Post-Lyme Disease Syndrome (PLDS)Phase 1/2NCT04078841
Treating Post-Lyme Disease Syndrome With Acetogenins
A Phase 1/2 study testing ReaLife+ (RLP) and Inert Brown powder in people with Post-Lyme Disease Syndrome (PLDS), run by Optimal Health Research at 1 site in United States.
Trial summary
To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Lyme Disease Syndrome (PLDS)
- What is being tested?
- ReaLife+ (RLP) and Inert Brown powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 Jan 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- Non Positive Western Blot test.
- Positive Western Blot test where the indivual has not been treated with antibiotics.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using ReaLife+ to Treat Post-Lyme Disease Syndrome
To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS).
Read the 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.
- Conditions
- Post-Lyme Disease Syndrome (PLDS)
- Being tested
- ReaLife+ (RLP), Inert Brown powder
- Medical subject headings
- Post-Lyme Disease Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReaLife+ (RLP)Dietary supplement
RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids.
Inert Brown powderOther
Brown powder Inert brown powder to look similar to RLP
| Study group | Role | What they receive |
|---|---|---|
| ReaLife+ (RLP) | Active comparator | Dietary Supplement: ReaLife+ (RLP) RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids Receives: Dietary Supplement: ReaLife+ (RLP) |
| Inert Brown Powder | Placebo comparator | Brown powder
Inert brown powder to look similar to RLP Receives: Other: Inert Brown powder |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood test
Western Blot showing "negative"
Measured: 3 months
PROMIS Fatigue Scale
Self reported fatigue level changes as measured by the Patient-Reported Outcomes Measurement Information System, Fatigue Scale.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jul 2019
- Primary completion14 Nov 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Lyme Disease Syndrome (PLDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimal Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Jeppsen, MD, Study chair, IRB Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078841
- Sponsor's protocol ID
- RLP042019
- Status last verified
- Feb 2020
- First submitted
- 31 Aug 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using ReaLife+ to Treat Post-Lyme Disease Syndrome
- ClinicalTrials.gov ID
- NCT04078841
- Acronym / sponsor ID
- RLP042019
- Conditions
- Post-Lyme Disease Syndrome (PLDS)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Optimal Health ResearchUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ReaLife+ (RLP) | Active comparator | Dietary Supplement: ReaLife+ (RLP)Dietary Supplement: ReaLife+ (RLP) RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids |
| Inert Brown Powder | Placebo comparator | Other: Inert Brown powderBrown powder Inert brown powder to look similar to RLP |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- -
Key exclusion criteria (3 listed)
- Non Positive Western Blot test.
- Positive Western Blot test where the indivual has not been treated with antibiotics.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReaLife+ (RLP)RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids. | Dietary supplement | ReaLife+ (RLP) |
| Inert Brown powderBrown powder Inert brown powder to look similar to RLP | Other | Inert Brown Powder |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Jeppsen, MD study chair
IRB Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ReaLife+ (RLP) and Inert Brown powder in people with Post-Lyme Disease Syndrome (PLDS), run by Optimal Health Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood test (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.