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. 

DOI Link

Study Purpose

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.