NCT05017688

Brief Summary

The objective of the ORION study is to explore the changes of gut microbiota composition following MaaT013 administration and its impact on the immune system in GVHD patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 6, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

2.7 years

First QC Date

July 9, 2021

Last Update Submit

October 10, 2023

Conditions

Intestinal GVHDSteroid Refractory GVHD

Keywords

gut microbiotafecal microbiotherapyintestinal GvHD

Outcome Measures

Primary Outcomes (3)

  • Change of gut microbiota diversity

    Diversity of gut microbiota will be evaluated using alpha-diversity metric (Simpson or Shannon or Richness indice) throughout the study

    inclusion (day 0) to month 6

  • Change of gut microbiota composition

    Sample comparisons will be performed using similarity metric such as Bray-Curtis, Jaccard distances, Sorensen, Pearson or Spearman indice.

    inclusion (day 0) to month 6

  • Change of gut microbiota composition (phylogenetic profiles)

    Gut microbiota composition will be evaluated with phylogenetic profiling. Relative abundance of bacterial taxa will be described at each visit throughout the study.

    inclusion (day 0) to month 6

Secondary Outcomes (3)

  • Correlation between gut microbiota and immune parameters

    inclusion (day 0) to month 6

  • Gut microbiota baseline characterization based on clinical response

    day 0

  • Change in immune parameters following MaaT013 administration

    inclusion (day 0) to month 6

Study Arms (1)

Patient population

OTHER

The population of the study will be adult patients with GI-aGVHD grade III to IV undergoing MaaT013 treatment through named-patient use program ATUn (Early Access Program). Blood and stool samples will be collected at each visit to analyse the gut microbiota and the immune cells.

Procedure: Blood and stool sample collection

Interventions

Blood and stool sample collectionPROCEDURE

Collection of blood samples (55 mL) Collection of fecal samples (10g)

Patient population

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient ≥18 years old with Grade III-IV aGVHD with gut involvement undergoing treatment with MaaT013 through named-patient use program ATUn / Early Access
  • Signature of informed and written consent by the subject or by the subject's legally acceptable representative for patients under guardianship or trusteeship.
  • Affiliated or recipient from a social security scheme

You may not qualify if:

  • Pregnancy and breastfeeding
  • Vulnerable patients such as: minors, persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Chu Amiens Picardie Site Sud

Amiens, 80054, France

RECRUITING

Chu de Caen

Caen, 14033, France

RECRUITING

Chu Grenoble

Grenoble, 38043, France

RECRUITING

Chu de Nice - L'Archet 1

Nice, 06200, France

RECRUITING

Aphp - Hopital Saint Antoine

Paris, 75012, France

RECRUITING

Chu Lyon Sud

Pierre-Bénite, 69310, France

ACTIVE NOT RECRUITING

Chu La Miletrie

Poitiers, 86021, France

RECRUITING

Chu de Rennes - Hopital Pontchaillou

Rennes, 35033, France

ACTIVE NOT RECRUITING

Institut Universitaire Du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Sarah Guenounou, MD

    IUCT ONCOPOLE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliette JOUVE

CONTACT

+33 4 28 29 14 00orion@maat-pharma.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective interventional with low risks and constraints study (RIPH2)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2021

First Posted

August 24, 2021

Study Start

October 6, 2021

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

October 11, 2023

Record last verified: 2023-10

Locations

FR(9)