PE_ChillEx (Mind Balancing Microbes)
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, parallel-groups clinical trial to assess the safety and efficacy of Lactobacillus paracasei (Lpc-37) to modulate psychological stress.
IRAS ID
258942
Contact name
Balgit Chhokar
Contact email
Sponsor organisation
DuPont
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
This clinical study is trying to see if the investigational product, Lpc-37, can help to control psychological stress.
According to the World Health Organisation, between 1990 and 2013, the number of people suffering from depression and/or anxiety increased by nearly 50%, from 416 million to 615 million. Therefore, it would be of vast benefit to society if non-medicinal products were available which are capable of controlling anxiety and improving mood and coping behaviour during stressful life events.
The investigational product in this study is a dietary supplement known as Lpc-37. Lpc-37 is a probiotic strain from the species Lactobacillus paracasei. Probiotics are defined as 'live microorganisms, that, when consumed in adequate amounts, provide a health benefit'. Probiotics have long been associated with health benefits particularly related to gastrointestinal and immune function, however recent evidence suggests that probiotics may impact on brain physiology, function and behaviours and therefore may also be able to help alleviate symptoms of stress.
The study would involve approximately 190 participants at 7 research sites, in 2 countries - the United Kingdom and Ireland.
Participants aged between 18-40 years old will be recruited from the population of local medical, dental and health science students who are in preparation for university semester examinations. This population is stress vulnerable/sensitive due to their undertaken course and challenging semester examinations and will therefore be invited to take part.
The study is expected to run for 12 months (until May 2020) and the participants will be in the study for approximately 14 weeks. They will need to visit the research site about six times during the study. During this time, patients will receive either a daily dose of the research product or a daily dose of placebo. Which treatment they receive will depend on the randomisation.
REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/0210
Date of REC Opinion
29 Mar 2019
REC opinion
Further Information Favourable Opinion