NCT04078841

Brief Summary

To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

August 31, 2019

Last Update Submit

February 8, 2020

Conditions

Post-Lyme Disease Syndrome (PLDS)

Outcome Measures

Primary Outcomes (2)

  • Blood test

    Western Blot showing "negative"

    3 months

  • PROMIS Fatigue Scale

    Self reported fatigue level changes as measured by the Patient-Reported Outcomes Measurement Information System, Fatigue Scale.

    3 months

Study Arms (3)

ReaLife+ (RLP)

ACTIVE COMPARATOR

Dietary Supplement: ReaLife+ (RLP) RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids

Dietary Supplement: ReaLife+ (RLP)

Inert Brown Powder

PLACEBO COMPARATOR

Brown powder Inert brown powder to look similar to RLP

Other: Inert Brown powder

Control

NO INTERVENTION

Control

Interventions

ReaLife+ (RLP)DIETARY_SUPPLEMENT

RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids.

ReaLife+ (RLP)
Inert Brown powderOTHER

Brown powder Inert brown powder to look similar to RLP

Inert Brown Powder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A positive Western Blot for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment.
  • Must be able to swallow and mixed powder drink.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optimal Health Research

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

Post-Lyme Disease Syndrome

Condition Hierarchy (Ancestors)

Lyme DiseaseGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBorrelia InfectionsSpirochaetales InfectionsTick-Borne DiseasesVector Borne DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Jeppsen, MD

    IRB Chair

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2019

First Posted

September 6, 2019

Study Start

July 1, 2019

Primary Completion

November 14, 2019

Study Completion

January 30, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)