Oncology · Medical Literature
Del immune V and microbiome restructuring in colorectal cancer surgery: a randomized double blind placebo controlled trial.
Abstract
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. 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. 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). 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.
Clinical relevance
Colorectal cancer (CRC) patients undergoing surgical resection experience significant perioperative immunosuppression and gut microbiome disruption, both of which may adversely affect recovery and oncologic outcomes. This Phase I randomized double-blind placebo-controlled trial addresses the underexplored role of metabiotic supplementation (Del-Immune V, derived from Lactobacillus rhamnosus) in modulating the gut microbiome and systemic inflammation during the perioperative window. Given the growing evidence linking gut dysbiosis and immune dysregulation to CRC carcinogenesis and surgical morbidity, this study provides timely, clinically actionable data for oncology and colorectal surgery teams.
Key findings
1. Del-Immune V (200 mg/day: two 100 mg capsules) significantly reduced IL-6 compared to placebo (p=0.012), indicating measurable attenuation of perioperative systemic inflammation. 2. A supportive decline in CRP was observed in the treatment arm, though the abstract does not report a discrete p-value or effect size for this endpoint specifically. 3. The gut dysbiosis index showed statistically significant improvement in the Del-Immune V group (p=0.024), reflecting a meaningful shift toward a more favorable microbial ecology. 4. Microbiome profiling (16S rRNA sequencing with PICRUSt-based functional inference) demonstrated enrichment of short-chain fatty acid (SCFA)-producing genera — Bifidobacterium, Agathobacter, Gemmiger, and Phocaeicola — in the treatment group, which are associated with mucosal barrier integrity and anti-inflammatory signaling. 5. CRC-associated taxa, notably Fusobacterium, declined in the Del-Immune V arm, suggesting a potential reduction in pro-tumorigenic microbial burden during the perioperative period. 6. Patient-reported quality-of-life outcomes, assessed via the validated EORTC QLQ-C30 questionnaire, improved across multiple functional and symptom domains in the treatment group, though specific domain scores and between-group effect sizes are not quantified in the abstract.
Practice implications
Colorectal cancer patients scheduled for elective resection may benefit from perioperative adjunctive supplementation with Del-Immune V (200 mg/day initiated 7–15 days preoperatively and continued through 15 days postoperatively), based on its demonstrated immunomodulatory effects and favorable microbiome restructuring profile. Clinicians should prioritize this intervention particularly in patients with evidence of preoperative dysbiosis or elevated inflammatory markers (IL-6, CRP), where immune optimization before surgery may translate to improved recovery trajectories. As a Phase I trial with a modest sample size (n=39) and no reported serious adverse events, Del-Immune V appears safe for perioperative use, but larger Phase II/III trials with survival and recurrence endpoints are needed before this can be incorporated into standard oncologic care pathways.