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NCT03728868

Tolerability and Risk of Adverse Events With a Probiotic Supplement

Completed NA Last updated 25 February 2020
What this trial tests

NA trial testing Placebo in Healthy Individuals in 50 participants. Completed in 31 May 2019.

Timeline
10 October 2018
Primary endpoint
31 May 2019
31 May 2019

Quick facts

Lead sponsorSahlgrenska University Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeother
Enrollment50
Start date10 October 2018
Primary completion31 May 2019
Estimated completion31 May 2019
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other recruiting trials for Healthy Individuals

Currently open trials in the same condition.

Other Sahlgrenska University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

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