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

NCT05821309 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 17083
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change in Fecal Microbiome at 1 month

  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

  At baseline and 1 month post-MACE

• Change in Fecal Microbiome at 4 months

  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

  At baseline and 4 months post-MACE

• Change in Fecal Microbiome at 8 months

  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

  At baseline and 8 months post-MACE

Secondary Outcomes (3)

• Effect of Bowel Regimen Solution on Fecal Bacterial Diversity

  Through study completion, approximately 8 months

• Effect of Glycerin on Fecal Microbiome Diversity

  Through study completion, approximately 8 months

• Effect of Redundant Sigmoid Colon on Microbiome Diversity

  Through study completion, approximately 8 months

Study Arms (2)

PEG 3350

EXPERIMENTAL

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

Drug: PEG 3350; Drug: Glycerin

PEG 3350 with electrolytes

EXPERIMENTAL

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

Drug: PEG-3350 with electrolytes; Drug: Glycerin

Interventions

PEG 3350 DRUG

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

Also known as: MiraLAX or generic equivalent

PEG 3350

PEG-3350 with electrolytes DRUG

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

Also known as: GoLytely or generic equivalent

PEG 3350 with electrolytes

Glycerin DRUG

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.

PEG 3350; PEG 3350 with electrolytes

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

IU North Hospital

Carmel, Indiana, 46032, United States

RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, 46224, United States

RECRUITING

MeSH Terms

Conditions

Constipation

Interventions

polyethylene glycol 3350; Electrolytes; Golytely; Glycerol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Kate Hawa, DO

  Riley Hospital for Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik Andrewski, MD

CONTACT

317-944-3774; edandrew@iupui.edu

Ann Klipsch, RN

CONTACT

317-944-3774; aeye@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Only objective data in the form of fecal microbiome diversity will be obtained via 16s rRNA sequencing. Neither the participant nor the investigators will be blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: June 8, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)