Trial of the functional food Biobran in patients with persistent symptoms attributed to Lyme borreliosis

Not Applicable

• Conditions: Persistent symptoms attributed to Lyme borreliosis; Infections and Infestations; Lyme disease

• Registration Number: ISRCTN31318565
• Lead Sponsor: Daiwa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-28
• Last Update Posted: 16 October 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

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

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

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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

Study & Design

• Study Type: Interventional
• Study Design: Not specified