Systematic Review · e0001
Personalized microbiome biotherapeutics: a systematic review of clinical evidence
Marat Shoranov, Shynar Tanabayeva, Olga Vasileva, Altynay Sadykova. Personalized microbiome biotherapeutics: a systematic review of clinical evidence. Global Medical Reviews. 2026;1(1):5–25.
Abstract
Background
Personalized microbiome biotherapeutics may tailor donor, product, recipient, ecological conditioning, or monitoring. This review assessed human evidence across recurrent Clostridioides difficile infection (CDI), cancer immunotherapy, ulcerative colitis, and multidrug-resistant organism (MDRO) decolonization, distinguishing validated personalization from protocol standardization.
Methods
PRISMA 2020 guided a narrative synthesis. PubMed/MEDLINE, CENTRAL, ClinicalTrials.gov, regulatory sources and citation searching were searched to 2 February 2026. Two reviewers screened records and extracted data independently. Risk of bias and certainty of evidence were appraised descriptively rather than through formal RoB 2, ROBINS-I or GRADE procedures, and no meta-analysis was performed. The review was not prospectively registered.
Results
Twenty-seven unique studies (28 reports) were retained: 7 recurrent-CDI, 8 oncology, 7 ulcerative-colitis, and 5 MDRO studies. Four used prospective donor or protocol selection beyond routine criteria, 14 were personalization-enabling, and 9 were non-personalized comparators. Standardized products produced the most consistent recurrent-CDI benefit. Responder-donor FMT and defined microbial consortia showed signals in oncology, ulcerative-colitis results varied, and MDRO evidence remained limited. No validated patient-level donor-recipient matching algorithm was found.
Conclusions
Evidence supports indication- and protocol-level tailoring, not routine patient-specific matching. Prospective comparative trials should prespecify allocation rules, analytical validation, clinically important outcomes, and safety surveillance.
Keywords
Article history
- Received
- Revised
- Accepted
- First published online
Peer-review model: Double-blind external peer review · Version: Version of Record
Supplementary materials
Supplementary tables and materials are included within the Version of Record PDF and HTML full text where present.