Trial of the functional food Biobran in patients with 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. CONDITION: Persistent symptoms attributed to Lyme borreliosis ; Infections and Infestations ; Lyme disease PRIMARY OUTCOME: Immune system functioning, assessed using flow cytometry at baseline and three‐month follow‐up SECONDARY OUTCOME: 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 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