Trials / Completed
CompletedNCT02990195
Restoring the Beneficial Effects of Enterohepatic Bile Salt Signalling by Chyme Reinfusion in Patients With a Double Enterostomy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Rennes University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Multicentre prospective human experimental study to determine the effect of chyme reinfusion in patients with a double enterostomy on plasma levels of Fibroblast Growth Factor (FGF19)
Detailed description
Patients supported by chyme reinfusion will be followed for 3 days pre chyme reinfusion and for 7 weeks during chyme reinfusion. Three days prior chyme reinfusion, baseline characteristics will be determined, an ileal biopsy, blood, chyme and urine will be collected. Furthermore, blood, chyme, faeces and urine will be collected at the first day of chime reinfusion. These materials will be collected again at week 1, 3, 5 and 7 weeks after initiation of chyme reinfusion. A second ileal biopsy will be performed at week 3.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Chyme reinfusion |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2018-07-02
- Completion
- 2018-07-02
- First posted
- 2016-12-13
- Last updated
- 2023-05-24
Locations
3 sites across 2 countries: France, Netherlands
Source: ClinicalTrials.gov record NCT02990195. Inclusion in this directory is not an endorsement.