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Lactobacillus Rhamnosus in Prevention of Chemotherapy-related Diarrhoea

NCT00197873 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-11-24

No results posted yet for this study

Summary

Chemotherapy may cause diarrhoea, which may be associated with treatment delay and infections. The purpose of the study is to investigate whether oral supplementation with lactobacilli will alleviate chemotherapy related diarrhoea. Patients diagnosed with advanced colorectal cancer and who will receive chemotherapy will be randomly assigned to receive either lactobacilli or placebo during chemotherapy. The study is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The primary outcome measure is frequency of moderate/severe diarrhoea. The study will also address safety and tolerability of chemotherapy, response to chemotherapy, and serum growth factor levels.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactobacillus Rhamnosus supplementation

Lactophilus supplementation is administered during chemotherapy.

OTHER

Placebo administration.

Placebo is administered during chemotherapy.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Heikki Joensuu, M.D. · Department of Oncology, Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2020-11-30
Completion
2020-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00197873 on ClinicalTrials.gov