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

Not Applicable

Completed

• Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12614001077651
• Lead Sponsor: CFS Discovery Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean actigraphic sleep efficiency score[At baseline and post-intervention (week 5 after conclusion of the 4 week intervention)];Profile of Mood Scale (POMS) mean scores[At baseline and post-intervention (week 5 after conclusion of the 4 week intervention)];Mean Rapid Visual Information Processing (RVP) on CANTAB[At baseline and post-intervention (week 5 after conclusion of the 4 week intervention)]