Using fecal microbiotherapy to prevent complications after stem cell transplants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IIb trial evaluates the effectiveness of pooled allogeneic fecal microbiotherapy, MaaT033, in improving survival rates by preventing complications associated with allogeneic hematopoietic cell transplantation (alloHCT). The study is randomized and placebo-controlled, meaning participants will be assigned to receive either the treatment or a placebo. Eligible patients are those aged 50 and older with specific hematologic malignancies who meet certain health criteria. The trial aims to assess the safety and efficacy of this innovative approach in a vulnerable patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 50 years old
* Presence of a hematologic malignancy for which an alloHCT is indicated with a reduced toxicity or reduced intensity conditioning regimen
* Patients with polynuclear neutrophils \> 0.5 G/L
* Patients having received wide spectrum antibiotics within the last 90 days prior to inclusion
* Karnofsky index ≥ 70%
* Availability of a sibling donor, an unrelated stem-cell donor or a familial haploidentical donor
* Written informed consent

Exclusion Criteria:

* Patients planned to receive a non-myeloablative conditioning regimen (2 Gray total body irradiation (TBI) +/- purine analog, fludarabine + cyclophosphamide or equivalent)
* Patients planned to receive a conventional myeloablative conditioning regimen (e.g. high dose cyclophosphamide and high dose TBI (≥10Gy); high dose busulfan (12.8 mg/kg IV) + high dose cyclophosphamide)
* Patients receiving a manipulated graft (in-vitro T-cell depletion)
* Patients planned to receive a conditioning regimen with alemtuzumab
* Patients planned to receive alloHCT with cord blood cells
* Patients planned to receive alloHCT from unrelated donor with \>= 3/10 HLA-mismatches
* Patients receiving a large spectrum antibiotic at time of randomization
* Patients planned to receive vedolizumab or abatacept for GvHD prophylaxis
* Creatinine clearance \<30 mL/min
* Bilirubin or amino-transferases abnormalities contra-indicating alloHCT
* Cardiac ejection fraction less than 40%
* Pulmonary impairment with \<50% lung carbon monoxide diffusing capacity (DLCO)
* Pregnancy
* Confirmed or suspected intestinal ischemia
* Confirmed or suspected toxic megacolon or gastrointestinal perforation
* Any history of gastro-intestinal surgery in the past 3 months
* Any history of chronic digestive disease (Crohn's disease, ulcerative colitis, inflammatory bowel disease or other relevant digestive condition according to physician's judgement)
* Known allergy or intolerance to trehalose or maltodextrin
* Patients with EBV-IgG negative serology
* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
* Vulnerable patients such as: persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention.

Where it's running

• Universitair Ziekenhuis Antwerpen
  Antwerp, Belgium Recruiting
• AZ Sint - Jan Brugge
  Bruges, Belgium Recruiting
• Institut Jules Bordet
  Brussels, Belgium Recruiting
• Universitair Ziekenhuis Brussel
  Brussels, Belgium Recruiting
• Universitair Ziekenhuis Gent
  Ghent, Belgium Recruiting
• Cliniques Universitaires Saint-Luc
  Leuven, Belgium Recruiting

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Florent Malard, MD, PhD — Aphp
• Study coordinator: Emilie Plantamura, PharmD, PhD
• Email: eplantamura@maat-pharma.com
• Phone: 0033 663590186

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cardiovascular outcomes after hematopoietic stem cell transplantation

  We will collect clinical, laboratory, and treatment data from people who had hematopoietic stem cell transplants to see if certain factors are linked to heart and blood vessel problems after transplant.

  Recruiting at 16 sites Peking University People's Hospital · Beijing, Beijing Municipality and 15 other locations · NCT07349498

• Negative-pressure wound dressing after kidney transplant

  This study tests whether using a negative-pressure wound dressing right after open kidney transplant reduces wound problems for adult transplant recipients.

  Recruiting Phase 4 Centro Hospitalar De São João, E.P.E. · Porto · NCT07065734

• Comparing two types of fascia for skull base reconstruction after surgery

  This study is testing whether using fascia from the thigh or from the temple is better for repairing the skull base after surgery for certain tumors, to see which one leads to less pain and fewer complications for patients.

  Recruiting Klinički Bolnički Centar Zagreb · Zagreb · NCT06493812

• Observational study on infections in transplant patients in Germany

  This study looks at how infections affect transplant patients in Germany to see what makes some people more likely to get infections and how it impacts their organ health over time.

  Recruiting Technical University of Munich · München · NCT06346665

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.