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Treating Post-Lyme Disease Syndrome With Acetogenins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04078841
Recruitment Status : Completed
First Posted : September 6, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Optimal Health Research

Study Description
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Brief Summary:
To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS).

Condition or disease Intervention/treatment Phase
Post-Lyme Disease Syndrome (PLDS) Dietary Supplement: ReaLife+ (RLP) Other: Inert Brown powder Phase 1 Phase 2

Detailed Description:
To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS). After failure of antibiotic therapy to relive persistent symptoms of Lyme Disease, the use of Acetogenins to elevate Post-Lyme Disease Syndrome.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Using ReaLife+ to Treat Post-Lyme Disease Syndrome
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : November 14, 2019
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ReaLife+ (RLP)
Dietary Supplement: ReaLife+ (RLP) RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids
 Dietary Supplement: ReaLife+ (RLP)
RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids.
Placebo Comparator: Inert Brown Powder

Brown powder

Inert brown powder to look similar to RLP

 Other: Inert Brown powder
Brown powder Inert brown powder to look similar to RLP
No Intervention: Control
Control


Outcome Measures
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Primary Outcome Measures :
  1. Blood test [ Time Frame: 3 months ]
    Western Blot showing "negative"

  2. PROMIS Fatigue Scale [ Time Frame: 3 months ]
    Self reported fatigue level changes as measured by the Patient-Reported Outcomes Measurement Information System, Fatigue Scale.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A positive Western Blot for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment.

  2. Must be able to swallow and mixed powder drink.

    -

Exclusion Criteria:

  1. Non Positive Western Blot test.

  2. Positive Western Blot test where the indivual has not been treated with antibiotics.

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078841


Locations
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United States, Utah
Optimal Health Research
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
Optimal Health Research
Investigators
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Study Chair: Dr Jeppsen, MD IRB Chair
More Information
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Responsible Party: Optimal Health Research
ClinicalTrials.gov Identifier: NCT04078841    
Other Study ID Numbers: RLP042019
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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