Efficacy of freeze-dried Lactobacilli in functional diarrhoe: a pilot study

Background and objective: The pathogenic role of the intestinal milieu for symptoms in functional bowel disorders such as functional diarrhea (FD) or associated pain and bloating in the irritable bowel syndrome (IBS) is the rationale for probiotic treatment approaches. It was the aim of this pilot study to test the effects of a lyophilisate from devitalized lactobacilli and their culture medium in patients with chronic FD. Methods: Following a one-week basal period, 22 patients mit FD (12 with IBS) were treated with Lacteol (2 capsules/day) for 4 weeks. Stool frequency, consistency (assessed by BSFS), urge, pain and bloating were recorded daily using a standardized symptom diary, and global relief was recorded weekly. Results: Daily stool frequency and number of days with urge were significantly decreased starting in week 1 (-0.6 +/- 0.2/day; p = 0.005; and -1.3 +/- 0.3 days, respectively; p = 0.001). This effect persisted throughout week 4 (-0.6 +/- 0.2/day; p < 0.02; and -1.4 +/- 0.5 days, respectively; p = 0.025). After 4 weeks, 50% of patients reported satisfactory symptom relief, including improvement in maximal stool consistency (BSFS: -0.3 +/- 0.2; p = 0.04), and 43% of patients recorded a decrease in stool frequency of >= 25%. Conclusion: These findings suggest a clinically relevant efficacy of Lacteol in a subgroup of patients with FD, particularly with regard to stool frequency, urge and stool consistency. As the study design does not allow to exclude that a placebo component might have contributed to these effects, the results should be corroborated in an larger, placebo-controlled trial.