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
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
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