Acute Lymphoblastic LeukaemiaPhase 2MASTNCT06355583
Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial
A Phase 2 study testing EBX-102 in people with Acute Lymphoblastic Leukaemia and Acute Leukemia of Ambiguous Lineage, run by Imperial College London at 8 sites in United Kingdom.
Trial summary
The goal of this clinical trial is to test the ability to restore gut microbiota to healthier levels in patients with blood cancers scheduled to have stem cell transplant. The main questions it aims to answer are: Tolerability and acceptability of intestinal microbiota transplantation (IMT) versus placebo (as assessed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukaemia, Acute Leukemia of Ambiguous Lineage, Chronic Myeloid Leukemia
- What is being tested?
- EBX-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 1 May 2024to 1 May 2027
- Phase
- Phase 2
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 aged 18 years and over with a morphological documented diagnosis of ALL, acute myeloid leukemia (AML), AL of ambiguous lineage, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and CML in blast phase (Appendix 2) who are deemed fit for allogenic HCT with one of the following disease characteristics: ALL, AML, AL of ambiguous lineage
- Patients in first complete remission (CR1) or second complete remission (CR2) including complete remission with incomplete blood count recovery with < 5% blasts (Appendix 2)
- Secondary leukaemia (defined as previous history of MDS, antecedent haematological disease or chemotherapy exposure) in CR1 or CR2 defined as < 5% blasts (Appendix 2) MDS and CMML
- Patients with advanced or high risk MDS with an International Prognostic Scoring System (IPSS-M) moderate high or higher including intermediate or high risk CMML who have < 5% blasts at the time of randomisation (Appendix 2) CML in blast phase
- Patients with Philadelphia or BCR:ABL1 positive chronic myeloid leukaemia (CML) in blast phase defined by the presence of ≥ 20% blasts in blood or bone marrow who have achieved second chronic phase with < 5% blasts (Appendix 2).
- Patients must have completed minimum of two cycles of intensive chemotherapy prior to trial enrolment (Appendix 1)
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- Patients must have received broad-spectrum antibiotics within 3 months prior to trial enrolment
- Patients must be considered suitable/fit to undergo allogeneic hematopoietic cell transplantation (HCT) as clinically judged by the Local investigator
- Patients with an Karnofsky performance status score 60 or above (Appendix 3)
- Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must use appropriate, highly effective, contraception from the point of commencing therapy until 6 months after treatment
- Patients have given written informed consent
- Patients willing and able to comply with scheduled study visits and laboratory tests
Who cannot join
- Patients with contraindications to receiving allogeneic HCT.
- Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before commencing treatment.
- Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period.
- Patients with renal or hepatic impairment as clinically judged by the Local Investigator.
- Patients with active infection, HIV-positive or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Patients with a concurrent active malignancy or a prior malignancy, except lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ, incidental histologic finding of prostate cancer (T1a or T1b using the tumour, node, metastasis (TNM) clinical staging system), previous MDS, CMML, Myeloproliferative neoplasms (MPN) resulting in secondary AML. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed.
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- Swallowing difficulties that may preclude safe use of IMT capsules.
- Administration of IMT within 3 months prior to enrolment (probiotic administration prior to enrolment is allowed but should be recorded at screening).
- Patients taking probiotics after enrolment to the trial.
- Gastrointestinal disorders and diseases, including delayed gastric emptying, coeliac disease, cystic fibrosis, inflammatory bowel disease, irritable bowel syndrome, chronic diarrhoea, and colonic perforation or fistula.
- Any autoimmune disease requiring, or that may require, systemic treatment with steroids and/or other immunosuppressants/immunomodulators.
- Significant bleeding disorder (ALL, AML, AL of ambiguous lineage, MDS, CMML, and CML satisfying inclusion criteria are not excluded).
- Anaphylactic food allergy.
- Requirement for vasopressors.
- Valvular heart disease or known structural defects of the heart.
