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

Launched by INDIANA UNIVERSITY · Apr 7, 2023

Keywords

ClinConnect Summary

This clinical trial is designed to study how a specific treatment for constipation in children affects the bacteria in their intestines. The treatment involves placing an antegrade continence enema (a method that helps manage bowel movements) and starting a bowel flush regimen. Researchers will collect stool samples from participants both before and after the treatment to see how the bacteria change over time. They will compare samples taken right before the treatment to those taken at 0, 4, and 8 months after starting the enema and flushes.

To be eligible for this study, children must have chronic constipation that hasn't improved with other treatments and require a special procedure called a MACE appendicostomy or cecostomy. They should also have normal bowel function as shown by certain tests. However, children with certain gastrointestinal diseases or those who have had major surgeries or taken specific supplements recently won't be able to participate. If your child qualifies, they can expect to provide stool samples at various points during the study, and this research could help improve treatments for constipation in the future.

Gender

ALL

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