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RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Indiana University • ClinicalTrials.gov ID: NCT05821309

Registry updated: 2026-08-18
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Description

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.

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.

Eligibility 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

Conditions

Constipation

Locations

  • IU North Hospital — Carmel, Indiana, United States
  • Riley Hospital for Children — Indianapolis, Indiana, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record