Evaluating chyme reinfusion methods after small bowel surgery
Official title: Prospective Study of the Methods and Outcomes of CHYME REinstillation After Small Bowel Surgery
Run by Nantes University Hospital · NCT06751628 · Data updated 2026-11-12
This study is testing if a method called chyme reinfusion can help patients with serious digestive issues after bowel surgery by improving their nutrition and reducing fluid loss.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes, Nantes) |
| Status | Recruiting |
| Started | July 14, 2024 |
| Main results expected | July 14, 2029 |
| Study ends | July 14, 2030 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT06751628 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with high-output stomas or enterocutaneous fistulas producing over 1500 mL of output per day, or over 1000 mL with adverse effects on hydration and nutrition.
✕Probably not a fit
Patients with strictures or fistulas in the downstream digestive segment, or those unable to use the device due to cognitive or motor impairments, 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 observational study focuses on patients with high-output enterocutaneous fistulas and double enterostomies, which are serious complications following abdominal surgery. It aims to assess the nutritional outcomes and digestive losses before and after the implementation of chyme reinfusion (CR) therapy. By comparing data from the periods before and during CR, the study seeks to understand the effectiveness of this intervention in managing fluid and nutrient loss. The methodology includes both descriptive and analytical approaches to evaluate the impact of CR on patient health.
Why it matters
Potential benefit: If successful, this study could significantly improve the management of patients with high-output enterostomies, potentially reducing the need for parenteral nutrition and enhancing their quality of life.
How similar studies have gone: While the approach of chyme reinfusion is innovative, similar studies have not been widely reported, indicating this may be a novel intervention.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: High-output stoma or enterocutaneous fistula (\>1500 mL per day or \>1000 mL per day with impact on hydration and nutritional status) Double enterostomy or enterocutaneous fistula with an anatomical configuration allowing chyme reinfusion (CR) Confirmed patency of the downstream digestive segment through digestive contrast imaging Exclusion Criteria: Stricture or fistula in the downstream digestive segment Patient refusal to use the device Fine motor or cognitive impairments preventing the patient or a caregiver from handling the device
Where it's running
-
CHU de Nantes
Nantes, Nantes, France Recruiting
Study contacts
- Study coordinator: EMILIE DUCHALAIS, MD PhD
- Email: EMILIE.DUCHALAIS@CHU-NANTES.FR
- Phone: 0253484322
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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.