Clinical Tolerance and Microbiome Changes Following Fiber Food Introduction in Short Bowel Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Dietary Supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4 months
Maximum Age: 18
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Actively follows at CHOP outpatient clinics

• SBS arm specific: History of SBS diagnosis. History of short bowel syndrome based on surgical/imaging records. Has ileocecal resection (No ICV) and 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

Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
Recruiting
Philadelphia
Contact Information
Primary
Wenjing Zong, MD
zongw@chop.edu
2674557884
Time Frame
Start Date: May 8, 2022
Estimated Completion Date: May 2026
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Philadelphia
Collaborators: University of Pennsylvania

This content was sourced from clinicaltrials.gov

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