Randomised double blind placebo controlled trial on Lactobacillus reuteri DSM 17938: improvement in symptoms and bowel habit in functional constipation

Abstract

Dysbiosis may contribute to constipation and its symptoms, therefore probiotic administration could improve significantly gut health and functions. The aim of the study was to investigate the effects of a long-lasting administration of Lactobacillus reuteri DSM 17938 (LR DSM 17938) on symptoms and quality of life (QoL) score in patients with functional constipation (FC). 56 FC patients with normal colonic transit time and without anorectal disorders and pelvic floor dysfunctions completed the study. LR DSM 17938 was administered for 105 days in a randomised double-blind clinical trial (28 patients per arm). Individual and cumulative scores including the Constipaq, a modified Constipation Scoring System (CSS) that considers the patient assessment of constipation-QoL (PAC-QoL), were calculated during the preliminary visit (V0), at day 15 (end of the induction period with a LR DSM 17938 double dosage, 4×108 cfu), day 60 (intermediate evaluation) and day 105 (V4) after a standard dosage (2×108 cfu). At the end of treatment, the beneficial effect of LR DSM 17938 compared to placebo was significantly evident for symptoms related to gas content and dysbiosis (abdominal discomfort, pain and bloating), incomplete defecation and helps for defecation (P<0.05). At the end of the whole LR DSM 17938 treatment, a marked and positive effect on both the CSS single and the cumulative items was evident with the exception of unfruitful attempt and Bristol score. Present findings indicate that LR DSM 17938 has an effect on symptoms different from stool consistency, and they suggest that this probiotic can effectively be used in association therapy rather than as single-drug therapy in the management of FC.