Post-Lyme Disease Syndrome (PLDS)
Conditions
Keywords
Lyme
Brief summary
This study will determine the effectiveness of a nutraceutical in treating the lingering effects of Lyme Disease after antibiotic treatment.
Detailed description
A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome will be evaluated during a double blind, placebo controlled study. This study is an expansion of RLP042019 NCT04078841 Treating Post-Lyme Disease Syndrome With Acetogenins
Interventions
DIETARY_SUPPLEMENTRLP
RLP nutraceutical
OTHERPlacebo
Inert brown powder
Sponsors
Optimal Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. A positive two-test methodology using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay as a first test, followed by a western immunoblot assay for specimens yielding positive or equivocal results for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment. 2. Must be able to swallow a mixed powder drink.
Exclusion criteria
1 .Non Positive Western Blot test. 2\. Positive Western Blot test where the individual has not been treated with antibiotics. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Global-10 | 6 months | PROMIS Global-10; Self reported level changes as measured by the Patient-Reported Outcomes Measurement Information System Global-10 . |
| IHT Blood Test Assessment | 6 months | Outcome measure of positive or negative for antibodies; IgG P93 Ab. IgG P66 Ab. IgG P58 Ab. IgG P45 Ab. IgG P41 Ab. IgG P39 Ab. IgG P30 Ab. IgG P28 Ab. IgG P23 Ab. IgG P18 Ab. |
Countries
United States
Outcome results
None listed