Dataset Information

Efficacy and Safety of New Lactobacilli Probiotics for Unconstipated Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

ABSTRACT: Irritable bowel syndrome (IBS) is a common and chronic gastrointestinal disorder. Probiotics may have the potential to impact the management of IBS; however, the results of trials are conflicting. This study aimed to investigate whether a mixture of lactobacilli probiotics could improve abdominal symptoms in patients with unconstipated IBS. Fifty Vietnamese patients with unconstipated IBS were randomly assigned to either the probiotics or placebo groups. During the intervention, participants took the probiotic supplement, named Foodis Lactobacillus, or placebo capsule once a day. Patients recorded their subject global assessment (SGA) weekly and were assessed with the visual analogue scale (VAS) during the 4-week study period. Patients with SGA score of 2 points or more or a decrease of more than 30% in VAS score were considered responders. Patients who responded weekly for more than 2 of the 4 weeks were considered overall responders. There was no significant difference in demographic characteristics between the groups. Overall responder rates of improvement of global IBS symptoms assessed by SGA score were significantly higher in the probiotics group (80.8%) than in the placebo group (45.8%) (p = 0.009). The overall responder rates assessed by VAS score were also higher in the probiotics group (69.2%, 41.7%, p = 0.048). There were no adverse events in either group during the study period. Our findings suggest that the new combination of Lactobacilli appears to be promising in the relief of abdominal symptoms in Vietnamese patients with unconstipated IBS.

SUBMITTER: Oh JH

PROVIDER: S-EPMC6950464 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy and Safety of New <i>Lactobacilli</i> Probiotics for Unconstipated Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

Oh Joo Hyun JH Jang Yeon Sil YS Kang Danbee D Chang Dong Kyung DK Min Yang Won YW

Nutrients 20191127 12

Irritable bowel syndrome (IBS) is a common and chronic gastrointestinal disorder. Probiotics may have the potential to impact the management of IBS; however, the results of trials are conflicting. This study aimed to investigate whether a mixture of <i>lactobacilli</i> probiotics could improve abdominal symptoms in patients with unconstipated IBS. Fifty Vietnamese patients with unconstipated IBS were randomly assigned to either the probiotics or placebo groups. During the intervention, participa ...[more]

PMID: 31783597

Similar Datasets

Project description:ObjectivesCurrent irritable bowel syndrome (IBS) treatments have limited efficacy and probiotics like Bacillus clausii (B. clausii) were found to be effective in the management of several gastrointestinal disorders. This phase III trial assessed the efficacy and safety of adding B. clausii (four strains: O/C, N/R, SIN, T), versus placebo, to conventional treatment of pediatric IBS in Mexico.MethodsPatients aged 6-17 years 11 months with IBS (Rome IV) for at least 2 months were randomized to receive either B. clausii (oral suspension, total dose 4 billion spores/day) or placebo once daily for 8 weeks. All patients also received conventional treatment. The primary endpoint was the difference in the proportion of patients with clinical improvements at Week 8 (Global Assessment Questions [GAQ]). Secondary endpoints included responders by Subject's Global Assessment of Relief for Children with IBS (SGARC); number/consistency of stools; abdominal distention/bloating; abdominal pain/intensity; and IBS behavior.Results73.6% (95% confidence interval [CI] 67.3-80.0; B. clausii n = 129) and 78.5% (95% CI 72.5-84.4; placebo n = 130) of patients had symptom improvement (p = 0.8182). For Week 8 SGARC, 19.2% (B. clausii) and 20.9% (placebo) reported complete symptom relief. Stool evaluations, bloating, abdominal pain/intensity, and IBS behavior were similar between groups. Both treatments were well tolerated.ConclusionNo significant differences in efficacy between B. clausii and placebo were demonstrated in addition to conventional treatment. The sample size calculation was based on an expected placebo/conventional treatment response of 30-40%. However, the actual treatment response observed was 80% and, thus, a study with larger population would be warranted. In addition, this study was conducted during the COVID-19 pandemic, when such controlled social conditions may have resulted in better diet, greater family stability, less psychological stress, and lower risk of infections exacerbating IBS, thereby improving symptoms in both groups.Eudract number2018-004519-31.

Project description:AimTo examine the efficacy and safety of otilonium bromide (OB) in treatment-sensitive functional irritable bowel syndrome (IBS) clinical parameters.MethodsNinety-three patients (44.8 ± 12.6 years, 69% female) with IBS symptoms complying with Rome II criteria participated in this double-blind, placebo-controlled, randomised, dose-ranging phase I/II study. Patients were administered OB 20 mg (n = 24), 40 mg (n = 23) and 80 mg (n = 23) tid or placebo (n = 23) in 4 parallel groups for 4 wk. Primary efficacy variables included abdominal discomfort, intestinal habits, number of daily evacuations and stool consistency. Secondary efficacy measures included return to regular intestinal habits and global discomfort. Safety was also assessed.ResultsBaseline clinical characteristics were similar among the 4 groups. Although individual parameters such as intensity and frequency of abdominal discomfort, bloating or pain were reduced by OB over the 4 wk, no significant differences were observed between groups. Similarly, no difference was observed between OB treatment or placebo for mucus in stool and incomplete or difficulty of evacuation. However, evacuation frequency was significantly reduced after 4 wk by 80 mg OB compared to placebo (-8.36% for placebo vs -41.9% for 80 mg OB, P < 0.01). While 21.7% of patients in the placebo group experienced regular intestinal habits after 4 wk, this improvement was greater for patients treated with 40 mg OB (P < 0.01 vs placebo). Furthermore, a dose-dependent reduction in frequency of diarrhoea (χ(2)-test for trend = 11.5, P < 0.001) and an increase in normal stool frequency was observed. Combining individual variables into a global discomfort index revealed significant improvement among increasing OB doses, favouring 40 mg (P = 0.013) and 80 mg OB (P = 0.001) over placebo. No difference was observed between frequency of adverse events for placebo vs OB.ConclusionThis dose-ranging study demonstrates that OB at 40 and 80 mg can improve individual and global clinical symptoms of IBS compared to placebo over a 4-wk period.

Dataset Information

Efficacy and Safety of New Lactobacilli Probiotics for Unconstipated Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

Publications

Efficacy and Safety of New <i>Lactobacilli</i> Probiotics for Unconstipated Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets