Del-Immune V and microbiome restructuring in colorectal cancer surgery: a randomized double-blind placebo-controlled trial
Perioperative supplementation with Del-Immune V (a L. rhamnosus-derived metabiotic) significantly reduced IL-6 and altered microbiome composition in colorectal cancer patients undergoing elective resection.
| Population | — |
|---|---|
| Intervention | — |
| Comparator | — |
| Outcome | — |
What the study showed
The Del-Immune V group showed significant reduction in IL-6 (p=0.012) and a decline in CRP, alongside improvement across multiple quality-of-life domains on the EORTC QLQ-C30. Microbiome analysis revealed enrichment of short-chain fatty acid-producing genera (Bifidobacterium, Agathobacter, Gemmiger, Phocaeicola) and decline of other taxa not detailed in the abstract.
How it was done
Phase I randomized, double-blind, placebo-controlled trial in 39 colorectal cancer patients (Del-Immune V n=22; placebo n=17), receiving two capsules daily (100 mg each) from 7–15 days preoperatively through 15 days postoperatively. Blood and fecal samples were collected at baseline and day 60; microbiome profiled by 16S rRNA gene sequencing with PICRUSt-based functional inference.
Risk of bias
Very small sample size (n=39) with group asymmetry (22 vs 17) limits statistical power and generalizability. This is a Phase I trial, primarily designed for safety assessment rather than efficacy; the abstract does not specify declining taxa or oncological clinical outcomes.
What this study does NOT prove
The study does not demonstrate oncological clinical benefit (survival, recurrence) nor establishes causality between microbiome modification and the observed outcomes.
In clinical practice
Findings are preliminary and insufficient to support clinical recommendations for perioperative use of Del-Immune V in oncology. Phase II/III trials with larger samples and primary clinical endpoints are required.
Limitations
Very small sample size (n=39) with group asymmetry (22 vs 17) limits statistical power and generalizability. This is a Phase I trial, primarily designed for safety assessment rather than efficacy; the abstract does not specify declining taxa or oncological clinical outcomes.
Technical appendix
Version history
- 1.0 · 2026-07-23 — Auto-generated under Evidence Standard v1.0
Paid access: structured summary from public metadata; consult the original study at the source.