Persistent symptoms attributed to Lyme borreliosis Infections and Infestations Lyme disease
Conditions
Interventions
Current interventions as of 18/08/2022:
Following baseline assessment, each patient will be randomly allocated to either the active group or the placebo group, in a one-to-one allocation ratio. This r
Sponsors
Daiwa
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 18/08/2022: 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 7. Currently pregnant or breastfeeding _____ Previous 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 18/08/2022: Immune system functioning measured using RNA-seq and flow cytometry at baseline and three-month follow-up _____ Previous primary outcome measure: Immune system functioning, assessed using flow cytometry at baseline and three-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 18/08/2022: 1. The following questionnaires will be administered at baseline and three-month follow-up: 1.1. Epworth Sleepiness Scale (Johns, 1991) 1.2. Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q) (Coyne et al., 2002) 1.3. Refined and Abbreviated Composite Autonomic Symptom Score (COMPASS 31) (Sletten et al., 2012) 1.4. Modified Chalder Fatigue Scale (CFQ) (Chalder et al., 1993) 1.5. Fatigue Severity Scale (FSS) (Krupp et al., 1989) 1.6. Pain Visual Analogue Scale (VAS) (Portenoy and Kanner, 1996) 1.7. McGill Pain Questionnaire (MPQ) (Melzack, 1975) 1.8. Tinnitus Handicap Inventory (THI) (Newman et al., 1996) 2. Course of Lyme disease symptomatology, assessed by history taking, clinical examination and the use of questionnaires at baseline and three-month follow-up _____ Previous secondary outcome measure: 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 | — |
Countries
United Kingdom
Outcome results
None listed