Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433180
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-13
Brief Title:
Study of Fecal Microbiota Transplantation FMT in Severe IBS Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
A Prospective Multi-center Double Blind Randomized Trial of Fecal Microbiota Transplantation FMT Delivered by Capsule Versus Placebo in Severe Irritable Bowel Syndrome IBS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICEBOAT
Brief Summary:
The objective of this protocol is to evaluate the efficacy of fecal microbiota transplantation FMT using oral capsules containing frozen stools vs sham FMT on IBS severity score at 12 weeks in patients with severe irritable bowel syndrome refractory to conventional treatments
Detailed Description:
Irritable bowel syndrome IBS is a chronic disease It affects about 44 to 10 of the French general population according to Rome III or Rome IV definition and is the most frequent functional bowel disorder in patients visiting general practitioners or gastroenterologists The efficacy of treatments is often limited in particular form the case severe of IBS IBS-SSS300 which concerns at least 20 to 25 of patients and IBS can cause significant deterioration in quality of life
In this context microbiota could become a potential therapeutic target and replacement of the abnormal fecal microbiota by an healthy one especially in patients refractory to previous treatment and with severe symptoms is a seducing new therapeutic strategy The primary outcome is an improvement in the IBS-SSS score level at 12 weeks after taking a oral capsules of FMT in patients with severe IBS
In this context microbiota could become a potential therapeutic target and replacement of the abnormal fecal microbiota by an healthy one especially in patients refractory to previous treatment and with severe symptoms is a seducing new therapeutic strategy The primary outcome is an improvement in the IBS-SSS score level at 12 weeks after taking a oral capsules of FMT in patients with severe IBS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-003433-41 | EUDRACT_NUMBER | None | None |