Last reviewed · How we verify
NCT04232852
Probiotics and Systemic Inflammation in Patients With Metabolic Syndrome and High Cardiovascular Risk
NA trial testing Probiotic mix in Metabolic Syndrome. Withdrawn.
26 January 2021
Quick facts
| Lead sponsor | Attikon Hospital |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Start date | 12 June 2019 |
| Primary completion | 26 January 2021 |
| Estimated completion | 26 January 2021 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- Probiotic mix
- Placebo
Conditions studied
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
- Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →
Sponsor
Attikon Hospital
Who can join
50 and older, any sex, with Metabolic Syndrome or Cardiovascular Risk Factor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Metabolic Syndrome (MetS) and cardiovascular disease are associated with systemic inflammation (SI). Activation of the mechanisms of inflammation is triggered by the inflammatory cytokines. Τhe NLRP3 inflammasome is activated by microbial-derived low molecular weight (LMW) factors, short chain fatty acids (SCFAs), pathogen-associated molecular pattern molecules (PAMPs), damage-associated molecular pattern molecules (DAMPs), and monosodium urate crystals. Probiotics can regulate inflammation in two ways: 1) indirectly, by producing SCFAs as well as increasing synthesis of antimicrobial peptides and 2) directly, by binding innate immune system receptors Toll-like (TLR 2, 4, 9) and triggering important signaling pathways associated with activation of NLRs affecting the formation of inflammasome, thus the inflammatory response.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
NLRP3 inflammasome: a key player in the pathogenesis of life-style disorders.
Ramachandran R, Manan A, Kim J, Choi S. · · 2024 · cited 67× · PMID 38945951 · DOI 10.1038/s12276-024-01261-8
Verify or expand the search:
- PubMed search for NCT04232852
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Attikon Hospital trials
Trials by the same sponsor.
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- NCT06810700 — The Association Between Time in Range With Markers of Endothelial and Cardiovascular Function · not yet recruiting
- NCT06978387 — The Association Between Glycemic Metrics and Cardiovascular Markers in Patients With Type 1 Diabetes. · active not recruiting
- NCT06749613 — Digestive Enzyme Formulation Intervention in IBS Patients Who Previously Clinically Responded to Mediterranean LFD · 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 NCT04232852 (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 Attikon Hospital
- Last refreshed: 7 April 2022
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/NCT04232852.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing