ACTIVE_NOT_RECRUITING

Fiber Food Introduction in Pediatric Short Bowel Syndrome

Talk to us

Conditions

Short Gut Syndrome

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-08
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05432648

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Months to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Actively follows at the Children's Hospital of Philadelphia (CHOP) outpatient clinics
  2. * 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
  3. * Control arm specific: No history of intestinal pathologies
  4. * No or negligible amount (few bites of fiber-containing foods okay) of fiber in tube feeds or by mouth at baseline
  5. * Less than 20% calories from oral food not containing fiber while the other 80% may be by enteral and/or parenteral feedings
  6. * At least 20% calories from fiber-free formula taken orally or via tube
  7. * 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.
  8. * Previous history of fiber introduction failure is acceptable as long as clinically stable at the time of recruitment
  9. * Fiber supplementation is appropriate per primary physician
  10. * If subject is unable to provide full set of samples, they will still be enrolled
  1. * SBS Arm specific: No diagnosis of SBS.
  2. * Control Arm specific: has baseline intestinal diseases
  3. * Small bowel and colon not in continuity (Ex: presence of ileostomy or jejunostomy)
  4. * \>5% changes in percentage of calories from oral nutrition (PO), enteral nutrition (EN) and/or parenteral nutrition (PN) during the intervention
  5. * Addition/discontinuation/significant alteration to antibiotics regimen during study period
  6. * Primary physician does not think fiber supplementation is appropriate clinically

Contacts and Locations

Principal Investigator

Lindsey Albenberg, DO
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Christina Bales, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Wenjing Zong, MD
STUDY_DIRECTOR
Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

  • Lindsey Albenberg, DO, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia
  • Christina Bales, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia
  • Wenjing Zong, MD, STUDY_DIRECTOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-08
Study Completion Date2026-05

Study Record Updates

Study Start Date2022-05-08
Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

  • Short Gut Syndrome