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
ISRCTN Number
ISRCTN14398766
Duration of Study in the UK
0 years, 5 months, 13 days
Research summary
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.Summary of Results
This study is called “Next Generation Probiotics for Metabolic Health: a double blind, randomised, placebo-controlled safety trial.” The study was sponsored by Danisco Sweeteners Oy (IFF). It was run by clinical researchers, with support from a contract research organisation (FGK Clinical Research GmbH). The study was carried out at two centres in the United Kingdom between February 2025 and October 2025. The strain Akkermansia massiliensis had not been tested in humans before, so this study asked whether the product is safe to use, well tolerated, and whether it affects gut function or safety related laboratory markers. A total of 59 healthy adults aged 25–65 years took part. Participants took a daily capsule for 4 weeks. This contained either the probiotic at different doses or a placebo, followed by a 4 week follow up period. Participants were randomly assigned to groups and monitored regularly. Researchers collected data on symptoms, bowel habits, blood and urine tests, and stool samples. About half of participants reported mild side effects such as headache or digestive symptoms. There were no serious or severe adverse events, and no deaths occurred. Only two mild events (diarrhoea) were considered possibly related to the product. A. massiliensis was safe and well tolerated. It did not negatively affect gastrointestinal function or safety laboratory results. The study shows that this potential next generation probiotic can be safely given to humans, supporting further research into its potential health benefits, as further research is needed to study potential health benefits in larger and different populations.REC name
West of Scotland REC 3
REC reference
24/WS/0081
Date of REC Opinion
2 Jul 2024
REC opinion
Favourable Opinion