Safety and Gut Microbiota Analysis of an Oral Microbiotherapy in Patients With Amyotrophic Lateral Sclerosis (IASO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05889572|
Recruitment Status : Recruiting
First Posted : June 5, 2023
Last Update Posted : October 11, 2023
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis ALS||Drug: MaaT033||Phase 1|
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 rapid/slow 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 safety/tolerability. 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety, Tolerability and Gut microbIota AnalysiS of an Oral Microbiotherapy in Amyotrophic Lateral Sclerosis; an Open-label Phase 1b Pilot Trial|
|Actual Study Start Date :||June 8, 2023|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||June 2024|
Route of administration: oral (capsule)
Between D-5 to D-1: Bowel preparation with Macrogol and Rifamixin
Between D1 to D28: MaaT033 treatment period 1
Between D28 to D56: MaaT033 treatment period 2
MaaT033 is a Microbiome Ecosystem Therapy (MET), composed of allogeneic, full-ecosystem pooled biotherapeutic gut microbiota.
- Safety and tolerability: Incidence of Treatment Emergent Adverse Events (TEAE) grade >3, according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: Day 84 ]To assess the safety and tolerability of MaaT033 treatment
- Changes in gut microbiota profile [ Time Frame: From Day -5 to Day 84 (at Day -5, Day 10, Day 28, Day 56 and Day 84) ]Analysis of fecal samples to assess gut microbiota alpha- and beta-diversity indices
- Changes in levels of biomarkers in blood [ Time Frame: From Day -5 to Day 84 ]
- Changes from baseline (Day -5) of neutrophil/ lymphocyte ratio, Interleukins (IL): IL-2, IL-6 and IL-8, Interferon gamma (IFNg), Tumor Necrosis Factor alpha (TNFa), Monocyte Chemoattractant Protein-1 (MCP-1), Transforming Growth Factor-beta (TGFb), the soluble subtype of CD14 (sCD14), C-reactive protein (CRP), erythrocyte sedimentation rate, plasma soluble Lipopolysaccharide Binding Protein (LBP), creatinin and serum Short-Chain Fatty Acids (SCFA) at Day 28, Day 56 and Day 84.
- Changes from baseline (Day -5) of serum Neurofilament light (NfL) at Day 56 and Day 84.
- Changes in levels of fecal calprotectin [ Time Frame: From Day -5 to Day 84 ]Changes from baseline (Day -5) of fecal calprotectin at Day 10, Day 28, Day 56 and Day 84
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05889572
|Contact: Juliette Jouve||+33 4 28 29 14 firstname.lastname@example.org|
|Centre Hospitalier Universitaire de Lille - CIC||Recruiting|
|Lille, France, 59037|
|Contact: Véronique DANEL, MD|
|Hôpital de la Pitié-Salpêtrière - CIC Neuroscience||Recruiting|
|Paris, France, 75013|
|Contact: Gaelle Bruneteau, MD, PhD|
|Principal Investigator:||Gaelle Bruneteau, MD, PhD||Hôpital de la Pitié-Salpêtrière - CIC Neuroscience|