Evaluating changes in gut bacteria after enema treatment for constipation in children
Official title: Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Run by Indiana University · NCT05821309 · Data updated 2026-11-12
This study is testing how a special enema treatment for constipation affects the gut bacteria in children aged 2 to 18 over several months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Enrollment | 65 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 2 sites (Carmel, Indiana and 1 other locations) |
| Status | Recruiting |
| Started | June 8, 2023 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT05821309 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 2 to 18 years with chronic functional constipation requiring a MACE procedure and intact colonic motility.
✕Probably not a fit
Patients with underlying anatomical or pathological causes of constipation or those who have had prior gastrointestinal surgeries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the changes in the fecal microbiome of pediatric patients suffering from chronic functional constipation before and after the placement of a Malone Antegrade Continence Enema (MACE) and the initiation of a bowel flush regimen. Children aged 2 to 18 years will have their microbiome sequenced through stool samples collected at various intervals: before the procedure and at 1, 4, and 8 months post-treatment. The study will also randomize the bowel flush regimen between two types of PEG solutions to assess their impact on microbiome diversity. The research aims to provide insights into how these interventions affect gut health in constipated children.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for chronic constipation in pediatric patients by understanding the role of the microbiome.
How similar studies have gone: While studies on the microbiome and constipation exist, this specific approach combining MACE and microbiome analysis is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
IU North Hospital
Carmel, Indiana, United States Recruiting -
Riley Hospital for Children
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: Kate Hawa, DO — Riley Hospital for Children
- Study coordinator: Erik Andrewski, MD
- Email: edandrew@iupui.edu
- Phone: 317-944-3774
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.