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

Indiana University · NCT05821309

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2–18 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
65
US sites recruiting
2
Study start
June 8, 2023
Record last updated
August 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: PEG 3350; PEG-3350 with electrolytes; Glycerin

Conditions: Constipation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • IU North Hospital

    Carmel, IN 46032

    Site contact: Erik Andrewski, MD · 317-944-3774 · edandrew@iu.edu

  • Riley Hospital for Children

    Indianapolis, IN 46224

    Site contact: Erik Andrewski, MD · 317-944-3774 · edandrew@iupui.edu

Study contacts (from the official record)

  • Erik Andrewski, MD · 317-944-3774 · edandrew@iupui.edu
  • Ann Klipsch, RN · 317-944-3774 · aeye@iu.edu
All healthy volunteers studies in Indiana →
Evaluation of Fecal Microbiome Changes After Antegrade Continence… (NCT05821309) | Bored Studies