Frontiers in cellular and infection microbiology · 2026
Del immune V and microbiome restructuring in colorectal cancer surgery: a randomized double blind placebo controlled trial.
Клиническое исследование I фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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García Gissel, Díaz Antonio, Fernández LLipsy T, Bernal Mirka, Soto Josanne, Núñez Gilda, Fleites Vilma, Arteaga Ernesto, Sichel Liubov, Cano Raúl de Jesús
Аннотация
INTRODUCTION: The gut microbiome is increasingly recognized as a central factor in carcinogenesis. Dietary components and therapeutic interventions, including probiotics, may influence microbial composition and function, thereby modulating cancer risk. Del-Immune V, a metabiotic supplement derived from Lactobacillus rhamnosus, has demonstrated immunomodulatory properties. This study investigates its role in microbiome restructuring and patient-reported outcomes in colorectal cancer patients during the perioperative period.
MATERIALS AND METHODS: A randomized, controlled, double-blind Phase I trial was conducted in 39 colorectal cancer patients undergoing elective resection, assigned to Del-Immune V (n=22) or placebo (n=17). Participants received two capsules daily (100 mg each), starting 7-15 days before surgery and continuing until 15 days postoperatively. Blood and fecal samples were collected at baseline and day 60 to assess IL-6, CRP, CEA, and microbiome composition. Patient-reported outcomes were measured using the EORTC QLQ-C30 questionnaire. Microbiome profiling was performed using 16S rRNA gene sequencing with PICRUSt-based functional inference.
RESULTS: Del-Immune V significantly reduced IL-6 (p=0.012) and supported CRP decline, while quality-of-life scores improved across multiple domains. Microbiome analyses revealed enrichment of short-chain fatty acid-producing genera (Bifidobacterium, Agathobacter, Gemmiger, Phocaeicola) and decline of CRC-associated taxa (Fusobacterium), with a significant improvement in the dysbiosis index (p=0.024).
CONCLUSIONS: Del-Immune V demonstrated immunomodulatory activity, evidenced by reductions in IL-6 and CRP, alongside improvements in patient-reported quality of life. These effects were accompanied by restructuring of the gut microbiome, characterized by enrichment of protective commensals and reduction of CRC-associated taxa. Collectively, findings support Del-Immune V as a safe adjunctive therapy in colorectal cancer surgery, with potential to enhance recovery and long-term outcomes.
MATERIALS AND METHODS: A randomized, controlled, double-blind Phase I trial was conducted in 39 colorectal cancer patients undergoing elective resection, assigned to Del-Immune V (n=22) or placebo (n=17). Participants received two capsules daily (100 mg each), starting 7-15 days before surgery and continuing until 15 days postoperatively. Blood and fecal samples were collected at baseline and day 60 to assess IL-6, CRP, CEA, and microbiome composition. Patient-reported outcomes were measured using the EORTC QLQ-C30 questionnaire. Microbiome profiling was performed using 16S rRNA gene sequencing with PICRUSt-based functional inference.
RESULTS: Del-Immune V significantly reduced IL-6 (p=0.012) and supported CRP decline, while quality-of-life scores improved across multiple domains. Microbiome analyses revealed enrichment of short-chain fatty acid-producing genera (Bifidobacterium, Agathobacter, Gemmiger, Phocaeicola) and decline of CRC-associated taxa (Fusobacterium), with a significant improvement in the dysbiosis index (p=0.024).
CONCLUSIONS: Del-Immune V demonstrated immunomodulatory activity, evidenced by reductions in IL-6 and CRP, alongside improvements in patient-reported quality of life. These effects were accompanied by restructuring of the gut microbiome, characterized by enrichment of protective commensals and reduction of CRC-associated taxa. Collectively, findings support Del-Immune V as a safe adjunctive therapy in colorectal cancer surgery, with potential to enhance recovery and long-term outcomes.