Exploring gut microbiota changes in patients with steroid refractory GvHD receiving MaaT013
PrOspective inteRventional Study Exploring the mIcrobiota recolONization in Steroid-Refractory Graft-versus-Host Disease Patients Receiving MaaT013
This study is testing if a special enema called MaaT013 can help improve gut health and the immune system in adults with severe graft-versus-host disease that doesn't respond to steroids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | MaaT Pharma Industry-sponsored |
| Locations | 9 sites (Amiens and 8 other locations) |
| Trial ID | NCT05017688 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate how the administration of MaaT013, a microbiome-based enema formulation, affects the gut microbiota composition and immune system in patients suffering from steroid refractory acute graft-versus-host disease (GvHD). Patients aged 18 and older with Grade III-IV GvHD involving the gut will receive MaaT013 as part of a named-patient use program. Blood and stool samples will be collected at each visit to monitor changes and assess the treatment's impact. The study is designed to provide insights into the potential benefits of microbiota recolonization in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Grade III-IV acute GvHD involving the gut who are receiving MaaT013.
Not a fit: Patients who are pregnant, breastfeeding, or unable to provide informed consent due to vulnerability will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with severe GvHD by restoring gut microbiota balance.
How similar studies have performed: Other studies have shown promise in using microbiome-based therapies for GvHD, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Amiens and 8 other locations
- Chu Amiens Picardie Site Sud — Amiens, France (Recruiting)
- Chu de Caen — Caen, France (Recruiting)
- Chu Grenoble — Grenoble, France (Recruiting)
- Chu de Nice - L'Archet 1 — Nice, France (Recruiting)
- Aphp - Hopital Saint Antoine — Paris, France (Recruiting)
- Chu Lyon Sud — Pierre-Bénite, France (Active_not_recruiting)
- Chu La Miletrie — Poitiers, France (Recruiting)
- Chu de Rennes - Hopital Pontchaillou — Rennes, France (Active_not_recruiting)
- Institut Universitaire Du Cancer de Toulouse - Oncopole — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Sarah Guenounou, MD — Iuct Oncopole
- Study coordinator: Juliette JOUVE
- Email: orion@maat-pharma.com
- Phone: +33 4 28 29 14 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.