Evidence map›Paper›PMID 33303685›Full record

ArticleScience (New York, N.Y.)2021

Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients.

Erez N Baruch, Ilan Youngster, Guy Ben-Betzalel, Rona Ortenberg, Adi Lahat, Lior Katz, Katerina Adler, Daniela Dick-Necula, Stephen Raskin, Naamah Bloch and 22 more

3 registry-linked trialsAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Science (New York, N.Y.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1,049 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,049citing papers in PubMed, 9 pooled it
20.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04758507 phase1 / phase2completednot on this map

Targeting Gut Microbiota to Improve Efficacy of Immune Checkpoint Inhibitors in Patients With Advanced Renal Cell Carcinoma

TypeinterventionalSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2021 to 2025Enrolled50ConditionsRenal Cell CarcinomaArmsdonor FMT, Placebo FMT
NCT05502913 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Fecal Microbiota Transplantation to Improve Efficacy of Immune Checkpoint Inhibitors in Metastatic Lung Cancer

TypeinterventionalSponsorSoroka University Medical CenterRan2023 to 2028Enrolled80ConditionsMetastatic Lung CancerArmsAntibiotics, FMT (Fecal Microbiota Transplantation)
NCT06992453 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Disentangling Microbiome Engraftment by Multi-omics of the Gut Ecosystem During Fecal Transplant

TypeinterventionalSponsorCatholic University of the Sacred HeartRan2026 to 2029Enrolled90ConditionsRecurrent C. Difficile (rCDI), Ulcerative Colitis (UC), Metabolic Syndrome (MetS)ArmsFecal microbiota transplantation (FMT)
3 · Its place in the literature

Who cites it

1,049 citing papers in PubMed, 9 syntheses or guidelines pooled it, 1,516 citations in OpenAlex.

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  10. Science advances · 2026
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989 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

32 authors at 7 institutions in 2 countries.

Erez N BaruchThe Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Tel-HaShomer, Israel. erezbaruch@mail.tau.ac.il gal.markel@sheba.health.gov.il.ORCID https://orcid.org/0000-0001-6001-6598
Ilan YoungsterPediatric Division and the Microbiome Research Center, Shamir (Assaf Harofeh) Medical Center, Be'er Ya'akov, Israel.ORCID https://orcid.org/0000-0001-5233-1213
Guy Ben-BetzalelThe Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Tel-HaShomer, Israel.
Rona OrtenbergThe Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Tel-HaShomer, Israel.ORCID https://orcid.org/0000-0002-3472-431X
Adi LahatDepartment of Gastroenterology, Sheba Medical Center, Tel HaShomer, Israel.
Lior KatzDepartment of Gastroenterology, Hadassah Medical Center, Jerusalem, Israel.
Katerina AdlerDepartment of Mathematics, Bar Ilan University, Ramat Gan, Israel.ORCID https://orcid.org/0000-0001-5769-8284
Daniela Dick-NeculaInstitute of Pathology, Sheba Medical Center, Tel-HaShomer, Israel.
Stephen RaskinSchool of Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.ORCID https://orcid.org/0000-0002-3549-0594
Naamah BlochAzrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.
Daniil RotinInstitute of Pathology, Sheba Medical Center, Tel-HaShomer, Israel.ORCID https://orcid.org/0000-0003-3386-0077
Liat AnafiInstitute of Pathology, Sheba Medical Center, Tel-HaShomer, Israel.
Camila AviviInstitute of Pathology, Sheba Medical Center, Tel-HaShomer, Israel.
Jenny MelnichenkoThe Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Tel-HaShomer, Israel.ORCID https://orcid.org/0000-0002-2332-0088
Yael Steinberg-SilmanThe Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Tel-HaShomer, Israel.ORCID https://orcid.org/0000-0002-2003-5062
Ronac MamtaniDivision of Hematology and Oncology, University of Pennsylvania, Philadelphia, PA, USA.
Hagit HaratiThe Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Tel-HaShomer, Israel.ORCID https://orcid.org/0000-0002-4840-9994
Nethanel AsherThe Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Tel-HaShomer, Israel.ORCID https://orcid.org/0000-0002-4094-8045
Ronnie Shapira-FrommerThe Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Tel-HaShomer, Israel.ORCID https://orcid.org/0000-0001-6170-080X
Tal Brosh-NissimovInfectious Diseases Unit, Assuta Ashdod University Hospital, Ashdod, Israel.
Yael EshetSchool of Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.ORCID https://orcid.org/0000-0002-8339-5823
Shira Ben-SimonAzrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.
Oren ZivAzrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.
Md Abdul Wadud KhanProgram for Innovative Microbiome and Translational Research, Department of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID https://orcid.org/0000-0001-5258-240X
Moran AmitDepartment of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nadim J AjamiProgram for Innovative Microbiome and Translational Research, Department of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID https://orcid.org/0000-0002-3808-8576
Iris BarshackSchool of Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Jacob SchachterThe Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Tel-HaShomer, Israel.
Jennifer A WargoProgram for Innovative Microbiome and Translational Research, Department of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID https://orcid.org/0000-0003-3438-7576
Omry KorenAzrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.ORCID https://orcid.org/0000-0002-7738-1337
Gal Markel *The Ella Lemelbaum Institute for Immuno-Oncology, Sheba Medical Center, Tel-HaShomer, Israel. erezbaruch@mail.tau.ac.il gal.markel@sheba.health.gov.il.ORCID https://orcid.org/0000-0003-4835-891X
Ben Boursi *School of Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.ORCID https://orcid.org/0000-0002-1304-8340
Sheba Medical Center · ILTel Aviv University · ILBar-Ilan University · ILThe University of Texas MD Anderson Cancer Center · USAssuta Medical Center · ILHadassah Medical Center · ILUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The gut microbiome has been shown to influence the response of tumors to anti-PD-1 (programmed cell death-1) immunotherapy in preclinical mouse models and observational patient cohorts. However, modulation of gut microbiota in cancer patients has not been investigated in clinical trials. In this study, we performed a phase 1 clinical trial to assess the safety and feasibility of fecal microbiota transplantation (FMT) and reinduction of anti-PD-1 immunotherapy in 10 patients with anti-PD-1-refractory metastatic melanoma. We observed clinical responses in three patients, including two partial responses and one complete response. Notably, treatment with FMT was associated with favorable changes in immune cell infiltrates and gene expression profiles in both the gut lamina propria and the tumor microenvironment. These early findings have implications for modulating the gut microbiota in cancer treatment.

Indexed as

Gastrointestinal MicrobiomeAdultAntineoplastic Agents, ImmunologicalCD8-Positive T-LymphocytesFecal Microbiota TransplantationFemaleHumansImmunotherapyIntestinal MucosaLymphocytes, Tumor-InfiltratingMaleMelanomaMiddle AgedNivolumabProgrammed Cell Death 1 ReceptorSkin NeoplasmsAntineoplastic Agents, ImmunologicalNivolumabProgrammed Cell Death 1 Receptor

Identifiers

PMID33303685
OpenAlexW3111836013

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.