Treating Post-Lyme Disease Syndrome With Acetogenins

• ClinicalTrials.gov Identifier: NCT04078841
• Recruitment Status: Completed
• First Posted: September 6, 2019
• Last Update Posted: February 11, 2020
• Sponsor: Optimal Health Research
• Information provided by (Responsible Party): Optimal Health Research

Tracking Information

• First Submitted Date: August 31, 2019
• First Posted Date: September 6, 2019
• Last Update Posted Date: February 11, 2020
• Actual Study Start Date: July 1, 2019
• Actual Primary Completion Date: November 14, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 9, 2019)

• Blood test [ Time Frame: 3 months ]
  Western Blot showing "negative"
• PROMIS Fatigue Scale [ Time Frame: 3 months ]
  Self reported fatigue level changes as measured by the Patient-Reported Outcomes Measurement Information System, Fatigue Scale.

Original Primary Outcome Measures (submitted: August 31, 2019)

• Blood test [ Time Frame: 3 months ]
  Western Blot showing "negative"
• PROMIS Fatigue Scale [ Time Frame: 3 months ]
  Self reported fatigue level changes as measured by the PROMIS Fatigue Scale.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treating Post-Lyme Disease Syndrome With Acetogenins
• Official Title: Using ReaLife+ to Treat Post-Lyme Disease Syndrome
• Brief Summary: To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS).
• 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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Post-Lyme Disease Syndrome (PLDS)

Intervention

• Dietary Supplement: ReaLife+ (RLP)
  RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids.
• Other: Inert Brown powder
  Brown powder Inert brown powder to look similar to RLP

Study Arms

• Active Comparator: ReaLife+ (RLP)
  Dietary Supplement: ReaLife+ (RLP) RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids
  Intervention: Dietary Supplement: ReaLife+ (RLP)
• Placebo Comparator: Inert Brown Powder

  Brown powder

  Inert brown powder to look similar to RLP

  Intervention: Other: Inert Brown powder
• No Intervention: Control
  Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 31, 2019): 30
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 30, 2020
• Actual Primary Completion Date: November 14, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

   -

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04078841
• Other Study ID Numbers: RLP042019
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Optimal Health Research
• Original Responsible Party: Same as current
• Current Study Sponsor: Optimal Health Research
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Dr Jeppsen, MD; IRB Chair

• PRS Account: Optimal Health Research
• Verification Date: February 2020