None listed
Conditions
Brief summary
The gastrointestinal tract (GT) is one of the most microbiologically active ecosystems that plays a crucial role in the working of mucosal immune system. Probiotics is a term used to describe beneficial bacteria. The most accepted definition of probiotics was coined by WHO/FAO panel of experts as “live microorganisms that, when administered in appropriate amounts, confer a health benefit on the host”. The most common microorganisms used as probiotics are lactic acid bacteria (LAB), particularly the genus: Lactobacillus spp., Pediococcus spp., and Bifidobacterium spp. Orally administered probiotic bacteria interact with the intestinal epithelial cells (IECs) or immune cells associated with the lamina propria, through Toll-like receptors, and induce the production of different cytokines or chemokines leading to the activation of the mucosal immune system. The aim of this study is to assess the impact of two probiotic strains on biomarkers of immunity, bowel habits, stool consistency, wellbeing, and gut comfort in healthy participants. This is a multi-centre randomised double blind placebo controlled parallel design intervention study involving healthy adult subjects (age 18-50 years) who have volunteered to take part in this study. We aim to recruit 75 volunteers from the general population at both of our study sites in Palmerston North and Auckland. Participants will be randomly allocated into treatment (probiotic 1 and 2) or placebo groups. A baseline blood sample and stool sample will be collected at day 1 of the study and participants will then consume their allocated daily intervention for 4 weeks (28 days). After 4 weeks of consuming their intervention product, participants will be recalled to the clinical research facility for collection of blood and stool samples. During the 4 weeks of the intervention the participants will complete daily bowel habit, stool consistency, wellness and profile of mood questionnaires, and weekly gut comfort and dietary intake questionnaires. Blood samples will be analysed for immune markers and stool samples for markers of gut comfort and health. We hypothesise that probiotics improve human health and wellbeing through immune and gastrointestinal health by enhancing immune responses and intestinal waste elimination.
Interventions
Participants will be randomised to receive only one of the two probiotic strains or placebo.
These will be delivered in oral capsules, one capsule per day for 4 weeks. Maltodextrin is the excipient.
The capsules will each contain Limosilactobacillus or Lactiplantibacillus strains at a dose of 1 x 10 to the power of 10 CFU.
Adherence to the intervention will be monitored through questionnaire and study product return.
Sponsors
New Zealand Institute for Plant & Food Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy adults 18-50 years at recruitment
Exclusion criteria
Blood parameters out of normal health ranges; pregnant or breastfeeding, long term chronic illnesses, daily consumption of probiotics, antibiotic treatment at time of study, recent changes in bowel habit, weight loss, blood in stools anal fissures, bleeding hemorrhoids, and family history of gastrointestinal tract cancer or inflammatory bowel disease.
Outcome results
None listed