NCT05821309 Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
| NCT ID | NCT05821309 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Indiana University |
| Condition | Constipation |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2023-06-08 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 65 participants in total. It began in 2023-06-08 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Kate Hawa, DO
PRINCIPAL INVESTIGATOR
Riley Hospital for Children
Frequently Asked Questions
Who can join the NCT05821309 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying Constipation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05821309 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05821309 currently recruiting?
Yes, NCT05821309 is actively recruiting participants. Contact the research team at edandrew@iupui.edu for enrollment information.
Where is the NCT05821309 trial being conducted?
This trial is being conducted at Carmel, United States, Indianapolis, United States.
Who is sponsoring the NCT05821309 clinical trial?
NCT05821309 is sponsored by Indiana University. The principal investigator is Kate Hawa, DO at Riley Hospital for Children. The trial plans to enroll 65 participants.