The safety and feasibility of probiotics in children and adolescents undergoing hematopoietic cell transplantation

Abstract

Hematopoietic cell transplantation (HCT) has become a standard treatment for many adult and pediatric conditions. Emerging evidence suggests that perturbations in the microbiota diversity increase recipients' susceptibilities to gut-mediated conditions such as diarrhea, infection and acute GvHD. Probiotics preserve the microbiota and may minimize the risk of developing a gutmediated condition; however, their safety has not been evaluated in the setting of HCT. We evaluated the safety and feasibility of the probiotic, Lactobacillus plantarum (LBP), in children and adolescents undergoing allogeneic HCT. Participants received oncedaily supplementation with LBP beginning on day − 8 or − 7 and continued until day +14. Outcomes were compliance with daily administration and incidence of LBP bacteremia. Administration of LBP was feasible with 97% (30/31, 95% confidence interval (CI) 83-100%) of children receiving at least 50% of the probiotic dose (median 97%; range 50-100%). We did not observe any case of LBP bacteremia (0% (0/30) with 95% CI 0-12%). There were not any unexpected adverse events related to LBP. Our study provides preliminary evidence that administration of LBP is safe and feasible in children and adolescents undergoing HCT. Future steps include the conduct of an approved randomized, controlled trial through Children's Oncology Group.

The intestinal microbiota in allogeneic hematopoietic cell transplant and graft-versus-host disease

“…53, 94 Assessment of the safety of Lactobacillus administration to human HCT patients has shown promising results 95 but the impact on GVHD development has yet to be reported. Although the use of these treatments seem promising, future studies should clarify both the safety and efficiency for these therapies in the clinical setting.…”

Gastrointestinal Graft-versus-Host Disease Is a Risk Factor for Postengraftment Bloodstream Infection in Allogeneic Hematopoietic Stem Cell Transplant Recipients

“…Second, correcting intestinal dysbiosis is critically important, although only a report [34] demonstrated that intestinal dysbiosis was associated with subsequent bacteremia. Prophylactic administration of Lactobacillus plantarum (probiotics) has proven to be safe and feasible in children and adolescents undergoing allo-HSCT [35], whereas another randomized clinical trial using Lactobacillus rhamnosus GG failed to alter the intestinal microbiome and GVHD incidence [36]. In addition, several case reports have suggested that the probiotic itself caused septicemia in highly immunocompromised HSCT recipients [37][38][39].…”

Gut microbiota and hematopoietic stem cell transplantation: where do we stand?

“…Safety and feasibility were demonstrated and, most of all, no cases of L. Plantarum bacteremia were observed. 85 FMT consists of the introduction of a fecal suspension derived from a healthy donor. It was successfully in a patient with recurrent Clostridium difficile-associated disease.…”