Last reviewed · How we verify
NCT03408691: ProSPer
PRObiotic and Stress-related PERmeability
NA trial testing Fresh fermented dairy drink containing probiotic strain in Permeability; Increased in 117 participants. Completed in 31 March 2019.
22 March 2019
Quick facts
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 117 |
| Start date | 23 January 2018 |
| Primary completion | 22 March 2019 |
| Estimated completion | 31 March 2019 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Fresh fermented dairy drink containing probiotic strain
- Acidified dairy drink without ferment
Conditions studied
- Permeability; Increased — all drugs for Permeability; Increased →
Sponsor
Universitaire Ziekenhuizen KU Leuven — full company profile →
Who can join
Adults 20 to 30, any sex, with Permeability; Increased. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-site exploratory study aiming to demonstrate the effect of a fresh fermented dairy drink containing a probiotic strain on stress-related intestinal hyperpermeability in students defending a bachelor's or master's thesis in front of a jury at the University of Leuven (Belgium).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
<i>Lactobacillus rhamnosus</i> CNCM I-3690 decreases subjective academic stress in healthy adults: a randomized placebo-controlled trial.
Wauters L, Van Oudenhove L, Accarie A, Geboers K, et al · · 2022 · cited 25× · PMID 35130109 · DOI 10.1080/19490976.2022.2031695 -
Does the Gut Microbial Metabolome Really Matter? The Connection between GUT Metabolome and Neurological Disorders.
Marć MA, Jastrząb R, Mytych J. · · 2022 · cited 18× · PMID 36235622 · DOI 10.3390/nu14193967 -
Probiotic-mediated modulation of gut microbiome in students exposed to academic stress: a randomized controlled trial.
Vázquez-Castellanos JF, Maciel LF, Wauters L, Gregory A, et al · · 2025 · PMID 40691449 · DOI 10.1038/s41522-025-00776-w
Verify or expand the search:
- PubMed search for NCT03408691
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Permeability; Increased
Currently open trials in the same condition.
- NCT05477212 — Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet. · NA · recruiting
- NCT04565821 — Feasibility Study to Assess a Trans-nasal Intestinal Potential Difference Probe · NA · active not recruiting
Other Universitaire Ziekenhuizen KU Leuven trials
Trials by the same sponsor.
- NCT06831955 — LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer · Phase 2 · recruiting
- NCT07356505 — Efficacy and Safety of Micra AV2 Transcatheter Pacing System · NA · recruiting
- NCT07286968 — Gastro-Intestinal Digestion and Physiology After Bariatric Surgery · recruiting
- NCT06962137 — Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer · Phase 2 · recruiting
- NCT07270536 — Accelerated Pacing and Cardiac Filling Pressures During Exercise in Patients With Heart Failure With Preserved Ejection · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03408691 (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 Universitaire Ziekenhuizen KU Leuven
- Last refreshed: 4 June 2019
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/NCT03408691.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing