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NCT04030780

Effect of Sporebiotics in FD

Completed NA Last updated 16 February 2021
What this trial tests

NA trial testing spore-forming probiotic in Dyspepsia in 60 participants. Completed in 31 December 2020.

Timeline
3 June 2019
Primary endpoint
7 July 2020
31 December 2020

Quick facts

Lead sponsorUniversitaire Ziekenhuizen KU Leuven
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment60
Start date3 June 2019
Primary completion7 July 2020
Estimated completion31 December 2020
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

Adults 18 to 99, any sex, with Dyspepsia or Dysbiosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy and safety of spore-forming probiotics in the treatment of functional dyspepsia: a pilot randomised, double-blind, placebo-controlled trial.
    Wauters L, Slaets H, De Paepe K, Ceulemans M, et al · · 2021 · cited 66× · PMID 34358486 · DOI 10.1016/s2468-1253(21)00226-0
  2. Recent advances in therapeutic probiotics: insights from human trials.
    Cho M-Y, Eom J-H, Choi E-M, Yang S-J, et al · · 2025 · cited 17× · PMID 40261032 · DOI 10.1128/cmr.00240-24

Verify or expand the search:

Other recruiting trials for Dyspepsia

Currently open trials in the same condition.

Other Universitaire Ziekenhuizen KU Leuven trials

Trials by the same sponsor.

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Data sources for this page

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