Treating gut flora imbalances in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A pilot open label trial examining sex differences and psychological symptoms.

Assessing actigraphic sleep efficiency, Profile of Mood States and Rapid Visual Information Processing for antibiotic and probiotic treatment to reduce gut dysbiosis in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome patients with high Streptococcus: Comparison between sexes.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001077651

Enrollment

Registered

2014-10-09

Start date

2015-07-29

Completion date

2016-11-08

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

An imbalance in gut microorganisms (referred to as gut dysbiosis) has been shown to be related to illness and some ME/CFS symptoms. More research is needed to understand the relationship between the gut and the brain to help with understanding possible causes and treatment options for individuals with ME/CFS. This project will examine how treatment to reduce high levels of Streptococcus bacteria (determined by Bioscreen stool analysis and indicative of abnormal gut functioning) is related to improvements in sleep, mood and cognitive symptoms in individuals with ME/CFS. There is also preliminary evidence to suggest sex differences in response to gut bacteria, thus, this research will examine if there is a sex-differential response to treatment. This is an open-label pilot study that will follow a baseline, treatment and follow-up protocol across 6 weeks. The baseline and follow-up phases are one week each. Possible improvement in sleep, mood and cognition will be measured by using a wrist device (Actiwatch), pen and pencil sleep and day diary, questionnaires and an individual cognitive testing session conducted at Victoria University. A second Bioscreen stool analysis will provide information about changes to gut flora.

Interventions

The Active Treatment Protocol will be combined antibiotic and probiotic therapy for 4 weeks duration. Week 1 = Erythromycin (EES-400mg) - 2 x daily oral capsules Week 2 = Pro4 - 50 D-Lactate Free multistrain probiotic (2 x daily oral capsules) Week 3 = Erythromycin (EES-400mg) - 2 x daily oral capsules Week 4 = Pro4 - 50 D-Lactate Free multistrain probiotic (2 x daily oral capsules) Each capsule of Pro4 - 50 D-Lactate Free multistrain contains: Lactobacillus rhamnosus 25 billion CFUs Bifidobacterium lactis 15 billion CFUs Bifidobacterium breve 5 billion CFUs Bifidobacterium longum 5 billion CFUs Total CFU Count: 50 billion Treatment response and compliance will be monitored by weekly phone calls throughout the intervention phase and assessed through participant self-report questions at the end of the study. The second Bioscreen Faecal Microbial Analysis will provide information about any gut flora changes and will be used in conjunction with participant's self-reported treatment adherence. This treatment protocol is in accordance with current practice at CFSDC. The use of Erythromycin has been TGA approved for Streptococcal infection whilst not specifically indicated for treatment of ME/CFS populations. EES used in this study is not aimed to eradicate faecal streptococcus; but prophylactically to suppress the index organism.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Participants will be patients who have voluntarily presented or been referred to CFSDC. Prospective participants will be: - aged above 18 years - meet the CCC diagnostic criteria for CFS (Carruthers et al., 2003). The CCC is more commonly used to make a diagnosis of ME/CFS in clinical practice. - have higher than normal Streptococcus bacteria count levels as indicated by pathology testing (Bioscreen FMA). High levels of Streptococcus are determined by a viable count reference range above 3.00 x 10(exponent 5) cfu/gm and greater than 5% distribution within aerobic microorganisms. Normal levels are below the aforementioned count and distribution levels. - refrain from taking any other antibiotics for 4 weeks prior and throughout the study period. - refrain from taking any other probiotics for 2 weeks prior and throughout the study period. - agree to refrain from substantially altering their current diet and intake of prescription medication or over-the-counter supplements throughout the 6 week study period - or notify the researchers of any changes required at the time of the change. We will be recruiting equal proportions of male (n = 20) and female (n = 20) participants to evaluate sex-specific treatment responses.

Exclusion criteria

Exclusion criteria are individuals with known adverse reactions to antibiotic/probiotic treatment, concurrent contraindicative medication, or significant comorbid physical or psychiatric illnesses that prevent appropriate completion of the study.

Outcome results