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Fecal Microbiota TransplantationPhase 2HERACLESNCT03359980

Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer

A Phase 2 study testing fecal microbiota transfer in people with Fecal Microbiota Transplantation, run by MaaT Pharma at 16 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fecal Microbiota Transplantation
What is being tested?
fecal microbiota transfer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
16 sitesin 3 countries
Study dates
13 Aug 2018to 26 Nov 2020
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who develop a first episode of Stage 2 to 4 Gastro-intestinal Acute Graft-versus-Host (GI-aGVHD) with gut predominance (Przepiorka D, 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose) (SR GI-aGVHD)
  • Age ≥ 18 years old
  • Allogeneic Hematopoietic stem cell transplantation (Allo-HSCT) with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
  • Patients able to have a minimum of 12 hours discontinuation of systemic antibiotics in order to perform the allogeneic FMT
  • Signature of informed and written consent by the subject or by the subject's legally acceptable representative

Who cannot join

  • Grade IV hyper-acute GVHD
  • Overlap chronic GVHD
  • Acute GVHD after donor lymphocytes infusion
  • Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
  • Active uncontrolled infection according to the attending physician
  • Other systemic drugs than corticosteroids for GVHD treatment (including extra-corporeal photopheresis). Drugs already being used for GVHD prevention (eg. calcineurin inhibitors) are allowed.
Show all 13Show fewer
  • Absolute neutrophil count < 0.5 x 10^9 /L
  • Absolute platelet count < 10 000
  • Patient Epstein-Barr Virus (EBV) negative
  • Evidence of toxic megacolon or gastrointestinal perforation on abdominal X-ray
  • Known allergy or intolerance to trehalose or maltodextrin
  • Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female of childbearing potential
  • Other ongoing interventional protocol that might interfere with the current study primary endpoint.

Trial locations and contacts

16 sites in 3 countries.

16 sites in 3 countries

France12 sites

  • CHU Amiens

    Amiens, 80054

  • CHU Angers

    Angers, 49933

  • CHRU Besançon

    Besançon, 25030

  • Hôpital Henri Mondor

    Créteil, 94000

  • CHRU Lille

    Lille, 59037

  • CHU Limoges

    Limoges, 87000

  • CHU Nantes

    Nantes, 44000

  • Hôpital Saint Antoine

    Paris, 75012

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • CHU Strasbourg

    Strasbourg, 67098

  • IUCT Oncopole

    Toulouse, 31100

Other trials in France

Poland3 sites

  • Klinika Hematologii i Transplantologii

    Gdansk, 80-952

  • Public Clinic Hospital

    Katowice, 40-032

  • University Clinical hospital

    Wroclaw, 50-556

Other trials in Poland

Italy1 site

  • Gemelli Hospital

    Roma, 168

Other trials in Italy

About this study

Official title: Treatment of Steroid Refractory Gastro-intestinal Acute Graft-versus-Host disEase afteR AllogeneiC Hematopoietic Stem celL Transplantation With fEcal Microbiota tranSfer

Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality. There is an interest in identifying effective second line therapy for these patients corticosteroid-resistant acute GVHD. Fecal microbiota transfer might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.

Being tested
fecal microbiota transfer

What participants receive

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

  • fecal microbiota transferDrug

    Also called MaaT013

    transfer of fecal microbiota from healthy donors to the patients

Study groups in NCT03359980
Study groupRoleWhat they receive
treated patientsExperimentalTreated with Fecal Microbiota Transfer (FMT)
Receives: Drug: fecal microbiota transfer

What is being measured

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

  1. Efficacy of FMT in the treatment of Steroid Refractory -Gastro-intestinal Acute GVHD (SR-GI-aGVHD) at D28 post inclusion

    Proportion of patients achieving GI and overall GVHD response by D28, defined as Complete response (CR) or Very Good Partial Response (VGPR)

    Measured: up to 4 weeks post inclusion

Secondary outcomes (5)

  1. Safety of FMT in patients with SR-GI-aGVHD

    The overall safety of the study will be evaluated with the incidence of all Adverse Events (AEs) and Serious Adverse Events (SAEs) (frequency, grade, relationship) throughout the study period

    Measured: through study completion, an average of six months

  2. Gastrointestinal GVHD overall response rate at D28 post inclusion

    Proportion of patients achieving GI and overall GVHD response by D28, defined as Complete response (CR) or Very Good Partial Response (VGPR) or Partial Response (PR)

    Measured: Day 28

  3. Number of patients with infectious disorders

    Evaluation of FMT activity on infectious disorders

    Measured: through study completion, an average of six months

  4. Number of multidrug resistant bacteria in faeces

    Evaluation of FMT activity on multidrug-resistant bacteria (MDRB) carriage

    Measured: through study completion, an average of six months

  5. Number of patients with Chronic GVHD

    Chronic GVHD expression

    Measured: through study completion, an average of six months

Timeline

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

  1. First posted2 Dec 2017
  2. Study start13 Aug 2018
  3. Primary completion25 Feb 2020
  4. Study completion26 Nov 2020

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03359980
Sponsor's protocol ID
MPOH03
Acronym
HERACLES
Status last verified
Feb 2021
First submitted
20 Nov 2017
Last updated
23 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Malard F, Loschi M, Huynh A, Cluzeau T, Guenounou S, Legrand F, Magro L, Orvain C, Charbonnier A, Panz-Klapuch M, Desmier D, Mear JB, Cornillon J, Robin C, Daguindau E, Bilger K, Vehreschild MJGT, Chevallier P, Labussiere-Wallet H, Mediavilla C, Couturier MA, Bulabois CE, Camus V, Chantepie S, Ceballos P, Gaugler B, Holler E, Dore J, Prestat E, Gasc C, Plantamura E, Mohty M. Pooled allogeneic faecal microbiota MaaT013 for steroid-resistant gastrointestinal acute graft-versus-host disease: a single-arm, multicentre phase 2 trial. EClinicalMedicine. 2023 Jul 26;62:102111. doi: 10.1016/j.eclinm.2023.102111. eCollection 2023 Aug.

    PubMed 37654670

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fecal microbiota transfer in people with Fecal Microbiota Transplantation, run by MaaT Pharma at 16 sites in 3 countries.

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 5 inclusion and 13 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: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France, Poland, Italy. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of FMT in the treatment of Steroid Refractory -Gastro-intestinal Acute GVHD (SR-GI-aGVHD) at D28 post inclusion (time frame: up to 4 weeks post inclusion). 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 NCT03359980, which also lists 1 linked publication.

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 23 Feb 2021.

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