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A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome (PLDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04141969
Recruitment Status : Enrolling by invitation
First Posted : October 28, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Optimal Health Research

Study Description
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Brief Summary:
This study will determine the effectiveness of a nutraceutical in treating the lingering effects of Lyme Disease after antibiotic treatment.

Condition or disease Intervention/treatment Phase
Post-Lyme Disease Syndrome (PLDS) Dietary Supplement: RLP Other: Placebo Phase 2 Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome
Actual Study Start Date : November 29, 2019
Estimated Primary Completion Date : April 14, 2020
Estimated Study Completion Date : April 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: RLP
ReaLife+
 Dietary Supplement: RLP
RLP nutraceutical
Placebo Comparator: Inert
Inert brown powder to look similar to RLP
 Other: Placebo
Inert brown powder
No Intervention: Control
Not given RLP or the placebo


Outcome Measures
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Primary Outcome Measures :
  1. PROMIS Global-10 [ Time Frame: 6 months ]
    PROMIS Global-10; Self reported level changes as measured by the Patient-Reported Outcomes Measurement Information System Global-10 .

  2. IHT Blood Test Assessment [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141969


Locations
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United States, Utah
Optimal Health Research
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
Optimal Health Research
Investigators
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Principal Investigator: Dr Osguthorpe, ND Optimal Health Research
More Information
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Responsible Party: Optimal Health Research
ClinicalTrials.gov Identifier: NCT04141969    
Other Study ID Numbers: RLP10242019
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Optimal Health Research:
Lyme
Additional relevant MeSH terms:
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Lyme Disease
Post-Lyme Disease Syndrome
Syndrome
Disease
Pathologic Processes
 Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections