2767 - Final results of a phase II/III, randomized, double blind, placebo-controlled study to investigate the efficacy of a high potency multistrain probiotic, on chemotherapy induced diarrhea in cancer patients receiving fluropyrimidines and/or irinotecan based therapy

Background

Chemotherapy-induced diarrhea (CID) is a common side-effect, associated with weight-loss, malnutrition, and treatment breaks. Chemotherapy changes the composition of the native gut microflora. We hypothesized that a high-concentration multi-strain probiotic product might improve the balance of intestinal flora and thus reduce the incidence of severe diarrheal grades.

Methods

Randomized, double-blind, placebo-controlled single center study. Total sample size calculated was 242, however, protocol was amended to enrol 291 patients, accounting for loss to follow up or protocol deviations. Primary end-point was incidence of grade 3 and grade 4 diarrhea. Analysis of serum VEGF & clusterin and fecal calprotectin was also planned. Regulatory approvals and trial registration were done before study initiation.

Enrolled patients were randomized to receive 1 sachet bid of study drug (900 billion CFU/sachet of 4 strains of Lactobacillus, 3 strains of Bifidobacteria and 1 strain of Streptococcus thermophilus) or placebo (corn starch), starting 14 days before chemotherapy and continued till two weeks after end of chemotherapy cycle 3.

Results

Between July 2010 to November 2014, 291 patients were enrolled at AIIMS, New Delhi. Type and site of cancer (p=0.882) and chemotherapy regimen (p=0.492) were similar in both groups. Body weight between the two arms was found to be comparable at all study visits. Results are shown in Table-1.

Table -1

Conclusions

Results indicate a limited role of the probiotic in reducing incidence of severe CID. However, it was able to significantly reduce all grades of diarrheal episodes (taken together), levels of VEGF, fecal calprotectin and clusterin.

Clinical trial identification

Clinical Trial Registry India Identifier : CTRI/2009/091/001042

Editorial Acknowledgement

Not Applicable