Recruiting

Fiber FoodFiber Food Introduction in Pediatric Short Bowel Syndrome

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT05432648

Conditions

Short Gut Syndrome

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Interventions

Green bean puree

Study Details

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

Study ID

NCT05432648

Start date

May 8, 2022

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Accepted

Inclusion 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 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

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 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

Green bean puree

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.

Primary outcome measure

Symptoms [ Time Frame: 3 weeks-6 months ]

Central Contacts and Locations

Central contacts

Lindsey Albenberg, DO

2674260139 albenbergl@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Lindsey Albenberg, DO

267-426-0139 albenbergl@chop.edu

Natalie Riebe, BA

2155190747 rieben@chop.edu

Principal Investigator:

Christina Bales, MD

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-07-10.