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NCT03273296
Effect of Antibiotics on Gut Microbiome and Plasma Metabolome
Phase 4 trial testing Amoxicillin in Microbial Colonization in 39 participants. Completed in 15 December 2017.
15 December 2017
Quick facts
| Lead sponsor | Finnish Institute for Health and Welfare |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 39 |
| Start date | 15 October 2017 |
| Primary completion | 15 December 2017 |
| Estimated completion | 15 December 2017 |
| Sites | 1 location across Finland |
Drugs / interventions tested
- Amoxicillin (amoxicillin) — full drug profile →
- Azithromycin (azithromycin) — full drug profile →
- Vancomycin (vancomycin) — full drug profile →
Conditions studied
- Microbial Colonization — all drugs for Microbial Colonization →
Sponsor
Finnish Institute for Health and Welfare
Who can join
Adults 40 to 74, any sex, with Microbial Colonization. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In recent years it has been observed that the gut microbiome can produce metabolites into systemic circulation and thus have important health effects even outside the gastrointestinal system. These metabolites may play a role in the pathogenesis of common public health problems such as diabetes, obesity and cardiovascular disorders. Modern techniques of mass spectrometry-based metabolomics from peripheral blood and gut metagenome sequencing now enable detailed examination of these processes. Using samples from the FINRISK 2002 cohort, collected by the National Institute for Health and Welfare, we are currently determining the gut microbiome and plasma metabolome from \> 7000 participants with 15 years of follow-up for various health outcomes. This is one of the largest materials of its kind world-wide. The design does not, however, allow us to draw causal conclusions on the roles of gut bacteria in the composition of plasma metabolome. To enable conclusions which go beyond statistical associations, we now propose an extension to the FINRISK 2002 study, where we alter the gut bacteriome with a short course of antibiotics and then examine whether a change in plasma metabolomics profile will follow. At the same time the trial will give important novel information about the effects of commonly used antibiotics on gut bacteriome and on general health.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03273296
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Currently open trials in the same condition.
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Other Finnish Institute for Health and Welfare 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)
- Trial protocol + status: ClinicalTrials.gov NCT03273296 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Finnish Institute for Health and Welfare
- Last refreshed: 19 August 2025
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/NCT03273296.
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