A New Method for Ileostomy Output Collection Using an Intestinal Tampon

Launched by AMPA MEDICAL · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to collect output from an ileostomy using a specialized absorbent intestinal tampon. Researchers want to find out if people can comfortably and successfully insert this tampon themselves and how much discomfort they might feel during the process. The study will involve comparing different designs of the tampon to see which one works best. Participants will be guided by a medical consultant during their first attempt to insert the tampon and will later try it on their own. They will also share their experiences, including any pain or discomfort, by rating it on a simple scale. Additionally, stool samples will be collected to study the microbiome, which refers to the bacteria in the gut.

To join this study, participants must be at least 18 years old, have had an ileostomy for more than six months, and have a stoma opening that is at least 10 mm wide. People with certain health issues, like recent inflammation in the bowel or a hernia around the stoma, won't be eligible. This research aims to see if the intestinal tampon can be a good alternative to traditional stoma bags, potentially making life easier and more comfortable for those living with an ileostomy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Ileostomy \> 6 months old
• • Stoma opening ≥ 10 mm in diameter
• • Written informed consent
• Exclusion Criteria:
• • Difficulty understanding study information, including language barriers
• • Somatic illness, including active inflammatory bowel disease
• • Hernia around the stoma
• • Daily output \> 2 liters
• • Active inflammation in the ileum (diagnosed within 2 months before the study day)