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

Primary Purpose

Post-Lyme Disease Syndrome (PLDS)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RLP
Placebo
Sponsored by
Optimal Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Lyme Disease Syndrome (PLDS) focused on measuring Lyme

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

-

Sites / Locations

  • Optimal Health Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

RLP

Inert

Control

Arm Description

ReaLife+

Inert brown powder to look similar to RLP

Not given RLP or the placebo

Outcomes

Primary Outcome Measures

PROMIS Global-10
PROMIS Global-10; Self reported level changes as measured by the Patient-Reported Outcomes Measurement Information System Global-10 .
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.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2019
Last Updated
April 9, 2021
Sponsor
Optimal Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT04141969
Brief Title
A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome
Acronym
PLDS
Official Title
A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 29, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
March 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Optimal Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Lyme Disease Syndrome (PLDS)
Keywords
Lyme

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RLP
Arm Type
Active Comparator
Arm Description
ReaLife+
Arm Title
Inert
Arm Type
Placebo Comparator
Arm Description
Inert brown powder to look similar to RLP
Arm Title
Control
Arm Type
No Intervention
Arm Description
Not given RLP or the placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
RLP
Intervention Description
RLP nutraceutical
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Inert brown powder
Primary Outcome Measure Information:
Title
PROMIS Global-10
Description
PROMIS Global-10; Self reported level changes as measured by the Patient-Reported Outcomes Measurement Information System Global-10 .
Time Frame
6 months
Title
IHT Blood Test Assessment
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Osguthorpe, ND
Organizational Affiliation
Optimal Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optimal Health Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome

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