RECRUITING

Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen

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

This study will evaluate changes in the fecal microbiome in constipated pediatric patients before and after antegrade continence enema placement and initiation of antegrade enema flushes. Subjects will have their microbiome sequenced prior to placement by obtaining a fecal sample. Pre-antegrade continence enema placement results will be compared to fecal samples obtained at 0, 4, 8 months after placement of the antegrade continence enema and initiation of miralax or golytely flushes to look for changes in bacterial diversity.

Official Title

Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen

Quick Facts

Study Start:2023-06-08
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05821309

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:2 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Recalcitrant chronic functional constipation necessitating a MACE appendicostomy or cecostomy for treatment at Riley Hospital for Children
  2. * Intact colonic motility as evidenced by CMS studies
  3. * Underlying anatomic or pathologic etiology for constipation
  4. * History of prior gastrointestinal surgery (excluding placement of G or GJ tubes)
  5. * Underlying severe GI disease unrelated to the patient's chronic constipation
  6. * Use within the past month of consent of probiotic supplements, prebiotic supplements or antibiotics
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Erik Andrewski, MD
CONTACT
317-944-3774
edandrew@iupui.edu
Ann Klipsch, RN
CONTACT
317-944-3774
aeye@iu.edu

Principal Investigator

Kate Hawa, DO
PRINCIPAL_INVESTIGATOR
Riley Hospital for Children

Study Locations (Sites)

IU North Hospital
Carmel, Indiana, 46032
United States
Riley Hospital for Children
Indianapolis, Indiana, 46224
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Kate Hawa, DO, PRINCIPAL_INVESTIGATOR, Riley Hospital for Children

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 Date2023-06-08
Study Completion Date2025-07

Study Record Updates

Study Start Date2023-06-08
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • Fecal microbiome
  • Malone Antegrade Continence Enema (MACE)
  • Miralax
  • PEG 3350
  • Antegrade Continence Enema
  • Chronic Constipation

Additional Relevant MeSH Terms

  • Constipation