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

Part of paid clinical trials in Carmel, Indiana.

Sponsor
Indiana University
Study ID
NCT05821309
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Constipation

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Accepted

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
  • 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
  • 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.

Study Details

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.

Key Dates

Start date
Jun 8, 2023
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
65 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
IU North HospitalCarmelIndiana46032
Erik Andrewski, MD
[email protected]
317-944-3774
Ann Klipsch, RN
[email protected]
317-944-3774
Riley Hospital for ChildrenIndianapolisIndiana46224
Erik Andrewski, MD
[email protected]
317-944-3774
Ann Klipsch, RN
[email protected]
317-944-3774
Kate Hawa, DO (PRINCIPAL_INVESTIGATOR)

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By research site
IU North Hospital· Carmel, INRiley Hospital for Children· Indianapolis, IN

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