Recruiting

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

Sponsor:

Indiana University

Code:

NCT05821309

Conditions

Constipation

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Accepted

Interventions

PEG 3350

PEG-3350 with electrolytes

Glycerin

Study Details

Brief summary:

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.

Conditions

Constipation

Study ID

NCT05821309

Start date

Jun 8, 2023

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Accepted

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

Study Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: PEG 3350

Patients will receive PEG 3350 (miralax or generic equivalent) for their MACE flushes.

experimental: PEG 3350 with electrolytes

Patients will receive PEG 3350 with electrolytes (Go-Lytely or generic equivalent) for their MACE flushes.

Interventions

PEG 3350

The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing. PEG 3350 will be compared to PEG 3350 with electrolytes

PEG-3350 with electrolytes

Glycerin

Glycerin will be given to patients based on standard of care, at the discretion of the pediatric gastroenterology and pediatric surgery teams. Glycerin administration will not be randomized. For secondary analysis, the microbiomes of those who have and have not received glycerin will be compared.

Primary outcome measure

Change in Fecal Microbiome at 1 month [ Time Frame: At baseline and 1 month post-MACE ]
Change in Fecal Microbiome at 4 months [ Time Frame: At baseline and 4 months post-MACE ]
Change in Fecal Microbiome at 8 months [ Time Frame: At baseline and 8 months post-MACE ]

Central Contacts and Locations

Central contacts

Erik Andrewski, MD

317-944-3774 edandrew@iupui.edu

Ann Klipsch, RN

317-944-3774 aeye@iu.edu

Locations

IU North Hospital

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Erik Andrewski, MD

317-944-3774 edandrew@iu.edu

Ann Klipsch, RN

317-944-3774 aeye@iu.edu

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46224

Contacts

Erik Andrewski, MD

317-944-3774 edandrew@iupui.edu

Ann Klipsch, RN

317-944-3774 aeye@iu.edu

Principal Investigator:

Kate Hawa, DO

More Information

Sponsor

Indiana University

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-18.