Investigating how gut bacteria affect diarrhea from cancer treatment
Official title: Role of the Gut Microbiome in Anti-tumor Therapy Induced Diarrhea
Run by Medical University of Graz · NCT05873231 · Data updated 2026-11-12
This study is trying to see how the bacteria in the gut affect diarrhea in patients with liver cancer who are being treated with specific cancer drugs.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Drugs / interventions | lenvatinib |
| Locations | 1 site (Graz) |
| Status | Recruiting |
| Started | April 28, 2021 |
| Main results expected | December 2030 |
| Study ends | December 2032 |
| Registry record updated | November 25, 2025 |
| Trial ID | NCT05873231 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are starting systemic anti-cancer therapy for hepatocellular carcinoma.
✕Probably not a fit
Patients with pre-existing diarrhea or those who have received antibiotics or probiotics shortly before the study may not benefit from this research.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study examines the role of the gut microbiome in the development of diarrhea as a side effect of anti-cancer therapies, specifically focusing on patients with hepatocellular carcinoma (HCC) undergoing treatment with tyrosine kinase inhibitors (TKIs). By assessing the gut microbiome composition in patients starting systemic anti-cancer therapy, the study aims to identify potential mechanisms behind TKI-induced diarrhea. The research will involve a longitudinal cohort of patients, tracking their microbiome changes and correlating them with the incidence of diarrhea during treatment. This could lead to a better understanding of how to manage side effects and improve treatment efficacy.
Why it matters
Potential benefit: If successful, this study could lead to improved management of diarrhea in cancer patients, enhancing their treatment experience and outcomes.
How similar studies have gone: While there is emerging data on the impact of the gut microbiome on cancer treatment side effects, this specific approach is relatively novel and has not been extensively tested in larger cohorts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Start of a systemic anti-cancer therapy * Informed consent Exclusion Criteria: * • Pre-existing diarrhoea * Antibiotic therapy -4 to -1 week before inclusion * Probiotic treatment -4 to -1 week before inclusion * Inability to give informed consent
Where it's running
-
Department of Internal Medicine, Medical University of Graz
Graz, Austria Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.