NCT04141969

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

October 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 29, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2021

Completed
Last Updated

April 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

October 25, 2019

Last Update Submit

April 9, 2021

Conditions

Post-Lyme Disease Syndrome (PLDS)

Keywords

Lyme

Outcome Measures

Primary Outcomes (2)

  • PROMIS Global-10

    PROMIS Global-10; Self reported level changes as measured by the Patient-Reported Outcomes Measurement Information System Global-10 .

    6 months

  • IHT Blood Test Assessment

    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.

    6 months

Study Arms (3)

RLP

ACTIVE COMPARATOR

ReaLife+

Dietary Supplement: RLP

Inert

PLACEBO COMPARATOR

Inert brown powder to look similar to RLP

Other: Placebo

Control

NO INTERVENTION

Not given RLP or the placebo

Interventions

RLPDIETARY_SUPPLEMENT

RLP nutraceutical

RLP
PlaceboOTHER

Inert brown powder

Inert

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Non Positive Western Blot test.
  • \. Positive Western Blot test where the individual 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 Osguthorpe, ND

    Optimal Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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

October 25, 2019

First Posted

October 28, 2019

Study Start

November 29, 2019

Primary Completion

December 31, 2020

Study Completion

March 28, 2021

Last Updated

April 12, 2021

Record last verified: 2021-01

Locations

US(1)