Condition category
Infections and Infestations
Date applied
25/06/2017
Date assigned
28/06/2017
Last edited
27/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Lyme disease is a bacterial infection spread to humans by infected ticks. This study focuses on boosting the immune system of Lyme disease patients using a food supplement called Biobran - a water-soluble rice bran extract. The aim of this study is to investigate whether daily supplementation with Biobran over three months improves immune system functioning in patients with persistent symptoms due to Lyme disease.

Who can participate?
Patients aged 18 or over with Lyme disease and healthy volunteers aged 18 or over

What does the study involve?
Both patients and healthy volunteers undergo an assessment in central London which includes a clinical history, questionnaires, a physical examination, electrocardiogram (ECG), cognitive testing and a blood test. This takes a morning or afternoon. The patients are randomly allocated to be given either Biobran or a placebo (dummy supplement) to take daily for three months. There are two telephone follow-up calls during this time. At the end of three months, another assessment takes place in central London, which will be similar to the first one.

What are the possible benefits and risks of participating?
Possible benefits include undergoing a medical assessment, including a medical history, physical examination and ECG, which might indicate the presence of a previously unknown or unsuspected clinically relevant finding. There are no anticipated possible risks.

Where is the study run from?
Medical Express Clinic (UK)

When is the study starting and how long is it expected to run for?
August 2016 to December 2018

Who is funding the study?
Daiwa (Japan)

Who is the main contact?
Prof. Basant Puri

Trial website

www.lymeresearch.uk

Contact information

Type

Scientific

Primary contact

Prof Basant Puri

ORCID ID

http://orcid.org/0000-0001-6101-0139

Contact details

Imaging Directorate
Block A
Level 1
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V2

Study information

Scientific title

Randomised, double-blind, placebo-controlled three-month trial of Biobran MGN-3 in patients with persistent symptoms attributed to Lyme borreliosis

Acronym

Study hypothesis

There is good evidence that the functional food Biobran MGN-3 is a safe immunomodulator which enhances NK cell activity, enhances human T lymphocyte and human B lymphocyte proliferation, enhances phagocytosis of bacteria, enhances the oxidative burst in human neutrophils and monocytes, and enhances the production of the cytokines TNF-α, IL-6, IL-8 and IL-10. It is therefore hypothesised that regular daily intake of this functional food will be associated with improved immune system functioning in patients with persistent symptoms attributed to Lyme borreliosis.

Ethics approval

AONMREC (The Academy of Nutritional Medicine Research Ethics Committee), 22/02/2017, ref: 0217

Study design

Single-centre randomised double-blind placebo-controlled three-month trial (the baseline data [patients versus controls] will constitute an initial cross-sectional cohort study)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Persistent symptoms attributed to Lyme borreliosis

Intervention

Following the baseline assessment of the patients and controls, each patient will be randomly allocated to either the active group or the placebo group, in a one-to-one allocation ratio. This randomisation will be computerised and balanced by minimisation for age, sex and duration of symptoms. The researchers directly involved in the study and the participants will be blinded to group allocation.

1. Active: Biobran MGN-3 at a dose of 3 grams daily for three months. Administration: oral
2. Placebo: of identical appearance and taste to the active intervention, and isocaloric with the active intervention. Administration: oral

Measurements will be made at two timepoints, namely at baseline and at three-month follow-up.

Intervention type

Phase

Drug names

Primary outcome measures

Immune system functioning, assessed using flow cytometry at baseline and three-month follow-up

Secondary outcome measures

1. Electrocardiographic function, assessed using electrocardiography
2. Neuropsychological outcome, assessed using the Cambridge Neuropsychological Test Automated Battery. The questionnaires will be as follows:
2.1. Rheumatoid Arthritis Severity Scale (RASS) (Bardwell et al., 2002)
2.2. Epworth Sleepiness Scale (Johns, 1991)
2.3. Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q) (Coyne et al., 2002)
2.4. Refined and Abbreviated Composite Autonomic Symptom Score (COMPASS 31) (Sletten et al., 2012)
2.5. Modified Chalder Fatigue Scale (CFQ) (Chalder et al., 1993)
2.6. Fatigue Severity Scale (FSS) (Krupp et al., 1989)
2.7. Pain Visual Analogue Scale (VAS) (Portenoy and Kanner, 1996)
2.8. McGill Pain Questionnaire (MPQ) (Melzack, 1975)
2.9. Tinnitus Handicap Inventory (THI) (Newman et al., 1996)
3. Course of Lyme disease symptomatology, assessed by history taking, clinical examination and the use of questionnaires
Assessments made at baseline and three-month follow-up

Overall trial start date

29/08/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

For the patients, the inclusion criteria will be as follows:
1. Meeting the diagnostic criteria for the syndrome of Borrelia-associated persistent symptoms used by the Persistent Lyme Empiric Antibiotic Study Europe (PLEASE); PLEASE criterion 2B will be extended to include other appropriate laboratory tests including the Elispot. PLEASE criterion #1 specifies that the subjects must be males or non-pregnant, non-lactating females who are 18 years of age or older

For the controls, the inclusion criteria will be as follows:
1. Healthy males or non-pregnant, non-lactating females who are 18 years of age or older

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

104 (comprising 52 patients and 52 controls)

Participant exclusion criteria

For the patients, the exclusion criteria will be as follows.
1. A history of hypersensitivity to Biobran MGN-3
2. Having received > 5 days’ antimicrobial therapy during the previous four weeks
3. Regularly taking Biobran MGN-3 during the previous four weeks
4. Current enrolment in another clinical trial
5. Currently receiving other antimicrobial therapy
6. An inability to give full informed consent

For the controls, the exclusion criteria will be as follows.
1. Suffering from Lyme disease or a major neuropsychiatric disorder
2. Being the child of a known Lyme disease affected mother
3. Being in a non-platonic relationship with a known Lyme disease patient

Recruitment start date

30/06/2017

Recruitment end date

28/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medical Express Clinic
W1G 6AT

Sponsor information

Organisation

Daiwa

Sponsor details

1-16-19 Sangenjaya
Setagaya-ku
Tokyo
#154-0024
Japan

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Daiwa

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The findings of the study will be communicated to colleagues and the public in lectures, academic journals and public talks. The baseline data, from baseline assessments of the patients and controls, will be analysed first; it is intended that these results be submitted for publication from the last quarter of 2017 onwards. The overall trial results will not be available until the group allocation coding is broken, which will be at the end of the final assessment of the final patient; the corresponding results will be submitted for publication after this date.

IPD sharing statement
The datasets will not be made available in order fully to ensure patient confidentiality. Consent forms, questionnaires and identifying information will be kept in a locked filing cabinet and only the investigators involved in the study will have a key. All data will be rendered anonymous on entry into spreadsheets and statistical analysis software and held in password-protected hardware. Hard copies of data will be kept in locked filing cabinets and only the investigators involved in the study will have a key.

Intention to publish date

01/09/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes