Plain language summary
Constipation is one of the commonest non-motor symptoms in Parkinson’s disease (PD). Recently, gut dysbiosis with alterations in faecal microbial composition was associated with the pathogenesis of PD and constipation. The aim of this study was to analyse the efficacy of a multi-strain probiotic combined with a prebiotic fibre (fructo-oligosaccharide) compared to placebo, on constipation symptoms and intestinal motility, in PD patients with constipation. This study is an eight-week investigator-initiated, double-blind, randomised, placebo-controlled single centre clinical trial involving 55 idiopathic PD patients. Patients were randomly assigned to one of the two treatment groups. Results showed that: - the consumption of a multi-strain probiotic (Hexbio) over 8 weeks, significantly improved bowel opening frequency and gut transit time in PD patients with constipation. - PD patients who consumed probiotics experienced a significantly higher mean weekly bowel movement compared to the placebo group. - patients who received probiotics reported increased weekly bowel opening frequency. - the percentage of patients who remained constipated was also significantly lower in the probiotic group (22.7%) compared to 57.7% in the placebo group. Authors conclude that Hexbio containing MCP BCMC strains was safe and effective in improving bowel opening frequency and gastrointestinal motility in PD patients with constipation.
Abstract
OBJECTIVE We determined the effectiveness of a multi-strain probiotic (Hexbio®) containing microbial cell preparation MCP®BCMC® on constipation symptoms and gut motility in PD patients with constipation. METHODS PD patients with constipation (ROME III criteria) were randomized to receive a multi-strain probiotic (Lactobacillus sp and Bifidobacterium sp at 30 X 109 CFU) with fructo-oligosaccaride or placebo (fermented milk) twice daily for 8 weeks. Primary outcomes were changes in the presence of constipation symptoms using 9 items of Garrigues Questionnaire (GQ), which included an item on bowel opening frequency. Secondary outcomes were gut transit time (GTT), quality of life (PDQ39-SI), motor (MDS-UPDRS) and non-motor symptoms (NMSS). RESULTS Of 55 recruited, 48 patients completed the study: 22 received probiotic and 26 received placebo. At 8 weeks, there was a significantly higher mean weekly BOF in the probiotic group compared to placebo [SD 4.18 (1.44) vs SD 2.81(1.06); (mean difference 1.37, 95% CI 0.68, 2.07, uncorrected p<0.001)]. Patients in the probiotic group reported five times higher odds (odds ratio = 5.48, 95% CI 1.57, 19.12, uncorrected p = 0.008) for having higher BOF (< 3 to 3-5 to >5 times/week) compared to the placebo group. The GTT in the probiotic group [77.32 (SD55.35) hours] reduced significantly compared to placebo [113.54 (SD 61.54) hours]; mean difference -36.22, 95% CI -68.90, -3.54, uncorrected p = 0.030). The mean change in GTT was 58.04 (SD59.04) hour vs 20.73 (SD60.48) hours respectively (mean difference 37.32, 95% CI 4.00, 70.63, uncorrected p = 0.028). No between-groups differences were observed in the NMSS, PDQ39-SI, MDS-UPDRS II and MDS-UPDRS III scores. Four patients in the probiotics group experienced mild reversible side effects. CONCLUSION This study showed that consumption of a multi-strain probiotic (Hexbio®) over 8 weeks improved bowel opening frequency and whole gut transit time in PD patients with constipation.
Methodological quality
Jadad score
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5
Allocation concealment
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Yes
