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Mego, M., Chovanec, J., Vochyanova-Andrezalova, I., Konkolovsky, P., Mikulova, M., Reckova, M., . . . Drgona, L. (2015). Prevention of irinotecan induced diarrhea by probiotics: A randomized double blind, placebo controlled pilot study. Complementary Therapies in Medicine, 23, 356–362.
To determine if the probiotic Colon Dophilus is able to prevent irinotecan-induced diarrhea in patients with metastatic colon cancer
Intervention Characteristics/Basic Study Process
Placebo versus probiotic Colon Dophilus. The probiotic was given three times per day for 12 weeks while the patient received irinotecan.
Sample Characteristics
N = 46
AGE = 42–81 years
MALES: 52.2%–60.9%, FEMALES 47.8%–39.1%
KEY DISEASE CHARACTERISTICS: Metastatic colon cancer
Setting
SITE: Multi-site
SETTING TYPE: Not specified
LOCATION: Slovenia
Phase of Care and Clinical Applications
PHASE OF CARE: Active antitumor treatment
Study Design
Placebo controlled stratified, double-blinded trial of study medication administered to patients with metastatic colon cancer starting therapy with an irinotecan-based chemotherapy regimen.
Measurement Instruments/Methods
Study diary
Common Terminology Criteria for Adverses Events (CTCAE)
Results
Probiotics reduced the incidence of grade 3 or 4 diarrhea compared with placebo (0% versus 17.4% for control group). Patients who used probiotics reported using fewer antidiarrheal medications.
Conclusions
Probiotics appear to be safe and may be of use in irinotecan-induced diarrhea.
Limitations
Small sample (less than 100)
Baseline sample/group differences of import
Measurement validity/reliability questionable
Early study termination due to poor accrual
Critical/fatal flaw–data on adherence/protocol compliance to probiotic consumption were not collected
Nursing Implications
More research on the use of probiotics and irinotecan-based chemotherapy is needed.