NCT03341403 is a Phase 2, PHASE3 clinical trial of Probiotical®/Bactecal® in Asthma, sponsored by University of Liege.

Who is sponsoring NCT03341403?

NCT03341403 is sponsored by University of Liege.

What drugs are being tested in NCT03341403?

Interventions in NCT03341403: Probiotical®/Bactecal®, Placebo.

Is NCT03341403 still recruiting?

NCT03341403 is currently completed. Last updated 24 January 2024.

Last reviewed 2024-01-24 · How we verify

NCT03341403

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of a Synbiotic "Probiotical®/Bactecal® " in Asthma

Completed Phase 2, PHASE3 Last updated 24 January 2024

What this trial tests

Phase 2, PHASE3 trial testing Probiotical®/Bactecal® in Asthma in 55 participants. Completed in 30 September 2020.

Timeline

17 January 2017

Primary endpoint
30 September 2020

30 September 2020

Quick facts

Lead sponsor	University of Liege
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	treatment
Enrollment	55
Start date	17 January 2017
Primary completion	30 September 2020
Estimated completion	30 September 2020
Sites	1 location across Belgium

Drugs / interventions tested

Probiotical®/Bactecal®
Placebo

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

University of Liege

Who can join

Adults 18 to 75, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is a randomized double blind placebo control study. One hundred severe asthmatic patients will receive "Probiotical ®/Bactecal®" each day during 3 months and will be evaluated before and 1-3-6 months after in order to assess the impact of the synbiotic on the lung function, the exhaled nitric oxide value, the inflammatory blood and sputum profiles, the bronchial reactivity, the microvascular health and the quality of life and asthma control. The hypothesis is that, as these patients are not optimally controlled, the synbiotic could have an impact by decreasing the inflammation state at local and systemic level and then improve the quality of life and the asthma control. Indeed, synbiotic have been shown to possess beneficial effects on the immune system.

Publications & conference data

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

Investigational Treatments in Phase I and II Clinical Trials: A Systematic Review in Asthma.
Calzetta L, Aiello M, Frizzelli A, Pistocchini E, et al · · 2022 · cited 7× · PMID 36140430 · DOI 10.3390/biomedicines10092330
Synbiotic Bactecal® reduces airway obstruction, sputum eosinophils and IL-4 but increases sputum IL-8 in patients with uncontrolled asthma.
Moermans C, Graff S, Medard L, Nekoee H, et al · · 2026 · PMID 41936275 · DOI 10.1016/j.cyto.2026.157145

Verify or expand the search:

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Other University of Liege trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03341403 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Liege
Last refreshed: 24 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03341403.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing