Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306014
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-02-21
Brief Title:
Evaluation of EXL01 a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Evaluation of EXL01 a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
Status:
RECRUITING
Status Verified Date:
2024-06
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:
LIVEDIFF
Brief Summary:
Clostridioides difficile infection CDI is the leading cause of nosocomial diarrhea in Europe with over 120000 cases and almost 3700 deaths per year This infection is characterized by a high risk of recurrence after cure ranging from almost 20 after a first episode to over 60 after 2 recurrences or in the case of specific risk factors
Currently first-line treatment of CDI is based on oral antibiotics such as fidaxomicin or vancomycin These antibiotic treatments which are effective in 89 and 86 of first-episode cases respectively do not correct the microbiological imbalance underlying the onset of CDI and may on the contrary encourage recurrence by contributing to the maintenance of a deleterious change in the microbiota dysbiosis through the elimination of bacteria other than C difficile due to their spectrum of activity In a number of patients this ecological imbalance can no longer be restored after antibiotic treatment leading to multiple recurrences of CDI
In this context fecal microbiota transplantation FMT has been validated for over 10 years for the prevention of recurrence in multi-recurrent CDI The principle of FMT is based on the use of a pharmaceutical preparation made from the stool of a healthy donor administered within the digestive tract of a patient for therapeutic purposes
Currently in the case of multiple recurrences it is the recommended first-line treatment from 2 recurrences and the most effective with a clinical efficacy preventing recurrence of CDI in 69 to 89 of cases at 8 weeks post-treatment with a good safety profile
Among the microbial factors promoting CDI the loss of the bacterial species Faecalibacterium prausnitzii constitutes a specific therapeutic target F prausnitzii is a commensal bacterium of the human gut making up nearly 5 of the fecal microbiota and has been shown to be associated with an individuals state of health A drop in its relative abundance is associated with an increased risk of numerous diseases such as Crohns disease and colorectal cancer In CDI F prausnitzii is greatly diminished Moreover low abundance of F prausnitzii is predictive of C difficile recurrence Its abundance in stools is increased after FMT and is also predictive of response to treatment From a pathophysiological point of view one of the preventive effects of F prausnitzii on recurrence would be mediated by its ability to hydrolyze the bile acids involved in the germination of C difficile spores
The aim of this Phase III trial is to assess the efficacy and safety of oral administration of EXL01 a single isolated unmodified strain of F prausnitzii in preventing CDI recurrence in high-risk patients at W8 The study will be conducted in 2 parts The phase I Part A is planned to include 6 patients The phase II Part B will include 50 patients in two arms 25 patients respectively in the placebo and EXL01 arm
Currently first-line treatment of CDI is based on oral antibiotics such as fidaxomicin or vancomycin These antibiotic treatments which are effective in 89 and 86 of first-episode cases respectively do not correct the microbiological imbalance underlying the onset of CDI and may on the contrary encourage recurrence by contributing to the maintenance of a deleterious change in the microbiota dysbiosis through the elimination of bacteria other than C difficile due to their spectrum of activity In a number of patients this ecological imbalance can no longer be restored after antibiotic treatment leading to multiple recurrences of CDI
In this context fecal microbiota transplantation FMT has been validated for over 10 years for the prevention of recurrence in multi-recurrent CDI The principle of FMT is based on the use of a pharmaceutical preparation made from the stool of a healthy donor administered within the digestive tract of a patient for therapeutic purposes
Currently in the case of multiple recurrences it is the recommended first-line treatment from 2 recurrences and the most effective with a clinical efficacy preventing recurrence of CDI in 69 to 89 of cases at 8 weeks post-treatment with a good safety profile
Among the microbial factors promoting CDI the loss of the bacterial species Faecalibacterium prausnitzii constitutes a specific therapeutic target F prausnitzii is a commensal bacterium of the human gut making up nearly 5 of the fecal microbiota and has been shown to be associated with an individuals state of health A drop in its relative abundance is associated with an increased risk of numerous diseases such as Crohns disease and colorectal cancer In CDI F prausnitzii is greatly diminished Moreover low abundance of F prausnitzii is predictive of C difficile recurrence Its abundance in stools is increased after FMT and is also predictive of response to treatment From a pathophysiological point of view one of the preventive effects of F prausnitzii on recurrence would be mediated by its ability to hydrolyze the bile acids involved in the germination of C difficile spores
The aim of this Phase III trial is to assess the efficacy and safety of oral administration of EXL01 a single isolated unmodified strain of F prausnitzii in preventing CDI recurrence in high-risk patients at W8 The study will be conducted in 2 parts The phase I Part A is planned to include 6 patients The phase II Part B will include 50 patients in two arms 25 patients respectively in the placebo and EXL01 arm
Detailed Description:
None
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 |
|---|---|---|---|
| 2023-506232-32-00 | OTHER | EU CT Number | None |