NCT03782428

An Evaluation of Probiotic in the Clinical Course of Patients With Colorectal Cancer

Completed NA Last updated 20 December 2018

What this trial tests

NA trial testing Probiotic in Colorectal Cancer in 52 participants. Completed in 26 November 2018.

Timeline

26 August 2016

Primary endpoint
16 November 2018

26 November 2018

Quick facts

Lead sponsor	Dr. Liyana Zaharuddin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	52
Start date	26 August 2016
Primary completion	16 November 2018
Estimated completion	26 November 2018

Drugs / interventions tested

• Probiotic
• Placebo

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Dr. Liyana Zaharuddin

Who can join

18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Colorectal cancer (CRC) is the most common cancer for men and the second most common for women. Several studies have shown that gut microbiome may play a role in triggering intestinal inflammation that leads to the development of CRC. Gut microbiome is the collection of microorganisms that inhabit the gut. Therefore, manipulation of the gut microbiome via administration of probiotics may potentially improve the health and nutritional status in patients with CRC. The aims of this study are to investigate the role of probiotic functional foods in reducing CRC-related inflammatory markers and symptom alleviation.Participants will be needed to complete an information details form which includes information on age, medical history, background details and diet. Participants are required to consume the investigational product twice daily for six months. Blood samples will be collected prior to surgery and at 6th months post product consumption. These blood samples will be processed and analysed.

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. A randomized double-blind placebo-controlled trial of probiotics in post-surgical colorectal cancer.
   Zaharuddin L, Mokhtar NM, Muhammad Nawawi KN, Raja Ali RA. · · 2019 · cited 184× · PMID 31340751 · DOI 10.1186/s12876-019-1047-4
3. Gut microbiome in modulating immune checkpoint inhibitors.
   Li X, Zhang S, Guo G, Han J, et al · · 2022 · cited 113× · PMID 35841869 · DOI 10.1016/j.ebiom.2022.104163
4. 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
5. Potential effects of gut microbiota on host cancers: focus on immunity, DNA damage, cellular pathways, and anticancer therapy.
   Sun J, Chen F, Wu G, Wu G. · · 2023 · cited 71× · PMID 37553473 · DOI 10.1038/s41396-023-01483-0
6. Probiotics and postbiotics in colorectal cancer: Prevention and complementary therapy.
   Kvakova M, Kamlarova A, Stofilova J, Benetinova V, et al · · 2022 · cited 48× · PMID 36158273 · DOI 10.3748/wjg.v28.i27.3370
7. Gut Microbiota Manipulation as a Tool for Colorectal Cancer Management: Recent Advances in Its Use for Therapeutic Purposes.
   Perillo F, Amoroso C, Strati F, Giuffrè MR, et al · · 2020 · cited 43× · PMID 32751239 · DOI 10.3390/ijms21155389
8. Gut microbiome homeostasis and the future of probiotics in cancer immunotherapy.
   Singh A, Alexander SG, Martin S. · · 2023 · cited 35× · PMID 37261348 · DOI 10.3389/fimmu.2023.1114499