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Looking for participantsPhase2

Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

Sponsor: MaaT Pharma

NCT ID: NCT05762211

View on ClinicalTrials.gov ↗

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

Transplant Complication

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

IgG negative

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
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 Is This Study? (1 UK site)

Cardiff and Vale University Health Board

Cardiff, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Martin

research.development@wales.nhs.uk029 2074 6986

How to Get in Touch

Emilie Plantamura, PharmD, PhD

Sponsor contact

CONTACT

0033 663590186 eplantamura@maat-pharma.com

Romain Collard

Sponsor contact

CONTACT

rcollard@maat-pharma.com
Data sourced from ClinicalTrials.gov · Last verified: 2024-12