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

RecruitingPhase 4Ages 2 Years - 18 YearsAllIndiana University
NCT05821309 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • PEG 3350
  • PEG-3350 with electrolytes
  • Glycerin
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Where

2 sites
IU North Hospital
Carmel, United States
Riley Hospital for Children
Indianapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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