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Intestinal GVHDORIONNCT05017688

Prospective Interventional Study Exploring the Microbiota Recolonization in SR-GvHD Patients Receiving MaaT013

A study testing Blood and stool sample collection in people with Intestinal GVHD and Steroid Refractory GVHD, run by MaaT Pharma at 9 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Intestinal GVHD, Steroid Refractory GVHD
What is being tested?
Blood and stool sample collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
9 sitesFrance
Study dates
6 Oct 2021to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 1 country.

Juliette JOUVE contact

+33 4 28 29 14 00

orion@maat-pharma.com

9 sites in 1 country

France9 sites, 7 recruiting

  • Chu Amiens Picardie Site Sud

    Amiens, 80054

    AMANDINE CHARBONNIER, MD, 03 22 45 59 14, charbonnier.amandine@chu-amiens.fr

    AMANDINE CHARBONNIER, MD

    Recruiting

  • Chu de Caen

    Caen, 14033

    CHANTEPIE SYLVAIN, MD, 02 31 27 20 73, chantepie-s@chu-caen.fr

    CHANTEPIE SYLVAIN, MD

    Recruiting

  • Chu Grenoble

    Grenoble, 38043

    CARRE MARTIN, MD, 04 76 76 57 55, MCarre1@chu-grenoble.fr

    CARRE MARTIN, MD

    Recruiting

  • Chu de Nice - L'Archet 1

    Nice, 06200

    LOSCHI MICHAEL, MD, 04 92 03 58 41, loschi.m@chu-nice.fr

    LOSCHI MICHAEL, MD

    Recruiting

  • Aphp - Hopital Saint Antoine

    Paris, 75012

    FLORENT MALARD, MD, 01 49 28 34 39, florent.malard@aphp.fr

    FLORENT MALARD

    Recruiting

  • Chu Lyon Sud

    Pierre-Bénite, 69310

    Active, not recruiting

  • Chu La Miletrie

    Poitiers, 86021

    DESMIER DEBORAH, MD, 05 49 44 44 44, deborah.desmier@chu-poitiers.fr

    Recruiting

  • Chu de Rennes - Hopital Pontchaillou

    Rennes, 35033

    Active, not recruiting

  • Institut Universitaire Du Cancer de Toulouse - Oncopole

    Toulouse, 31059

    SARAH GUENOUNOU, MD, 05 31 15 63 92, guenounou.sarah@iuct-oncopole.fr

    SARAH GUENOUNOU, MD

    Recruiting

Other trials in France

About this study

Official title: PrOspective inteRventional Study Exploring the mIcrobiota recolONization in Steroid-Refractory Graft-versus-Host Disease Patients Receiving MaaT013

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.

Read the detailed description

The french regulatory authority ANSM approved in July 2019 the use of MaaT013, a pooled microbiome-based enema formulation, under a formalized named-patient use program in France called "Autorisation Temporaire d'Utilisation - ATU nominative protocolisée - ATUn" or Early Access.

The ATUn is indicated to provide a benefit in the treatment of patients with grade III-IV aGVHD:

  • In case of initial resistance to CS alone or in association or in case of failure to other treaments
  • In first-line therapy in association with CS in case of steroid-dependance (inability to taper CS dose <0.5 mg/kg/d)
  • In case of digestive aGvHD with overlap syndrome 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.

Blood and stool samples will be collected at each visit which explained why the study is thus categorized as research involving the human person with low risks and constraints clinical trial (RIPH2).

Being tested
Blood and stool sample collection
Keywords
gut microbiota, fecal microbiotherapy, intestinal GvHD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood and stool sample collectionProcedure or surgery

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

Study groups in NCT05017688
Study groupRoleWhat they receive
Patient populationOtherThe 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.
Receives: Procedure: Blood and stool sample collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: inclusion (day 0) to month 6

  2. Change of gut microbiota composition

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

    Measured: inclusion (day 0) to month 6

  3. 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.

    Measured: inclusion (day 0) to month 6

Secondary outcomes (3)

  1. Correlation between gut microbiota and immune parameters

    Multiparameter analyses will be performed to identify correlations between changes in gut microbiota composition and immune parameters (Citrulline, Zonulin, ST2, 3 indoxyl sulfate, Reg3a, Total antioxidant status, TGFb1.2.3., IL-1b, IL-2, sIL-2ra, IL-6, IL-8, IL10, IL17-A, IL-18, IFNg, TNFa, sCD14, MCP1, CCL25, CCL28, sCD30, CXCL10)

    Measured: inclusion (day 0) to month 6

  2. Gut microbiota baseline characterization based on clinical response

    Stratification of patients will be based on response to MaaT013 treatment at day 28. Then gut microbiota composition will be described in responder versus non responder patients.

    Measured: day 0

  3. Change in immune parameters following MaaT013 administration

    Cytokines and immune parameters of interest (Citrulline, Zonulin, ST2, 3 indoxyl sulfate, Reg3a, Total antioxidant status,TGFb1.2.3., IL-1b, IL-2, sIL-2ra, IL-6, IL-8, IL10, IL17-A, IL-18, IFNg, TNFa, sCD14, MCP1, CCL25, CCL28, sCD30, CXCL10) will be measured in plasma/serum by Luminex and ELISA at each visit and compared to baseline.

    Results will be expressed as ratios on D0 value and heatmap.

    Peripheral blood mononuclear cells will be purified then analyzed by flow cytometry using specific antibodies (CD4, CD8α, CD8β,TCRαβ, CD49a, CCR6, CXCR6, CD25, CD127, CCR7, CD69, CD45RA, CD27, CD57, GITR, CD39, C. Transcriptomic analysis by single cell CITE-seq will be performed on some lymphocytes subgroups.

    Measured: inclusion (day 0) to month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2021
  2. Study start6 Oct 2021
  3. Primary completionJun 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective interventional with low risks and constraints study (RIPH2)
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05017688
Sponsor's protocol ID
MPOH07
Acronym
ORION
Status last verified
Oct 2023
First submitted
9 Jul 2021
Last updated
11 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Blood and stool sample collection in people with Intestinal GVHD and Steroid Refractory GVHD, run by MaaT Pharma at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Juliette JOUVE (+33 4 28 29 14 00, orion@maat-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of gut microbiota diversity (time frame: inclusion (day 0) to month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05017688.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.

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