TS_NGP_SafetyA
Research type
Research Study
Full title
Next Generation Probiotics for Metabolic Health: A Double-blind, Randomized, Placebo-controlled Safety Trial, TS_NGP_SafetyA
IRAS ID
328119
Contact name
Pia Rasinkangas
Contact email
Sponsor organisation
Danisco Sweeteners Oy
Duration of Study in the UK
0 years, 5 months, 13 days
Research summary
Probiotics are defined as “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host”. Our gastrointestinal tract and the gut microbiota contain trillions of bacteria, which are important for functions such as digesting food and educating and activating the immune system. Next Generation Probiotics (NGPs) are a completely new class of probiotics based on bacterial strains that naturally live in the human body. A potential NGP strain Akkermansia massiliensis Am-200 will be clinically tested for the first time in healthy volunteers. Participants will be randomised to three groups (low dose AM-200, high dose AM-200, or placebo control) and treated for 4 weeks, with a wash-out follow up period of 4 weeks. Safety and tolerability tests will be carried out across 6 visits over the study period.
REC name
West of Scotland REC 3
REC reference
24/WS/0081
Date of REC Opinion
2 Jul 2024
REC opinion
Favourable Opinion