Chitapanarux, I., Chitapanarux, T., Traisathit, P., Kudumpee, S., Tharavichitkul, E., & Lorvidhaya, V. (2010). Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients. Radiation Oncology, 5, 31.

To determine if the combination of Lactobacillus acidophilus plus Bifidobacterium bifidum is effective in preventing diarrhea in patients with locally advanced cervical cancer receiving radiation therapy

Patients were randomized to receive either L. acidophilus plus Bifidobacterium bifidum or placebo capsules. Beginning 7 days before and continuing throughout the entire time of receiving radiotherapy, participants took 2 capsules, 2 times each day before breakfast and dinner. Patients needing antidiarrheal medication were given loperamide (2 mg).

• The study reported on 63 patients.
• The median age was 52 years in the placebo group and 47 years in the study group.
• The sample was 100% female.
• All patients had International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IIIB squamous cell carcinoma of the cervix and were scheduled to receive standard treatment for locally advanced cervical cancer (i.e., external beam whole pelvis radiation and brachytherapy plus weekly cisplatin at 40 mg/m²).

The study was conducted in Thailand.

All patients were undergoing the active treatment phase of care.

This was a prospective, randomized, double-blind, placebo-controlled study.

The National Cancer Institute Common Toxicity Criteria, version 2, was used.

• All patients experienced diarrhea; however, the difference in the severity of the diarrhea was significant (p = 0.002). In the placebo group, 55% of patients experienced grade 1 diarrhea, 42% experienced grade 2, and 3% experienced grade 3. In the study group, 91% experienced grade 1 diarrhea, 9% experienced grade 2, and none experienced grade 3.
• The intervention group also had a significantly improved stool consistency (p < 0.001).  
• In the placebo group, 32% of patients needed antidiarrheal medication, compared with only 9% of patients in the study drug group (p = 0.03).

The prophylactic use of the combination of live L. acidophilus plus Bifidobacterium bifidum was shown to be effective in decreasing the severity of diarrhea.

• The sample size was small sample with fewer than 100 patients.
• Cultures were not performed on stool, which could have missed infectious causes of diarrhea. 
• The use of antimicrobials was not mentioned as exclusion criteria.

The prophylactic use of L. acidophilus plus Bifidobacterium bifidum may decrease the severity of diarrhea, improve stool consistency, and reduce the need for antidiarrheal medication in patients with locally advanced cervical cancer undergoing pelvic radiation with concomitant weekly cisplatin.  Further studies need to be done with larger samples.