A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome

Post-Lyme Disease Syndrome (PLDS) Clinical Trial

— PLDS  

Official title:

A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141969
• Other study ID #: RLP10242019
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 29, 2019
• Est. completion date: March 28, 2021

Study information

• Verified date: January 2021
• Source: Optimal Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will determine the effectiveness of a nutraceutical in treating the lingering effects of Lyme Disease after antibiotic treatment.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 28, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Lyme Disease
• Post-Lyme Disease Syndrome (PLDS)
• Syndrome

Intervention

Dietary Supplement:
• RLP
RLP nutraceutical

Other:
• Placebo
Inert brown powder

Locations

Country	Name	City	State
United States	Optimal Health Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Optimal Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS Global-10	PROMIS Global-10; Self reported level changes as measured by the Patient-Reported Outcomes Measurement Information System Global-10 .	6 months
Primary	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