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Trials
Published in: Trials 1/2023

Open Access 01-12-2023 | Respiratory Microbiota | Study protocol

Effects of prebiotic supplement on gut microbiota, drug bioavailability, and adverse effects in patients with colorectal cancer at different primary tumor locations receiving chemotherapy: study protocol for a randomized clinical trial

Authors: Ya Chen, Xiaowei Liao, Yanmin Li, Hong Cao, Feng Zhang, Bojian Fei, Chuanqing Bao, Huaxiang Cao, Yong Mao, Xiaoping Chen, Xiang Gao, Wei Zhao, Jianmin Xu

Published in: Trials | Issue 1/2023

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Abstract

Background

The prevalence of colorectal cancer (CRC) worldwide is a huge challenge to human health. Primary tumor locations found to impact prognosis and response to therapy. The important role of gut microbiota in the progression and treatment of CRC has led to many attempts of alleviating chemotherapy-induced adverse effects using microecologics. However, the underlying mechanism of the difference in the prognosis of different primary tumor locations and the synergistic effect of prebiotics on chemotherapy need to be further elucidated. This study aims to explore the differences in tumor microbiota and examine the effectiveness of xylooligosaccharides (XOS) on gut microbiota, adverse effects, and bioavailability of chemotherapy drugs in CRC patients at different primary tumor locations.

Methods

This is a double-blinded, randomized, parallel controlled clinical trial. Participants with left-sided CRC (LSCRC, n = 50) and right-sided CC (RSCC, n = 50) will randomly allocated to prebiotic group (n = 25) or control group (n = 25) and will receive either a daily XOS (3 g/day) or placebo, respectively, for 12 weeks. The primary outcomes will be the differences in the mucosa microbiota composition at different tumor locations and differences in gut microbiota composition, adverse effects, and blood concentration of capecitabine posttreatment. The secondary outcomes will include other blood indicators, short-chain fatty acids (SCFAs) concentration, quality of life, and mental health.

Discussion

This study will reveal the potential benefits of prebiotic for improving the gut microbiota composition, alleviating the adverse effects, and improving the efficacy of chemotherapy in patients with CRC. In addition, this study will provide data on the different distribution of tumor microbiota and the different changes of gut microbiota during treatment in LSCRC and RSCC, which may provide novel insights into personalized cancer treatment strategies based on primary tumor locations and gut microbiota in the future.

Trial registration

Chinese Clinical Trial Registry (www.​chictr.​org.​cn): ChiCTR2100046237. Registered on 12 May 2021.
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Metadata
Title
Effects of prebiotic supplement on gut microbiota, drug bioavailability, and adverse effects in patients with colorectal cancer at different primary tumor locations receiving chemotherapy: study protocol for a randomized clinical trial
Authors
Ya Chen
Xiaowei Liao
Yanmin Li
Hong Cao
Feng Zhang
Bojian Fei
Chuanqing Bao
Huaxiang Cao
Yong Mao
Xiaoping Chen
Xiang Gao
Wei Zhao
Jianmin Xu
Publication date
01-12-2023
Publisher
BioMed Central
Published in
Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07137-y

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