None listed
Conditions
Brief summary
Probiotics are live microorganisms that help to maintain a healthy microbial composition in the gut. Growing evidence suggests that supporting healthy microbial balance in the gastrointestinal tract with probiotics can modulate the immune response, reduce respiratory infections, and reduce neuroinflammation associated with mood disorders. While there are increasing studies looking at the mechanisms linking gut microbiota to physiological systems that regulate human health and disease, there is a need for high quality randomised controlled trials to investigate the impact of probiotic supplementation in human populations. The aim of this study is to investigate the impact of two lactic acid probiotic strains on psychological wellbeing, common cold and flu symptoms, and gut health in adults, and if probiotic supplementation is associated with changes in biomarkers of immune system function, biomarkers of stress and inflammatory responses, and alterations in the gut microbiome. This is a randomised double blinded controlled parallel intervention study where 765 participants will be recruited (nationwide across New Zealand) and randomly allocated into treatment (probiotic 1 or 2, and at one of the 2 doses) and placebo groups. Participant will consume 1 capsule daily over a period of 8 weeks. During the intervention period, health and wellness data will be collected via questionnaires, SMS and emails. Blood, faecal and saliva samples will be collected for biomarker analysis at base line and end of the study. We hypothesise that probiotic will improve human psychological health and wellbeing, reduce the incidences and duration of the common cold and flu symptoms and negative gastrointestinal symptoms. We also hypothesise that probiotic supplementation in the human population will be associated with the reduction in pro-inflammatory markers normally associated with these health conditions.
Interventions
This is a randomised, double blind, placebo controlled, intervention study with five arms. The study will recruit 765 health adults between the ages 25-65 years old from the general population Nationwide in New Zealand. Participants will be randomly allocated to one of four treatment groups (two lactic acid probiotics strains, each at two different doses - 1x10^9 CFU and 1x10^10 CFU) or placebo.
The duration of the intervention period is 8 weeks, with one oral capsules taken daily with water
This is a randomised, double blind, placebo controlled, intervention study with five arms. The study will recruit 765 health adults between the ages 25-65 years old from the general population Nationwide in New Zealand. Participants will be randomly allocated to one of four treatment groups (two lactic acid probiotics strains, each at two different doses - 1x10^9 CFU and 1x10^10 CFU) or placebo. The duration of the intervention period is 8 weeks, with one oral capsules taken daily with water (cold). The compliance will be monitored by participant returning the bottles with any left over capsules at the end of the study.
Sponsors
Fonterra Research and Development Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy adults aged between 25-65 years Currently living in New Zealand Have access to a smart phone, internet, and computer. Report moderate levels of perceived stress (as indicated by a score of 14 or above on the perceived stress scale).
Exclusion criteria
Are currently taking medication for depression or anxiety prescribed by a doctor Have had antibiotics within the previous four weeks Regularly take probiotics or have taken a probiotic supplement within the last two weeks Have been diagnosed by a doctor with Coeliac Disease, Inflammatory Bowel Disease, or Irritable Bowel Syndrome Pregnant or breastfeeding
Outcome results
None listed