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

ConditionConstipation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-18
SponsorIndiana University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • PEG 3350
  • PEG-3350 with electrolytes
  • Glycerin

Treatment groups

65 Participants
are divided into 2 treatment groups

Sponsors and collaborators