Using synbiotics to prevent mucositis in colorectal cancer patients undergoing chemotherapy
Official title: Effect of Synbiotic Supplementation on the Prevention of Mucositis in Cancer Patients Undergoing Chemotherapy: Randomized, Double-masked, Parallel, Single-center Clinical Trial
Run by Federal University of Minas Gerais · NCT06576986 · Data updated 2026-11-12
This study is testing if taking synbiotics can help prevent mouth sores and diarrhea in people with colorectal cancer who are starting chemotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Federal University of Minas Gerais Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Belo Horizonte, Minas Gerais) |
| Status | Recruiting |
| Started | December 12, 2023 |
| Main results expected | December 12, 2025 |
| Study ends | December 12, 2026 |
| Registry record updated | August 29, 2024 |
| Trial ID | NCT06576986 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with a colorectal tumor in their first oncological treatment, eligible for capecitabine chemotherapy, and residing in Belo Horizonte or its metropolitan area.
✕Probably not a fit
Patients with certain gastrointestinal conditions, such as inflammatory bowel diseases or those who have had recent antibiotic use, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effect of synbiotic supplementation on preventing mucositis and diarrhea in patients with colorectal cancer receiving chemotherapy. It aims to determine whether administering synbiotics before chemotherapy can mitigate gastrointestinal damage caused by treatment, which often leads to severe complications. The study will include patients who are newly diagnosed with colorectal cancer and are eligible for chemotherapy with capecitabine. Participants will be monitored for symptoms of mucositis and diarrhea throughout their treatment regimen.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and treatment outcomes for colorectal cancer patients undergoing chemotherapy.
How similar studies have gone: Previous studies have suggested that probiotics may help prevent diarrhea in cancer patients, but the safety and efficacy of synbiotics in this context remain to be fully established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Colorectal tumor in the first oncological treatment * Age over 18 years old * Both sexes * Eligible for protocol with capecitabine alone or associated with oxaliplatin * Patients WITHOUT colostomy or WITH colostomy in the transverse/descending/sigmoid region * Patient undergoing Radiotherapy treatment associated with Chemotherapy * Patients residing in Belo Horizonte and the metropolitan region * Patients who Accept and sign the Informed Consent Form (TCLE) Exclusion Criteria: * Diagnosis of gastrointestinal carcinoid and stromal tumor (GIST) * Patients with Ileostomy * Patients with colostomy in the ascending region of the colon * Inflammatory bowel diseases: Crohn's and Colitis * Use of antibiotics and antifungals in the last 15 days * Use of prebiotic/probiotic and/or synbiotic in the last 15 days * Use of antidiarrheal medication in the last 15 days * Presence of fever and mucus discharge * Pregnant or breastfeeding women * Patients who refuse to participate in the study.
Where it's running
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Escola de Enfermagem - UFMG
Belo Horizonte, Minas Gerais, Brazil Recruiting
Study contacts
- Principal investigator: Simone de Vasconcelos Generoso — Escola de Enfermagem - UFMG
- Study coordinator: Simone de Vasconcelos Generoso
- Email: simonenutufmg@gmail.com
- Phone: 988128650
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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.