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

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000457549

Enrollment

Registered

2015-05-11

Start date

2012-02-09

Completion date

2014-01-15

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

Recent important discoveries reinforce the idea that CFS is associated with gut flora imbalances. However, the idea that this can have a major effect on sleep and daytime functioning requires further supporting research. This project will determine whether those participants with CFS who, at baseline, are highly gram-positive (determined via stool analysis and indicative of abnormal gut functioning) and respond to antibiotic treatment (such that the amount of gram positive flora is reduced below a certain threshold) also demonstrate significant and ongoing improvements in sleep, daytime activity, mood and self-reported fatigue symptoms. Eligible participants will follow a baseline, treatment and follow up protocol, across a total of 22 days. The treatment phase involves taking a course of the antibiotic, Erythromycin, for 6 days. This is an open label pilot research program which aims to determine whether this treatment leads to improvements during treatment and follow up phases, compared to assessments made in the baseline phase. A second Bioscreen stool analysis will also determine whether reduced gram-positive status has been achieved in the gut.

Interventions

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.

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 80 Years

Healthy volunteers

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

Outcome results