Fiber Food Introduction in Pediatric Short Bowel Syndrome

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05432648
Status
Recruiting
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Conditions

  • Short Gut Syndrome

Eligibility Criteria

Sex
ALL
Age
4 Months - 18 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Jun 27, 2022
Start date
May 8, 2022
Status verified
Jul 2026
Primary completion
Aug 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Symptoms [ Time Frame: 3 weeks-6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Lindsey Albenberg, DO
[email protected]
267-426-0139
Natalie Riebe, BA
[email protected]
2155190747
Christina Bales, MD (PRINCIPAL_INVESTIGATOR)
Lindsey Albenberg, DO (PRINCIPAL_INVESTIGATOR)
Wenjing Zong, MD (SUB_INVESTIGATOR)

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Children's Hospital of Philadelphia· Philadelphia, PA

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