Actively Recruiting
Observational Study of Gut Microbiota in Hormone Receptor-Positive Breast Cancer Patients Treated With Abemaciclib and Its Relation to Drug-Induced Diarrhea
Led by Hubei Cancer Hospital · Updated on 2026-04-03
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand why some patients with hormone receptor-positive breast cancer experience diarrhea when treated with Abemaciclib, a common medicine for this condition. The study focuses on the role of the natural bacteria in the gut, known as the gut microbiome, in causing this side effect. Researchers will compare the gut bacteria of patients who develop diarrhea with those who do not to learn more about this issue. The study is observational, meaning participants will continue their usual cancer treatment with Abemaciclib without receiving any new or experimental drugs. Participants will be grouped based on whether they experience diarrhea during treatment or not. The study involves collecting stool samples and optional blood samples at specific times to analyze gut bacteria types, functions, and biomarkers. Participants will provide samples and information during their treatment period, which lasts about six months on average. Researchers will assess differences in gut bacteria diversity, specific bacterial species, metabolic pathways, serum metabolites, and inflammatory markers. All personal data will be kept confidential and coded to protect privacy throughout the study.
CONDITIONS
Brief Title
Observational Study of Gut Microbiota in Abemaciclib-Treated Patients With and Without Diarrhea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- Diagnosed with hormone receptor-positive breast cancer
- Receiving Abemaciclib treatment for at least 2 weeks
- Willing and able to provide informed consent
You will not qualify if you...
- History of major gastrointestinal diseases such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, or intestinal obstruction
- Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine that may affect gut function
- Pregnant or lactating women
- Unwilling to provide informed consent or deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants are observed while receiving Abemaciclib treatment. Fecal and blood samples are collected for microbiome and biomarker analysis to study gut microbiota differences related to diarrhea occurrence.
Periodic sample collections during treatment
Trial Site Locations
Total: 1 location
1
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
Research Team
X
Xinhong Wu Principal Investigator
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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