ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12615000457549

Ethics application status

Approved

Date submitted

16/01/2015

Date registered

11/05/2015

Date last updated

11/06/2019

Date data sharing statement initially provided

11/06/2019

Type of registration

Retrospectively registered

Titles & IDs

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.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Fatigue Syndrome

Condition category

Condition code

Other

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

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

sleep (measured with actigraphy)

Timepoint [1]

Day 7, 15, 22

Secondary outcome [1]

Mood (Profile of mood states questionnaire)

Timepoint [1]

Day 7, 15, 22

Secondary outcome [2]

self-reported fatigue levels (Chalder Fatigue Scale)

Timepoint [2]

7, 14, 22 days

Secondary outcome [3]

subjective sleep quality

Timepoint [3]

day 22

Eligibility

Key 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)

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Repeated measures ANOVA; Wilcoxon tests; Spearman's correlations. This is a pilot study so no sample size estimates were performed.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2011

Actual

9/02/2012

Date of last participant enrolment

Anticipated

21/12/2012

Actual

15/01/2014

Date of last data collection

Anticipated

Actual

30/05/2014

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Bioscreen (Aust) Pty Ltd

Address [1]

University Drive, Parkville
Victoria, 3052

Country [1]

Australia

Primary sponsor type

University

Name

Victoria University

Address

PO Box 14428
Melbourne, Victoria 8001

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

CFS Discovery

Address [1]

90 Mitcham Road, Donvale VIC 3111

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Victoria University Human Research Ethics Committee

Ethics committee address [1]

PO Box 14428 
Melbourne VIC 8001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/05/2011

Ethics approval number [1]

11_64

Summary

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.

Trial website

Trial related presentations / publications

Jackson ML, Bruck D, Ball M, Butt H, Lewis D. (2013). 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. Sleep and Biological Rhythms, 11 (Supp 2): 55.

Jackson ML, Bruck D. (2012). Sleep abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A review. Journal of Clinical Sleep Medicine 8(6): 719-728.

Public notes

Contacts

Principal investigator

Name

Prof Dorothy Bruck

Address

Victoria University
College of Arts
Footscray Park Campus
PO Box 14428
Melbourne, VIC 8001

Country

Australia

Phone

+613 9919 2158

Fax

[email protected]

Contact person for public queries

Name

Melinda Jackson

Address

School of Health Sciences
RMIT University
Bundoora, VIC 3083

Country

Australia

Phone

+613 99257564

Fax

[email protected]

Contact person for scientific queries

Name

Melinda Jackson

Address

School of Health Sciences
RMIT University
Bundoora, VIC 3083

Country

Australia

Phone

+613 99257564

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Sleep quality and the treatment of intestinal micro biota imbalance in chronic fatigue syndrome: A pilot study.	2015	https://dx.doi.org/10.1016/j.slsci.2015.10.001

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically