolomics.

Conditions

Short Gut Syndrome

Outcome Measures

Primary Outcomes (1)

• Symptoms

  To assess the rate of continuation and symptoms/signs leading to discontinuation of fiber addition in SBS vs controls

  3 weeks-6 months

Secondary Outcomes (1)

• Microbiome/Metabolome Changes

  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.

Dietary Supplement: 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.

Dietary Supplement: Green bean puree

Interventions

Green bean puree DIETARY_SUPPLEMENT

Green bean contains both soluble and insoluble fiber, which may have different extent of influence on the gut microbiome. Using a real food rather than a purified fiber such as pectin is more practical and more acceptable to families.

Control Arm -; Short Bowel Syndrome Arm

Eligibility Criteria

• Age: 4 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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 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 courses (7-10 days) as long as sample collection is scheduled to be at least a week from the end date of antibiotics.
• 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

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 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Lindsey Albenberg, DO

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Christina Bales, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Wenjing Zong, MD

  Children's Hospital of Philadelphia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: May 8, 2022
• Primary Completion: June 30, 2025
• Study Completion: May 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)