Riezzo G, 2018
Italy
To study the effect of a 15-week supplementation of L. reuteri DSM 17938 in adults with chronic functional constipation and nor mal colonic transit time. Primary outcome was change in Constipaq score (constipation symptoms and quality of life). Secondary outcomes were constipation symptom item’s scores. Mean age 44 years.
R, DB, PC 105 days
L. reuteri: 28 (Induc tion period, 15 days: 4×108 CFU=4 tablets Standard dose, 90 days: 2×108 CFU=2 tablets) Placebo: 28
Compared to the placebo group at day 105, L. reuteri signifi cantly: • Reduced the Constipaq score, which includes quality-of-life evaluation (p<0.0001)
• Reduced symptoms related to gas production and dysbiosis (incomplete defecation, abdominal discomfort, pain, and bloating)
• Reduced the need of laxatives L. reuteri had no effect on stool consistency.
Riezzo G, 2019
(substudy of Riezzo 2018) Italy
To evaluate pathophysiological aspects = serum concentrations of GI neuropeptides serotonin (5-HT) and brain-derived neurotrophic factor (BDNF) and their associa tion with changes in symptoms and quality-of-life scores during intake of L. reuteri DSM 17938 or placebo in adults with chronic functional constipation (FC). Results on symp toms and quality of life (QoL) in this cohort of patients are previously published in Riezzo et al. 2018.
R, DB, PC 105 days
See information above. Additional group of healthy controls, n= 20, for comparison of serum levels of 5-HT and BDNF
• Baseline serum levels of 5-HT were significantly higher in FC subjects compared to healthy controls
• 5-HT and BDNF were significantly reduced compared to pla cebo at the end of intervention (day 105)
• 5-HT in the Lr group was reduced by 24% (p<0.008) to a level non-significant from that of healthy controls, and significant ly different from placebo (p<0.04), on day 105. • Neither 5-HT nor BDNF serum levels showed correlation with the symptoms or QoL scores.
Ojetti V, 2014
Italy
The effect of L. reuteri DSM 17938 on functional constipation in adults of mean age 35.6 (± 15) years
R, DB, PC 4 weeks
L. reuteri: 20 (2×108 CFU) Placebo: 20
• Frequency of defecation per week was significantly increased at week 4 compared to placebo
• Stool consistency was somewhat improved but without significant difference compared to baseline or compared to placebo
Ojetti V, 2017
Italy
The effect of L. reuteri DSM 17938 on production of methane (CH4 ) in adults with functional constipa tion. Methane production of >5 ppm during a H2 /CH4 lactulose breath test (LBT). Mean age 36y.
Open, no control group 4 weeks
L. reuteri: 20 (2×108 CFU)
• Compared to baseline, there was a significant reduction in the CH4 production by L. reuteri: 8.9 ± 8.6 ppm vs. 20.8 ± 15 ppm, and on AUC value (Area Under the Curve): 2128.4 vs. 5101.5.
• 11 patients (55%) ceased to produce methane (<5 ppm).
• Bowel movements/week were significantly increasedcompa red to baseline: 6.4 ± 0.7 vs. 4.1 ± 1.2.