NCT04131803

Probiotics Combined With Standard Chemotherapy Plus Targeted Therapy in Patients With Metastatic Colorectal Cancer

Status unknown NA Last updated 15 July 2021

What this trial tests

NA trial testing Bifico combined with chemotherapy plus targeted therapy in Unresectable Metastatic Colorectal Cancer in 140 participants. Status unknown.

Timeline

1 October 2021

Primary endpoint
25 November 2022

25 November 2025

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	140
Start date	1 October 2021
Primary completion	25 November 2022
Estimated completion	25 November 2025

Drugs / interventions tested

• Bifico combined with chemotherapy plus targeted therapy — full drug profile →
• chemotherapy plus targeted therapy — full drug profile →

Conditions studied

• Unresectable Metastatic Colorectal Cancer — all drugs for Unresectable Metastatic Colorectal Cancer →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 75, any sex, with Unresectable Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bifico (also known as "bifidobacterium trifidum live powder") is a probiotic preparation that has been marketed and widely used in China. The number of live bacteria of lactobacillus acidophilus and bifidobacterium per gram should not be less than 1.0×107CFU. At present, it is mainly used for diarrhea and abdominal distension caused by intestinal flora imbalance. It can also be used for treating mild to moderate acute diarrhea and chronic diarrhea. Lactobacillus acidophilus and bifidobacteria have been fully proved in basic studies to improve gut microbiological environment and inhibit colorectal cancer. A recent paper published by Nature Biomedical Engineering reported that chemotherapy can effectively enhance the efficacy of colon cancer by regulating intestinal flora. Based on the above evidence, we propose that the current standard chemotherapy plus targeted therapy regimen combined with Bifico can exert a more powerful synergistic anticancer effect. To sum up, this study put forward innovative joint regulating intestinal flora environment with standard chemotherapy and target therapy of new concept and mode, to assess Bifico combined with standard chemotherapy plus targeted therapy compared to standard chemotherapy plus targeted therapy for efficacy and safety of metastatic colorectal cancer, combined with the intestinal flora, probiotics patient blood DNA analysis, etc. New technology, explore flora index correlation with the prognosis of patients' immune system function, and its potential as a predictive marker. It is worth noting that this study will closely combine the current most advanced intestinal flora 16S microbial polymorphism detection and single-cell sequencing technology, so as to truly achieve accurate and individualized treatment, evaluation and prognosis prediction.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut microbiota modulation: a novel strategy for prevention and treatment of colorectal cancer.
   Fong W, Li Q, Yu J. · · 2020 · cited 411× · PMID 32514151 · DOI 10.1038/s41388-020-1341-1
2. The Oral Microbiome and Cancer.
   Irfan M, Delgado RZR, Frias-Lopez J. · · 2020 · cited 235× · PMID 33193429 · DOI 10.3389/fimmu.2020.591088
3. Gut Microbiota in Colorectal Cancer: Biological Role and Therapeutic Opportunities.
   Pandey H, Tang DWT, Wong SH, Lal D. · · 2023 · cited 86× · PMID 36765824 · DOI 10.3390/cancers15030866
4. Colorectal Cancer Immunotherapy: State of the Art and Future Directions.
   Cornista AM, Giolito MV, Baker K, Hazime H, et al · · 2023 · cited 30× · PMID 38098742 · DOI 10.1016/j.gastha.2023.09.007
5. Commensal Microbiota and Cancer Immunotherapy: Harnessing Commensal Bacteria for Cancer Therapy.
   Bae J, Park K, Kim YM. · · 2022 · cited 14× · PMID 35291651 · DOI 10.4110/in.2022.22.e3
6. Progress in the Study of Colorectal Cancer Caused by Altered Gut Microbiota After Cholecystectomy.
   Ma Y, Qu R, Zhang Y, Jiang C, et al · · 2022 · cited 13× · PMID 35282463 · DOI 10.3389/fendo.2022.815999
7. Role of imbalanced gut microbiota in promoting CRC metastasis: from theory to clinical application.
   Fan S, Zhou L, Zhang W, Wang D, et al · · 2024 · cited 8× · PMID 38637851 · DOI 10.1186/s12964-024-01615-9
8. The Local Microbiome in Esophageal Cancer and Treatment Response: A Review of Emerging Data and Future Directions.
   Pandey A, Lieu CH, Kim SS. · · 2023 · cited 5× · PMID 37509225 · DOI 10.3390/cancers15143562