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

PHASE4RecruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

June 8, 2023

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Constipation
Interventions
DRUG

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

DRUG

PEG-3350 with electrolytes

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

DRUG

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.

Trial Locations (2)

46032

RECRUITING

IU North Hospital, Carmel

46224

RECRUITING

Riley Hospital for Children, Indianapolis

All Listed Sponsors
lead

Indiana University

OTHER