METHOD: The study is a randomized, double-blind, placebo-controlled trial. In total, 40 patients were recruited. Patients were randomized to receive either microbial cell preparation (n = 20) or placebo (n = 20) for 7 days prior to elective surgery. The primary end point was the time to return of normal gut function, while the secondary end point was the duration of hospital stay.
RESULTS: The treatment group demonstrated significantly faster return of normal gut function with a median of 108.5 h (80-250 h) which was 48 h earlier than the placebo group at a median of 156.5 h (94-220 h), p = 0.022. The duration of hospital stay in the treatment group was also shorter at a median of 6.5 days (4-30 days), in comparison to the placebo group at 13 days (5-25 days), p = 0.012.
CONCLUSION: Pre-surgical administration of microbial cell preparation promotes the return of normal gut function in patients after colorectal cancer surgery, thus associated with faster recovery and shorter duration of hospital stay.
METHODS: In this double-blind, randomized, placebo-controlled, single-center trial, 280 patients with PD were screened, and 72 eligible patients were block-randomized (1:1) to receive either multistrain probiotics capsules (n = 34) or identical-appearing placebo (n = 38), for 4 weeks. The primary endpoint was the change in the average number of spontaneous bowel movements (SBM) per week during the last 2 weeks of intervention compared with the 2-week preintervention phase, recorded by daily stool diary. Secondary outcome measures included changes in stool consistency, constipation severity score, and quality of life related to constipation. Satisfaction with intervention received was assessed. Change in levels of fecal calprotectin, a marker of intestinal inflammation, was an exploratory outcome.
RESULTS: SBM increased by 1.0 ± 1.2 per week after treatment with probiotics and decreased by 0.3 ± 1.0 per week in the placebo group (mean difference 1.3, 95% confidence interval 0.8-1.8, p < 0.001). Significant improvements were also seen for secondary outcomes after correction for multiple comparisons, including stool consistency (p = 0.009) and quality of life related to constipation (p = 0.001). In the treatment group, 65.6% reported satisfaction with the intervention vs only 21.6% in the placebo group (p < 0.001). One patient (2.9%) in the treatment group withdrew due to a nonserious adverse event. Fecal calprotectin did not change significantly during the study.
CONCLUSIONS: Multistrain probiotics treatment was effective for constipation in PD. Further studies are needed to investigate the long-term efficacy and safety of probiotics in PD, as well as their mechanisms of action.
CLINICALTRIALSGOV IDENTIFIER: NCT03377322.
CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that, for people with PD, multistrain probiotics significantly increased the average number of SBM per week.
PRACTICAL APPLICATION: The Lactobacillus strains tested in this study could be considered good potential probiotic candidates for food/feed industry because of their beneficial functional bioactivities such as good cholesterol-reducing ability, high antioxidant activity, and good and selective cytotoxic effect against cancer cells.