An association between changes in the intestinal microbial flora and the alteration of sleep in Chronic Fatigue Syndrome: A pilot open label trial with use of the antibiotic erythromycin

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000457549
• Date of registration: 11/05/2015
• Prospective Registration: No
• Primary sponsor: Victoria University
• Public title: An association between changes in the intestinal microbial flora and the alteration of sleep in Chronic Fatigue Syndrome: A pilot open label trial with use of the antibiotic erythromycin
• Scientific title: Is the Gram Positive status in Faecal Microbial Flora in Chronic Fatigue Syndrome associated with alterations in sleep/daytime functioning? A pilot open label trial with use of antibiotic Erythromycin.
• Date of first enrolment: 09/02/2012
• Target sample size: 30
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000457549.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Melinda Jackson

• Name: Dr Melinda Jackson

Key inclusion & exclusion criteria

Inclusion criteria: meet CFS criteria according to the Canadian consensus documen; be aged over 18 years; have a gram-positive count that met a predetermined threshold (measured through stool test analysis)
Exclusion criteria: currently on antibiotics and/or been on antibiotics for four weeks prior to Baseline phase; been on any non-prescription probiotics for at least 2 weeks prior to Baseline; currently taking any prescription hypnotics (this does not include melatonin); evidence of a sleep disorder (apart from insomnia or hypersomnia); have an Epworth Sleepiness Score >15

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Chronic Fatigue Syndrome;
Chronic Fatigue Syndrome

Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention(s)

Oral tablet of Erythromycin 400mg twice daily for 6 days. Participants note in a daily diary if they did not adhere to the treatment regime at any point during the trial.

Primary Outcome(s)

sleep (measured with actigraphy)[Day 7, 15, 22]

Secondary Outcome(s)

self-reported fatigue levels (Chalder Fatigue Scale)[7, 14, 22 days]

subjective sleep quality[day 22]

Mood (Profile of mood states questionnaire)[Day 7, 15, 22]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Bioscreen (Aust) Pty Ltd

Secondary Sponsor(s)

CFS Discovery

Ethics review

Status: Approved
Approval date:
Contact:

Victoria University Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 11/06/2019
• Date Completed: 30/05/2014