- Known severe allergy to capsule components.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United Kingdom8 sites, 8 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, B15 2WB
Senior Haematology Research Sister, 01213714351, HaematologyCancerResearch@uhb.nhs.uk
Francesca Kinsella
- Not yet recruiting
Leeds Teaching Hospital NHS Trust
Leeds, England, LS9 7TF
Principal Investigator, 01132068561, anjum.khan@nhs.net
- Recruiting
University College London Hospitals NHS Trust
London, England, NW1 2BU
BMT Trials, uclh.bmttrials@nhs.net
Panagiotis Kottaridis
- Recruiting
Kings College NHS Foundation Trust
London, England, SE5 9RS
Principal Investigator, p.krishnamurthy@nhs.net
Pramila Krishnamurthy
- Recruiting
Imperial College Healthcare NHS Trust
London, England, W12 0NN
Senior Research Operations Manager, 02037048452, Eleni.Vourvou@nhs.net
- Recruiting
Royal Mardsen Hostpital
London, SW3 6JJ
Haemato-Oncology Department, 0208915 6187, Emma.Nicholson@rmh.nhs.uk
Emma Nicholson
- Not yet recruiting
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Farshi Pakhshan, 01612761234, Pakhshan.Farshi@mft.nhs.uk
- Recruiting
Manchester University NHS Trust
Manchester, M13 9WL
Fiona Dignan, 0161 276 4178, Alice.Cui@mft.nhs.uk
About this study
The goal of this clinical trial is to test the ability to restore gut microbiota to healthier levels in patients with blood cancers scheduled to have stem cell transplant.
The main questions it aims to answer are:
Read more
- Tolerability and acceptability of intestinal microbiota transplantation (IMT) versus placebo (as assessed via patient perspective questionnaires
- Changes in gut microbiome diversity across all timepoints
- Markers of general health, infective/microbiological and haematological outcomes including, days of fever, admission to intensive care unit, survival, non-relapsed mortality, and incidence of graft-versus-host disease across all time points measured.
Participants will be asked at their routine follow up visits to,
- Provide stool, urine and blood samples at the scheduled study visits
- Complete questionnaires at selected visits
- Swallow either Placebo or IMT capsules once at the second study visit which will occur 2 weeks prior to the stem cell transplant (+/-3 days)
Researchers will compare IMT capsules and Placebo to investigate the change in gut microbiota diversity.
- Conditions
- Acute Lymphoblastic Leukaemia, Acute Leukemia of Ambiguous Lineage, Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Acute Myeloid Leukemia
- Being tested
- EBX-102, Placebo
- Keywords
- MAST
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBX-102Drug
Also called IMT capsules
EBX-102 is a white size 0 gastro-resistant hydroxypropyl methylcellulose (HPMC) capsule containing communities of dried, intestinal microorganisms extracted from rigorously screened pooled human stool samples obtained from volunteer accredited donors.
PlaceboDrug
The capsules contain inactive ingredients microcrystalline cellulose and magnesium stearate.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients randomised on to the placebo arm will swallow 10 placebo capsules once at the second study visit approximately 2 weeks before the stem cell transplantation. The capsules contain inactive ingredients (microcrystalline cellulose and magnesium stearate) and will have the same appearance, weight, and packaging weight to the IMT capsules in the treatment arm to maintain treatment blinding. Receives: Drug: Placebo |
| EBX-102-02 | Active comparator | Patients randomised on to the Treatment arm will swallow 10 capsules once at the second study visit approximately 2 weeks before the stem cell transplantation. Each capsule will contain 1x10^6 - 1x10^9 colony forming units (CFU)/g of viable microorganisms and will have the same appearance, weight and packaging weight to the placebo capsules in the treatment arm to maintain treatment blinding. Receives: Drug: EBX-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut microbiota diversity using Inverse Simpsons Index
Ecological metric to measure diversity in the gut microbiome in samples collected at two time points. It considers both the number of species present (richness) and their relative abundance (evenness). The Inverse index scale ranges from 0-1 with higher ranges indicating higher diversity.
Measured: Screening - up to 42 before stem cell transplantation (HCT) and Assessment 5 - Day 28(+/-3) post stem cell transplantation (HCT)
Secondary outcomes (25)
Gut Microbiome Diversity - Alpha diversity
Measured via changes in Chao-1 , Shannon index and Faith's PD to estimate the richness and functional composition across all timepoints
Measured: All timepoints, Screening up to Day-42, Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Alpha Diversity - Chao1 Index
A non-parametric method for estimating Species Richness: referring to the total number of different species present in the gut microbiome, particularly useful for accounting for undetected species.points
Measured: All timepoints, Screening up to Day-42, Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Alpha Diversity - Shannon Index
An ecological metric used to measure which combines both, Species Richness: referring to the total number of different species present in the gut microbiome.
