Last reviewed · How we verify
NCT03728868
Tolerability and Risk of Adverse Events With a Probiotic Supplement
NA trial testing Placebo in Healthy Individuals in 50 participants. Completed in 31 May 2019.
31 May 2019
Quick facts
| Lead sponsor | Sahlgrenska University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 50 |
| Start date | 10 October 2018 |
| Primary completion | 31 May 2019 |
| Estimated completion | 31 May 2019 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Placebo
- High dose F. prausnitzii and D. piger
- Low dose F. prausnitzii and D. piger
Conditions studied
- Healthy Individuals — all drugs for Healthy Individuals →
Sponsor
Sahlgrenska University Hospital
Who can join
Adults 20 to 40, any sex, with Healthy Individuals. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The butyrate-producing bacterium Faecalibacterium prausnitzii is abundant in the human bowel and can make up to 5% of the gastrointestinal flora in healthy individuals. A reduced presence of it has been associated with an imbalance in the gastrointestinal flora of metabolic syndromes such as type 2 diabetes, fat liver, and in inflammatory bowel disease. The present double-blind, placebo-controlled, randomized study is designed to investigate if dietary supplementation with F.prausnitzii (combined with D. piger) once a day for 8 consecutive weeks is tolerated compared to placebo and if it can affect the metabolism in a positive way.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Synergy and oxygen adaptation for development of next-generation probiotics.
Khan MT, Dwibedi C, Sundh D, Pradhan M, et al · · 2023 · cited 115× · PMID 37532933 · DOI 10.1038/s41586-023-06378-w
Verify or expand the search:
- PubMed search for NCT03728868
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03728868 (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 Sahlgrenska University Hospital
- Last refreshed: 25 February 2020
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/NCT03728868.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing