Home › Constipation › NCT05821309
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Who can join
Ages 2 to 18 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Recalcitrant chronic functional constipation necessitating a MACE appendicostomy or cecostomy for treatment at Riley Hospital for Children * Intact colonic motility as evidenced by CMS studies Exclusion Criteria * Underlying anatomic or pathologic etiology for constipation * History of prior gastrointestinal surgery (excluding placement of G or GJ tubes) * Underlying severe GI disease unrelated to the patient's chronic constipation * Use within the past month of consent of probiotic supplements, prebiotic supplements or antibiotics
About the study
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.
What is being tested
- PEG 3350 (drug)
- PEG-3350 with electrolytes (drug)
- Glycerin (drug)
Sponsor: Indiana University · Participants: 65 · Started: Jun 8, 2023
Contact the study team
- Erik Andrewski, MD · Phone: 317-944-3774
- Ann Klipsch, RN · Phone: 317-944-3774
Official record on ClinicalTrials.gov — NCT05821309
Locations in the U.S.
| Indiana | IU North Hospital, Carmel Riley Hospital for Children, Indianapolis |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.