Species Evenness: this indicates how evenly the species are distributed. A higher index value implies higher evenness and richness.
Measured: All timepoints, Screening up to Day-42, Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Alpha Diversity - Faiths Phylogenetic Diversity (Faiths PD)
An ecological metric used to measure, Species Richness: referring to the total number of different species present in the gut microbiome. Faiths PD also uses the phylogenetic tree of the identified species to measure the total evolutionary distance.
A higher Faith's PD value indicates a wider range of evolutionary diversity
Measured: All timepoints, Screening up to Day-42, Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Beta Diversity - Aitchison Distance
Ecological metric used to compare the distance in compositions in stool samples collected at different time points will with the baseline stool sample. Larger distances might indicate differences in bacterial communities present in the gut microbiome
Measured: All timepoints, Screening up to Day-42, Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Gut Microbiome Taxonomic Composition
Measured using shallow shotgun sequencing which indicates the specific bacterial types and relative abundancies. stool samples collected at different time points will be compared with the baseline stool sample.
Measured: All timepoints, Screening up to Day-42, Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Markers of general health - ITU Admission
Assessed by the total number days spent in an intensive care unit (ITU) from treatment to end of study
Measured: Days Post HCT: Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Quality of life EQ-5D-5L
Quality of live measured by standardised EQ-5D-5L questionnaire which assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a scale from 0 (worst health imaginable) to 100 (best health imaginable
Measured: Screening up to Day-42, Days Post HCT: Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Quality of Life EORTC-QLQ-C30
Quality of life measured by standardised EORTC-QLQ-C3O Questionnaire Contains 30 questions grouped into 15 functional scales. Each scale is scored individually based on the answers, resulting in a score between 0 and 100. A higher score indicates better quality of life in that specific m
Measured: Screening up to Day-42, Days Post HCT: Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Infective Haematological Outcomes - Fever Occurrence
Fever: Rise in body temperature above the normal range 38°C (100.4°F) or higher reported across all study time points post screening.
Measured: All timepoints, Screening up to Day-42, Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Infective Haematological Outcomes - Fever CTCAE Grade
Measured by the number of reported occurrences of grade I - IV following the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading system
Measured: All timepoints, Screening up to Day-42, Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Infective Haematological Outcomes - Infection
Measured by reported occurrences of bloodstream infections and urinary tract infections across all time points.
Measured: All timepoints, Screening up to Day-42, Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Infective Haematological Outcomes - Multi drug Resistant Bacterial Colonisation (MDROs)
Assessed by the number of reported deaths not caused by relapse or progression
Measured: All timepoints, Screening up to Day-42, Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Infective Haematological Outcomes - Antibiotic Use
Measured by reported use of antibiotics to treat an infection diagnosis at all study timepoints.
Measured: All timepoints, Screening up to Day-42, Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Markers of General Health - Severity of Mucositis
Assessed by the number of reported occurrences of mucositis grade III and above following the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading system post stem cell transplantation.
Measured: The outcome will be assessed at Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Markers of General Health -Occurrence of Severe Acute Kidney Injury (AKI)
Assessed by the reported incidence of severe acute kidney post stem cell transplantation.
Measured: The outcome will be assessed at Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Markers of General Health - Occurrence of Severe liver dysfunction
Assessed by the reported incidence of severe liver dysfunction post stem cell transplantation.
Measured: The outcome will be assessed at Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Markers of general health - Use of Parenteral Nutrition
Measured by the reported use of parenteral nutrition treatment post stem cell transplantation
Measured: The outcome will be assessed at Day -7(+/-2), Day 0(+/-1), Day 7(+/-3), Day 14(+/-3), Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Neutrophil and platelet engraftment data
Neutrophil and platelet engraftment data as defined by European Group for Blood and Marrow Transplantation (EBMT) will be routinely collected
Measured: Days Post HCT: Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Recovery of T-cell Chimaerisms,
T-cell count assessed by the lymphocyte subset analysis and immunoglobulin levels will be recorded at follow-up assessments.
Measured: Follow up Assessments: Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Haematological Outcomes - Non-relapsed mortality
Assessed by the number of reported deaths not caused by relapse or progression post stem cell transplantation
Measured: Days Post HCT: Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Haematological Outcomes - Occurrence Graft vs Host Disease
Measured by the reported occurrence of Graft vs Host Disease at all follow up assessments.
