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This study will determine the effectiveness of a nutraceutical in treating the lingering effects of Lyme Disease after antibiotic treatment.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RLP | Active Comparator | ReaLife+ |
|
| Inert | Placebo Comparator | Inert brown powder to look similar to RLP |
|
| Control | No Intervention | Not given RLP or the placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RLP | Dietary Supplement | RLP nutraceutical |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Global-10 | PROMIS Global-10; Self reported level changes as measured by the Patient-Reported Outcomes Measurement Information System Global-10 . | 6 months |
| IHT Blood Test Assessment | 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
1 .Non Positive Western Blot test.
2. Positive Western Blot test where the individual has not been treated with antibiotics.
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| Name | Affiliation | Role |
|---|---|---|
| Dr Osguthorpe, ND | Optimal Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optimal Health Research | Salt Lake City | Utah | 84117 | United States |
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| ID | Term |
|---|---|
| D000077342 | Post-Lyme Disease Syndrome |
| ID | Term |
|---|---|
| D008193 | Lyme Disease |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Other |
Inert brown powder |
|
| D007239 | Infections |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |