None listed
Conditions
Brief summary
Chronic Fatigue Syndrome (CFS) is a debilitating disorder characterised by fatigue that does not improve with rest, physical symptoms of pain, nausea, fatigue, dizziness, headaches and post exertional malaise which is a worsening of CFS symptoms following minimal physical or mental effort. In young people, CFS can disrupt typical adolescent development by impacting a young person’s ability to attend school, socialise with peers, and maintain physical activity. Rates of depression and anxiety are also higher in those with CFS. Currently there is no treatment for CFS and patients are encouraged to manage symptoms. Gut microbiota are the colony of bacteria, fungi and viruses that live in the gastrointestinal tract and play a role in physiological processes in the body. The microbiota-gut-brain-axis refers to multiple bi-directional relationships between the microbes in the gut and the brain. Evidence suggests that disruption to the balance of beneficial versus pathological microbes in the gut (dysbiosis) is present in chronic fatigue, depression and anxiety. Probiotics, defined as live microorganisms that confer a benefit to the host when consumed, are one way in which the healthy balance of microbes can be restored in the gut. Preliminary studies have suggested that supplementation with probiotics can improve psychological well-being in people with CFS. To date there have not been any studies of the effect of probiotics in adolescents with CFS. This study aims to determine whether probiotic supplementation improves the psychological wellbeing of adolescents with CFS using a randomised, double blind placebo controlled intervention that comprises a 10-week supplementation period with a combination of the probiotics Lactobacillus rhamnosus HN001 and Bifidobacterium animalis HN019.
Interventions
Participants who are randomly assigned to the intervention group will receive capsules containing both the probiotics Lactobacillus rhamnosus HN001 (6X109 colony forming units) and Bifidobacterium animalis HN019 ((9×109 cfu) in the same capsule.
Participants will be instructed to take one single capsule a day for a period of 10 weeks.
Adherence will be assessed by asking participants to enter the number of remaining capsules they have in the bottle at the post-intervention data collection phas
Participants who are randomly assigned to the intervention group will receive capsules containing both the probiotics Lactobacillus rhamnosus HN001 (6X109 colony forming units) and Bifidobacterium animalis HN019 ((9×109 cfu) in the same capsule. Participants will be instructed to take one single capsule a day for a period of 10 weeks. Adherence will be assessed by asking participants to enter the number of remaining capsules they have in the bottle at the post-intervention data collection phase.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
13 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Young people aged 13-18 years with a diagnosis of chronic fatigue syndrome made by a doctor. The availability of a parent/caregiver is not a key inclusion criteria. Having a parent/caregiver available to answer questionnaires is preferred but not a requirement for a young person to participate in the study.
Exclusion criteria
1. Taking probiotics regularly 2. On immunosuppressant therapy 3. Participation in another intervention trial for CFS
Outcome results
None listed