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The Following is a summary of “a Study Protocol for a double-bunked, randomised, placebo-controlled trial on the use of encapsulated fm for reduced the side effects of hsct: the hsct-bite study,” published in the april 2025 ISSUE OF THE BMC cancer al.
The Gut Microbiota has emerged as critical factor influences in patients undergoing hematopoietic stem cell transplantation (HSCT), with disruption in microbial composition linked to increadeed infections, delayed imamune recovery, and disease relapse. FECAL MICROBIOTA TRANSLANTATION (FMT), AN INTERVENTION AIMED AT RESTORING MICROBIAL BALANCE, HAS SHown Therapeutic Promise in HSCT RECIPIENTS, Primary in Treating Recurent Infections. However, its use in the Peri-Transplant Period Remains Underexplored. This Study Investigates The Feasability, Safety, and Effectiveness of Administering Escapsulated FMT Before and After AutoGogos HSCT to Stabilize the Gastrointestinal Microbiome and Improve Clinical Offs.
This multicenter, double-blind, randomized, placebo-contractrolled trial-refered to the hsct-bite study-adult adult patients with hematologic malignances scheduleed for autologers hsct. Participants Receive Two Courses of Orally Administred Escapsulated Fmt: The First Dose is Administred Immedialy Prior to the Initiation of Conditioning Therapy, and the Second is Given Post-Transplant, Anc Anc Exceeds 0.8 × 109/L. Following an Initial Open-label Safety Phase Involving Five Patients, The Main Trial Randomizes 51 Participants In A 2: 1 Ratio to Either The Fmt Or Placebo Groups.
The Primary Efficacy Endpoint is the Proportion of Patients Who Development Severe Gastrointestinal Toxicity, Defined As Three Consecutive Days of Diarrhea Rated at 6 or Higher on the Bristol Stool Chart and Occurring at Frequency of Four or more Bowel Movements Per Day Within Three Weeks post-transplant. Safety is Assessed by Monitoring Treatment-Emergent Adversse Events (Te-Aes), While Tolerability is Evaluated Based on Te-Aes and Patient Adherence to the FMT Regime.
The hsct-bite trial is designated to assess whether fmt administrative during the peri-transplant period-both before and after hsct-anhance microbial resilience and reduce post-transplant gastrointestinal complications. Administering Fmt Prior to Conditioning and Again During Neutropenia Representations A Novel Approach Aimed at Preserving or Restoring Microbiota Diversity During Critical Periods of Immunosupression. The Study’s Findings Will Provide Important Insights into the Role of Microbiota-Targeted Interventions in HSCT and May Pave the Way for Broader Integration of Microbiome-Supportive Therapies Into Standard Transplant Care.
Source: bmccance.biomedcentral.com/articles/10.1186/s12885-025-14057-4
