Effect of Sporebiotics in FD

Status Completed

Clinical Trial Summary

Single-site prospective interventional study aiming to demonstrate the effect of spore-forming probiotics on dyspeptic symptoms and blood, saliva and stool parameters in FD patients with and without acid suppression, compared to placebo.

Clinical Trial Description

Prospective randomized placebo-controlled study in 2 parallel FD cohorts (8 weeks) with open-label extension phase (8 weeks): - cohort 1FD (on-PPI): study procedures at inclusion (1) and after 8 weeks on-PPI+ sporebiotics or placebo (2) followed by 8 weeks on-PPI+ sporebiotics (open label) - cohort 2FD (off-PPI): study procedures at inclusion (1) and after 8 weeks of sporebiotics or placebo (2) followed by 8 weeks of sporebiotics (open label) Clinical outcomes and blood, saliva and stool parameters will be assessed at the beginning and end of each treatment period (week 0, 8 and 16) with additional questionnaires after 1 month (week 4 and 12). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04030780
Study type	Interventional
Source	Universitaire Ziekenhuizen Leuven
Contact
Status	Completed
Phase	N/A
Start date	June 3, 2019
Completion date	December 31, 2020

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