Evidence mapPaperPMID 42482993Full record

Trial reportFrontiers in cellular and infection microbiology2026

Del immune V and microbiome restructuring in colorectal cancer surgery: a randomized double blind placebo controlled trial.

Gissel García, Antonio Díaz, LLipsy T Fernández, Mirka Bernal, Josanne Soto, Gilda Núñez, Vilma Fleites, Ernesto Arteaga, Liubov Sichel, Raúl de Jesús Cano

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in cellular and infection microbiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Gissel GarcíaGissel García, Pathology Department, Hermanos Ameijeiras Clinical and Surgical Hospital, La Habana, Cuba.
Antonio DíazAntonio Díaz.Statistical and Research Department, Hermanos Ameijeiras Clinical and Surgical Hospital, La Habana, Cuba.
LLipsy T FernándezLllipsy T Fernández Surgery Department, Hermanos Ameijeiras Clinical and Surgical Hospital, La Habana, Cuba.
Mirka BernalMirka Bernal Clinical Laboratory Department, Hermanos Ameijeiras Clinical and Surgical Hospital, La Habana, Cuba.
Josanne SotoJosanne Soto Clinical Laboratory Department, Hermanos Ameijeiras Clinical and Surgical Hospital, La Habana, Cuba.
Gilda NúñezGilda Núñez Surgery Department, Hermanos Ameijeiras Clinical and Surgical Hospital, La Habana, Cuba.
Vilma FleitesVilma Fleites: Oncology Department, Hermanos Ameijeiras Clinical and Surgical Hospital, La Habana, Cuba.
Ernesto ArteagaErnesto Arteaga Pathology Department, Hermanos Ameijeiras Clinical and Surgical Hospital, La Habana, Cuba.
Liubov SichelLiubov Sichel: Stellar Biotics, LLC., Rockleigh, NJ, United States.
Raúl de Jesús CanoRaúl de Jesús Cano, Biological Sciences Department, California Polytechnic State University, San Luis Obispo, CA, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 ( 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.

Indexed as

Colorectal NeoplasmsGastrointestinal MicrobiomeLacticaseibacillus rhamnosusProbioticsAgedC-Reactive ProteinDouble-Blind MethodFecesFemaleHumansInterleukin-6MaleMiddle AgedRNA, Ribosomal, 16SC-Reactive ProteinInterleukin-6RNA, Ribosomal, 16Scolorectal cancer surgerydel-immune Vgut microbiomeimmunomodulationinflammatory biomarkersmetabioticrandomized double-blind trialshort-chain fatty acids

Identifiers

PMID42482993
PMCPMC13384829

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.