Measured: Follow up Assessments: Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Haematological Outcomes - Severity of graft vs Host Disease
Measured using the National Institutes of Health (NIH) Chronic/Acute GvHD Global Severity classification at all follow up assessments.
Measured: Follow up Assessments: Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Overall Survival
Overall Survival (OS) - Measured from the time of the stem cell transplant date to the reporting of death from any cause up to 1 year post stem cell
Measured: Days Post HCT: Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Graft-versus disease-free relapse-free survival
Graft-versus disease-free relapse-free survival (GFRS) - Measured from the time of the stem cell transplant date to the reporting of the first occurrence of either relapse or any grade of graft vs host disease (GVHD)
Measured: Days Post HCT: Day 28(+/-3), Day 100(+/-7), Day 200(+/-7) & Day 365(+/-14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 May 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukaemiaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiri Pavlu, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355583
- Sponsor's protocol ID
- C/42/2022
- Other IDs
- 2022-003617-10
- Acronym
- MAST
- Status last verified
- Apr 2025
- First submitted
- 3 Oct 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymised dataset may be prepared for sharing; a controlled access approach will be followed where data requestors will need to provide information to gain access to the data. The review will be taken by the sponsor and the clinical trials unit for a fully unbiased approach as recommended by the Institute of Medicine. Access to data may be granted but further restrictions regarding the access process may apply e.g. access through a secure web interface." The study protocol will be published as a supplement.
Publications
Sargent DJ, Taylor JM. Current issues in oncology drug development, with a focus on Phase II trials. J Biopharm Stat. 2009;19(3):556-62. doi: 10.1080/10543400902802474.
PubMed 19384696Rubinstein LV, Korn EL, Freidlin B, Hunsberger S, Ivy SP, Smith MA. Design issues of randomized phase II trials and a proposal for phase II screening trials. J Clin Oncol. 2005 Oct 1;23(28):7199-206. doi: 10.1200/JCO.2005.01.149.
PubMed 16192604van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
PubMed 23323867Malard F, Vekhoff A, Lapusan S, Isnard F, D'incan-Corda E, Rey J, Saillard C, Thomas X, Ducastelle-Lepretre S, Paubelle E, Larcher MV, Rocher C, Recher C, Tavitian S, Bertoli S, Michallet AS, Gilis L, Peterlin P, Chevallier P, Nguyen S, Plantamura E, Boucinha L, Gasc C, Michallet M, Dore J, Legrand O, Mohty M. Gut microbiota diversity after autologous fecal microbiota transfer in acute myeloid leukemia patients. Nat Commun. 2021 May 25;12(1):3084. doi: 10.1038/s41467-021-23376-6.
PubMed 34035290Taur Y, Coyte K, Schluter J, Robilotti E, Figueroa C, Gjonbalaj M, Littmann ER, Ling L, Miller L, Gyaltshen Y, Fontana E, Morjaria S, Gyurkocza B, Perales MA, Castro-Malaspina H, Tamari R, Ponce D, Koehne G, Barker J, Jakubowski A, Papadopoulos E, Dahi P, Sauter C, Shaffer B, Young JW, Peled J, Meagher RC, Jenq RR, van den Brink MRM, Giralt SA, Pamer EG, Xavier JB. Reconstitution of the gut microbiota of antibiotic-treated patients by autologous fecal microbiota transplant. Sci Transl Med. 2018 Sep 26;10(460):eaap9489. doi: 10.1126/scitranslmed.aap9489.
PubMed 30257956Peled JU, Gomes ALC, Devlin SM, Littmann ER, Taur Y, Sung AD, Weber D, Hashimoto D, Slingerland AE, Slingerland JB, Maloy M, Clurman AG, Stein-Thoeringer CK, Markey KA, Docampo MD, Burgos da Silva M, Khan N, Gessner A, Messina JA, Romero K, Lew MV, Bush A, Bohannon L, Brereton DG, Fontana E, Amoretti LA, Wright RJ, Armijo GK, Shono Y, Sanchez-Escamilla M, Castillo Flores N, Alarcon Tomas A, Lin RJ, Yanez San Segundo L, Shah GL, Cho C, Scordo M, Politikos I, Hayasaka K, Hasegawa Y, Gyurkocza B, Ponce DM, Barker JN, Perales MA, Giralt SA, Jenq RR, Teshima T, Chao NJ, Holler E, Xavier JB, Pamer EG, van den Brink MRM. Microbiota as Predictor of Mortality in Allogeneic Hematopoietic-Cell Transplantation. N Engl J Med. 2020 Feb 27;382(9):822-834. doi: 10.1056/NEJMoa1900623.
