Efficacy and Safety of Synbiotics in Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation: A Randomized, Double-blinded, Placebo-controlled Pilot Study

Abstract

Objective High-dose chemotherapy with autologous hematopoietic stem cell transplantation (auto-HSCT) is an effective treatment option for relapsed and refractory aggressive malignant lymphoma. However, patients frequently experience treatment-induced gastrointestinal symptoms. Synbiotics, including live microorganisms and nondigestible food ingredients, reportedly ameliorate chemotherapy-induced mucosal damage. In this study, we assessed the efficacy and safety of synbiotics in patients undergoing auto-HSCT. Methods This randomized, double-blinded study included patients with malignant lymphoma eligible for auto-HSCT. The patients were randomly assigned to either a synbiotic group receiving Bifidobacterium longum (BB536) and guar gum or a placebo group receiving a placebo containing dextrin. The supplements were administered twice daily from the start of conditioning chemotherapy up to 28 days after auto-HSCT. The primary endpoint was the duration of total parenteral nutrition (TPN). Results In total, 12 patients were included and randomized. The median duration of TPN was 15 (range, 12-33) days in the synbiotic group and 17.5 (range, 0-32) days in the placebo group. The median duration of grade ! 3 diarrhea was shorter in the synbiotic group than in then placebo group (2.5 vs. 6.5 days), as was the duration of hospital stay (31.5 vs. 43 days). The oral intake and quality of life regarding diarrhea and anorexia improved in the synbiotic group after engraftment. Synbiotic infections, including bacteremia, were not observed. Conclusion Synbiotics may reduce gastrointestinal toxicity, thereby reducing nutritional problems and improving the quality of life of patients undergoing auto-HSCT, without severe adverse events.

A study of pharmacists-joint total parenteral nutrition in haematopoietic cell transplantation in accord with diagnosis related groups: A retrospective clinical research

“…BEE of patients was calculated according to Harris-Benedict formula. The adjusted body weight of overweight patients with BMI > 24 kg/m 2 was calculated using the following formula (Mizutani et al, 2023 ): …”

Hematopoietic Stem Cell: Regulation and Nutritional Intervention

“…Synbiotics, a mixture of live microorganisms and substrate (s) selectively utilized by host microorganisms confers a health benefit on the host [84], and it reportedly ameliorates chemotherapy-induced mucosal damage. One RCT experiment demonstrated that the intake of Bifidobacterium longum (BB536) and guar gum significantly attenuated diarrhea and anorexia after engraftment, indicating that synbiotics attenuated gastrointestinal toxicity effects [85]. Although many studies have reported the beneficial effects of prebiotics and probiotics on bone marrow transplantation, the direct influence of prebiotics and probiotics on HSCs needs to be elucidated.…”