At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pooled allogeneic fecal microbiotherapy (drug), Placebo (drug)
- How long the study runs
- Study runs about 40 months (dates as stated)
- About the drug or intervention
- Pooled allogeneic fecal microbiotherapy — drug: Capsule for oral use · Placebo — drug: Capsule for oral use
- Patient visit burden
- Not specified by the sponsor
In plain English
The PHOEBUS trial is testing a pooled stool (faecal) microbiotherapy given by mouth to help prevent complications after a type of stem cell transplant called allogeneic haematopoietic cell transplantation. It is for people aged 50 or over with a blood cancer for whom this transplant is planned. The sponsor is MaaT Pharma.
Who can take part
- Age 50 or over
- Have a blood cancer for which this type of stem cell transplant is planned, using a reduced-toxicity or reduced-intensity preparation regimen
- A certain level of white blood cells called neutrophils (more than 0.5 G/L)
- Have had broad-spectrum antibiotics in the last 90 days
- Able to carry out daily activities (Karnofsky score of 70% or more)
- Have a suitable donor: a brother or sister, an unrelated donor, or a partly matched family donor
- Give written informed consent
Who may not be able to
- Planned to receive either a very mild (non-myeloablative) or a very strong (myeloablative) preparation regimen
- Receiving a graft that has been specially treated to remove T cells
- A preparation regimen that includes a medicine called alemtuzumab
- A transplant using cord blood cells
- An unrelated donor with 3 or more out of 10 tissue type (HLA) mismatches
- Taking a broad-spectrum antibiotic at the time of joining the trial
- Planned treatment with vedolizumab or abatacept to prevent graft-versus-host disease
- Severely reduced kidney function (creatinine clearance under 30 mL/min)
- Liver blood test results that would rule out the transplant
- Heart pumping function below 40%
- Lung function below 50% on a breathing test (DLCO)
- Pregnancy
- Confirmed or suspected lack of blood flow to the bowel
- Confirmed or suspected toxic megacolon (very swollen bowel) or a hole in the bowel
- Bowel surgery in the past 3 months
- A long-term digestive condition such as Crohn's disease, ulcerative colitis or another inflammatory bowel disease
- Known allergy or intolerance to trehalose or maltodextrin
- Testing negative for a past glandular fever virus infection (EBV, checked by an antibody blood test)
- Any condition that, in the researcher's view, would stop full participation, cause significant risk, or affect the study results
- People in vulnerable situations, such as those detained or in intensive care and unable to give informed consent
What taking part involves
- • Taking a pooled faecal microbiotherapy (a treatment made from gut bacteria) by mouth
Time commitment: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 50 Years and over
- Who
- All
- Number of participants
- 387
- Started
- 2023-10-31
- Last checked
- 2024-12
Plain English Summary
What is this study?
- • Testing a new treatment for transplant complication
- • Phase2 - 387 participants
- • This randomized, placebo-controlled phase IIb study (PHOEBUS trial) aims to evaluate the activity of fecal microbiotherapy MaaT033 to improve survival through the prevention of transplant-related complications in eligible alloHCT patients
Who can take part?
- • Ages 50 Years and over
- • Diagnosed with transplant complication
Where?
- • Cardiff - Cardiff and Vale University Health Board
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This randomized, placebo-controlled phase IIb study (PHOEBUS trial) aims to evaluate the activity of fecal microbiotherapy MaaT033 to improve survival through the prevention of transplant-related complications in eligible alloHCT patients
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Age ≥ 50 years old
- ✓Presence of a blood cancer for which an alloHCT is indicated with a reduced toxicity or reduced intensity...
- ✓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%
Who cannot take part
- ✗Patients planned to receive a non-myeloablative conditioning regimen (2 Gray total body irradiation (TBI) +/- purine...
- ✗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
See the full criteria
Where Is This Study? (1 UK site)
Cardiff and Vale University Health Board
Cardiff, United Kingdom
How to Get in Touch
Emilie Plantamura, PharmD, PhD
Sponsor contactCONTACT
Romain Collard
Sponsor contactCONTACT
