Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy
1 other identifier
observational
80
1 country
1
Brief Summary
To date, few studies have addressed the link between gut microbiota and breast cancer chemotherapy, and previous studies have only provided a link between the gut and breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2019
CompletedFirst Submitted
Initial submission to the registry
October 23, 2019
CompletedFirst Posted
Study publicly available on registry
October 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2020
CompletedOctober 25, 2019
September 1, 2019
1.1 years
October 23, 2019
October 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Transcriptional changes in gut microbiota
The microbiota measured by 16S rRNA gene
baseline,1 day,7 day,14 days,22 days,29 days,36 days,44days,51days,58days,66days,73days,80days
Study Arms (2)
Control group
20 healthy volunteers were included in the healthy control group
Disease group
First chemotherapy for breast cancer
Interventions
Eligibility Criteria
All patients were included according to the inclusion and exclusion criteria
You may qualify if:
- Aged 18 to 65 years
- First use of chemotherapy after breast cancer
You may not qualify if:
- Pregnancy
- Lactation
- Cigarette smoking
- Alcohol addiction
- Hypertension
- Diabetes mellitus
- Lipid dysregulation
- BMI \> 27
- Recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
- History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
- History of malignancy or any gastrointestinal tract surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001, China
Related Publications (2)
Luu TH, Michel C, Bard JM, Dravet F, Nazih H, Bobin-Dubigeon C. Intestinal Proportion of Blautia sp. is Associated with Clinical Stage and Histoprognostic Grade in Patients with Early-Stage Breast Cancer. Nutr Cancer. 2017 Feb-Mar;69(2):267-275. doi: 10.1080/01635581.2017.1263750. Epub 2017 Jan 17.
PMID: 28094541BACKGROUNDQin J, Li R, Raes J, Arumugam M, Burgdorf KS, Manichanh C, Nielsen T, Pons N, Levenez F, Yamada T, Mende DR, Li J, Xu J, Li S, Li D, Cao J, Wang B, Liang H, Zheng H, Xie Y, Tap J, Lepage P, Bertalan M, Batto JM, Hansen T, Le Paslier D, Linneberg A, Nielsen HB, Pelletier E, Renault P, Sicheritz-Ponten T, Turner K, Zhu H, Yu C, Li S, Jian M, Zhou Y, Li Y, Zhang X, Li S, Qin N, Yang H, Wang J, Brunak S, Dore J, Guarner F, Kristiansen K, Pedersen O, Parkhill J, Weissenbach J; MetaHIT Consortium; Bork P, Ehrlich SD, Wang J. A human gut microbial gene catalogue established by metagenomic sequencing. Nature. 2010 Mar 4;464(7285):59-65. doi: 10.1038/nature08821.
PMID: 20203603BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2019
First Posted
October 25, 2019
Study Start
September 12, 2019
Primary Completion
October 15, 2020
Study Completion
October 15, 2020
Last Updated
October 25, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share