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

• ClinicalTrials.gov Identifier: NCT04141969
• Recruitment Status: Completed
• First Posted: October 28, 2019
• Last Update Posted: April 12, 2021
• Sponsor: Optimal Health Research
• Information provided by (Responsible Party): Optimal Health Research

Study Description

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

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Primary Completion Date: December 31, 2020
• Actual Study Completion Date: March 28, 2021

Arms and Interventions

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

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

• 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

Locations

United States, Utah

Optimal Health Research

Salt Lake City, Utah, United States, 84117

Sponsors and Collaborators

Optimal Health Research

Investigators

• Principal Investigator: Dr Osguthorpe, ND; Optimal Health Research

More Information

• Responsible Party: Optimal Health Research
• ClinicalTrials.gov Identifier: NCT04141969
• Other Study ID Numbers: RLP10242019
• First Posted: October 28, 2019
• Last Update Posted: April 12, 2021
• Last Verified: January 2021

• 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:

Lyme Disease; Post-Lyme Disease Syndrome; Syndrome; Disease; Pathologic Processes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases