Evidence map›Paper›PMID 37046334›Full record

ArticleTrials2023

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.

Ya Chen, Xiaowei Liao, Yanmin Li, Hong Cao, Feng Zhang, Bojian Fei, Chuanqing Bao, Huaxiang Cao, Yong Mao, Xiaoping Chen and 3 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% of its field
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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
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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

13 authors at 1 institution in 1 country.

Ya Chen *Department of Endocrinology, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China.
Xiaowei Liao *State Key Laboratory of Food Science and Technology, School of Food Science and Technology, Jiangnan University, Wuxi, 214122, China.
Yanmin LiState Key Laboratory of Food Science and Technology, School of Food Science and Technology, Jiangnan University, Wuxi, 214122, China.
Hong CaoDepartment of Nutrition, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China.
Feng ZhangDepartment of Nutrition, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China.
Bojian FeiDepartment of Gastrointestinal Surgery, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China.
Chuanqing BaoDepartment of Gastrointestinal Surgery, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China.
Huaxiang CaoDepartment of Gastrointestinal Surgery, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China.
Yong MaoDepartment of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China.
Xiaoping ChenDepartment of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China.
Xiang GaoDepartment of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China.
Wei ZhaoState Key Laboratory of Food Science and Technology, School of Food Science and Technology, Jiangnan University, Wuxi, 214122, China. zhaow@jiangnan.edu.cn.ORCID http://orcid.org/0000-0001-9495-8508
Jianmin XuDepartment of Gastrointestinal Surgery, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China. 592220975@qq.com.
Jiangnan University · CN

Funding

Wuxi Project of Science and Technology Development N20191001Wuxi Project of Science and Technology Development N20192024)Wuxi Translational Medicine Research Special Funding Project ZZ003
6 · The paper itself

Abstract

backgroundThe 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.

methodsThis 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 registrationChinese Clinical Trial Registry ( www.chictr.org.cn ): ChiCTR2100046237. Registered on 12 May 2021.

Indexed as

Colorectal NeoplasmsDrug-Related Side Effects and Adverse ReactionsGastrointestinal MicrobiomeBiological AvailabilityGlucuronatesHumansOligosaccharidesPrebioticsQuality of LifeRandomized Controlled Trials as TopicGlucuronatesOligosaccharidesPrebioticsxylooligosaccharideAdverse effectsColorectal cancerDrug bioavailabilityGut microbiotaPrebioticPrimary tumor locations

Identifiers

PMID37046334
PMCPMC10091326
OpenAlexW4365145390

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.