Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05889572
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-04-17
Brief Title:
Safety and Gut Microbiota Analysis of an Oral Microbiotherapy in Patients With Amyotrophic Lateral Sclerosis
Sponsor:
MaaT Pharma
Organization:
MaaT Pharma
Study Overview
Official Title:
Safety Tolerability and Gut microbIota AnalysiS of an Oral Microbiotherapy in Amyotrophic Lateral Sclerosis an Open-label Phase 1b Pilot Trial
Status:
ACTIVE_NOT_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:
IASO
Brief Summary:
The purpose of this pilot study is to assess the safety and tolerability of multiple doses of MaaT033 in ALS patients and to analyze the gut microbiota composition and evolution before considering a larger randomized controlled efficacy study
Detailed Description:
This is a prospective single arm open-label study
The target population includes subjects with a recent disease onset defined as the time from first motor deficit at screening of at least 6 months and up to 24 months and removing very rapidslow progressors based on the ALS Functional Rating Scale - Revised ALSFRS-R progression slope
After a screening period clinical examination blood sampling subject will come for a baseline visit clinical examination blood and feces sampling and to initiate a bowel preparation phase Five days later subject will come back to the study site clinical examination blood sampling to initiate a first Maat033 treatment period of 28-day Ten days after MaaT033 treatment initiation a remote visit is included feces sampling to check the subject safetytolerability After the first Maat033 treatment period subject will come to the study site clinical examination blood and feces sampling to initiate the second MaaT033 treatment period of 28-day At the end of the second Maat033 treatment period subjects will come to the study site clinical examination blood and feces sampling and start a 28-day follow-up period without treatment
Study completion is defined when all subjects enrolled completed the study follow-up period clinical examination blood and feces sampling or earlier if a subject discontinued the study
The target population includes subjects with a recent disease onset defined as the time from first motor deficit at screening of at least 6 months and up to 24 months and removing very rapidslow progressors based on the ALS Functional Rating Scale - Revised ALSFRS-R progression slope
After a screening period clinical examination blood sampling subject will come for a baseline visit clinical examination blood and feces sampling and to initiate a bowel preparation phase Five days later subject will come back to the study site clinical examination blood sampling to initiate a first Maat033 treatment period of 28-day Ten days after MaaT033 treatment initiation a remote visit is included feces sampling to check the subject safetytolerability After the first Maat033 treatment period subject will come to the study site clinical examination blood and feces sampling to initiate the second MaaT033 treatment period of 28-day At the end of the second Maat033 treatment period subjects will come to the study site clinical examination blood and feces sampling and start a 28-day follow-up period without treatment
Study completion is defined when all subjects enrolled completed the study follow-up period clinical examination blood and feces sampling or earlier if a subject discontinued the study
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