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Completed

NCT Number: NCT04141969

A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome

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

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Key information

Conditions

Post-Lyme Disease Syndrome (PLDS) Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Chronic Disease Disease Attributes Gram-Negative Bacterial Infections Infections Lyme Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Infectious Disorders Post-Lyme Disease Syndrome Spirochaetales Infections Tick-Borne Diseases Vector Borne Diseases

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Optimal Health Research

Salt Lake City, Utah, 84117, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

  • Positive Western Blot test where the individual has not been treated with antibiotics.

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Treatment and study plan

RLP

Dietary Supplement

RLP nutraceutical

Placebo

Other

Inert brown powder

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Optimal Health Research

Other

Registry information

Acronym: PLDS

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Oct 28, 2019
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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