A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome

Phase 2

Completed

• Conditions: Post-Lyme Disease Syndrome (PLDS)
• Interventions: Dietary Supplement: RLP; Other: Placebo

• Registration Number: NCT04141969
• Lead Sponsor: Optimal Health Research

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

Study Timeline

• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-28
• Study Start: 2019-11-29
• Primary Completion: 2020-12-31
• Status Verified: 2021-01
• Study Completion: 2021-03-28
• Last Update Submitted: 2021-04-09
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RLP	RLP	ReaLife+
Inert	Placebo	Inert brown powder to look similar to RLP

Primary Outcome Measures

Name	Time	Method
PROMIS Global-10	6 months	PROMIS Global-10; Self reported level changes as measured by the Patient-Reported Outcomes Measurement Information System Global-10 .
IHT Blood Test Assessment	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.

Trial Locations

Locations (1)

Optimal Health Research; 🇺🇸 Salt Lake City, Utah, United States