PubMed 32101664van Lier YF, Davids M, Haverkate NJE, de Groot PF, Donker ML, Meijer E, Heubel-Moenen FCJI, Nur E, Zeerleder SS, Nieuwdorp M, Blom B, Hazenberg MD. Donor fecal microbiota transplantation ameliorates intestinal graft-versus-host disease in allogeneic hematopoietic cell transplant recipients. Sci Transl Med. 2020 Aug 12;12(556):eaaz8926. doi: 10.1126/scitranslmed.aaz8926.
PubMed 32801142Shouval R, Geva M, Nagler A, Youngster I. Fecal Microbiota Transplantation for Treatment of Acute Graft-versus-Host Disease. Clin Hematol Int. 2019 Apr 18;1(1):28-35. doi: 10.2991/chi.d.190316.002. eCollection 2019 Mar.
PubMed 34595408DeFilipp Z, Peled JU, Li S, Mahabamunuge J, Dagher Z, Slingerland AE, Del Rio C, Valles B, Kempner ME, Smith M, Brown J, Dey BR, El-Jawahri A, McAfee SL, Spitzer TR, Ballen KK, Sung AD, Dalton TE, Messina JA, Dettmer K, Liebisch G, Oefner P, Taur Y, Pamer EG, Holler E, Mansour MK, van den Brink MRM, Hohmann E, Jenq RR, Chen YB. Third-party fecal microbiota transplantation following allo-HCT reconstitutes microbiome diversity. Blood Adv. 2018 Apr 10;2(7):745-753. doi: 10.1182/bloodadvances.2018017731.
PubMed 29592876Bloom PP, Luevano JM Jr, Miller KJ, Chung RT. Deep stool microbiome analysis in cirrhosis reveals an association between short-chain fatty acids and hepatic encephalopathy. Ann Hepatol. 2021 Nov-Dec;25:100333. doi: 10.1016/j.aohep.2021.100333. Epub 2021 Feb 20.
PubMed 33621653Staley C, Hamilton MJ, Vaughn BP, Graiziger CT, Newman KM, Kabage AJ, Sadowsky MJ, Khoruts A. Successful Resolution of Recurrent Clostridium difficile Infection using Freeze-Dried, Encapsulated Fecal Microbiota; Pragmatic Cohort Study. Am J Gastroenterol. 2017 Jun;112(6):940-947. doi: 10.1038/ajg.2017.6. Epub 2017 Feb 14.
PubMed 28195180Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.
PubMed 28087657Kao D, Roach B, Silva M, Beck P, Rioux K, Kaplan GG, Chang HJ, Coward S, Goodman KJ, Xu H, Madsen K, Mason A, Wong GK, Jovel J, Patterson J, Louie T. Effect of Oral Capsule- vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2017 Nov 28;318(20):1985-1993. doi: 10.1001/jama.2017.17077.
PubMed 29183074Taur Y, Xavier JB, Lipuma L, Ubeda C, Goldberg J, Gobourne A, Lee YJ, Dubin KA, Socci ND, Viale A, Perales MA, Jenq RR, van den Brink MR, Pamer EG. Intestinal domination and the risk of bacteremia in patients undergoing allogeneic hematopoietic stem cell transplantation. Clin Infect Dis. 2012 Oct;55(7):905-14. doi: 10.1093/cid/cis580. Epub 2012 Jun 20.
PubMed 22718773Innes AJ, Mullish BH, Ghani R, Szydlo RM, Apperley JF, Olavarria E, Palanicawandar R, Kanfer EJ, Milojkovic D, McDonald JAK, Brannigan ET, Thursz MR, Williams HRT, Davies FJ, Marchesi JR, Pavlu J. Fecal Microbiota Transplant Mitigates Adverse Outcomes Seen in Patients Colonized With Multidrug-Resistant Organisms Undergoing Allogeneic Hematopoietic Cell Transplantation. Front Cell Infect Microbiol. 2021 Aug 27;11:684659. doi: 10.3389/fcimb.2021.684659. eCollection 2021.
PubMed 34513724