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SPORE FORMING PROBIOTICS TRIAL

We randomly assigned 32 participants to probiotics and 36 to placebo. This study is registered with, NCT04030780.īetween June 3, 2019, and March 11, 2020, of 93 individuals assessed for eligibility, we included 68 patients with functional dyspepsia (51 women, mean age 40♱ years, 34 on proton-pump inhibitors). The primary endpoint was a decrease of at least 0♷ in the postprandial distress syndrome (PDS) score of the Leuven Postprandial Distress Scale in patients with a baseline PDS score of 1 or greater (at least mild symptoms), assessed in the intention-to-treat population. Symptoms, immune activation, and faecal microbiota were assessed and recorded.

All patients and on-site study personnel were masked to treatment allocation in the first 8 weeks. Individuals with a history of abdominal surgery, diabetes, coeliac or inflammatory bowel disease, active psychiatric conditions, and use of immunosuppressant drugs, antibiotics, or probiotics in the past 3 months were excluded.

SPORE FORMING PROBIOTICS TRIAL

In this single-centre, randomised, double-blind, placebo-controlled pilot trial that took place at University Hospitals Leuven (Leuven, Belgium), adult patients (≥18 years) with functional dyspepsia (as defined by Rome IV criteria, on proton-pump inhibitors or off proton-pump inhibitors) were randomly assigned (1:1) via computer-generated blocked lists, stratified by proton-pump inhibitor status, to receive 8 weeks of treatment with probiotics (Bacillus coagulans MY01 and Bacillus subtilis MY02, 2♵ × 10 9 colony-forming units per capsule) or placebo consumed twice per day, followed by an open-label extension phase of 8 weeks. We aimed to assess spore-forming probiotics in functional dyspepsia as monotherapy or add-on therapy to long-term treatment with proton-pump inhibitors. Electronic address: treatments for functional dyspepsia have limited efficacy or present safety issues.

10 Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.

Electronic address: 1 Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.

9 Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.

8 Department of Gastroenterology, Jessa Ziekenhuis, Hasselt, Belgium.

6 Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.

5 Experimental Vascular Pathology Group, Maastricht University Medical Centre, Maastricht, Netherlands.

4 Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.

3 Centre for Microbial Ecology and Technology, Ghent University, Ghent, Belgium.

2 Department of Immunology and Infection, Biomedical Research Institute, Hasselt University, Diepenbeek, Belgium.

1 Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.