Effect of a probiotic mix on functional constipation in adult women: a randomized double-blind study

Abstract

Constipation is a common clinical condition in women, and the use of probiotics is indicated for the improvement of gastrointestinal functions. The objective of this study is to evaluate the effectiveness of a mix of 6 strains of probiotics (genera Lactobacillus and Bifidobacterium) in women with symptoms of constipation. A randomized, double-blind, placebo-controlled clinical trial was conducted with 84 women diagnosed with constipation (ROMA III criteria) who were followed for 6 weeks. 1-2x109 CFU of probiotics (intervention group) and 3-6g of maltodextrin (placebo group) were used. For comparison between groups, Pearson’s chi-squared and Student’s t tests (p≤0.05) were applied. In the intervention group, 38 women completed the study versus 31 in the placebo group. In the ROMA III criteria grouping, the placebo group showed an improvement in the 3rd and 4th weeks (p=0.033) when given two daily doses of the products. The number of bowel movements increased from ≤ 3 - at baseline in both the intervention and control groups - to an average of 4.42±1.7 and 4.87±3.2 at week six, respectively, with no differences between weeks (p>0.05). There was an improvement in gastrointestinal symptoms and stool consistency over the period, the latter being significant at the 5th intervention week (p=0.039). It was concluded that despite the improvement in the number of bowel movements, stool consistency, gastrointestinal symptoms and the ROMA III criteria grouping, there were the group using probiotics was not superior to the placebo.