Systemic Lupus ErythematosusEarly Phase 1NCT04857151
Stress, Inflammation and Immune Response Pilot Study- Aim 3
A Early Phase 1 study testing App based mindfulness program (ABMP) in people with Systemic Lupus Erythematosus and Inflammation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The overall goal of this study is to investigate the effects of stress and glucose intake at the molecular level including gene expression, protein and functional analysis of immune cells in real time. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus, Inflammation
- What is being tested?
- App based mindfulness program (ABMP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 31 Mar 2024
- Phase
- Early Phase 1
- 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lupus diagnosis according to >4 ACR 1987 criteria or >4 SLICC 2012 criteria or a diagnosis confirmed by a board-certified rheumatologist
- Capacity to provide informed consent and ability to speak and read English
- BMI under 35
- Must have access to an iOS or android smartphone to allow daily use of an app
Who cannot join
- Currently participating in another clinical trial with intervention. Participation in observational clinical trials is not grounds for exclusion.
- History of significant systemic disease (eg. cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinological (diabetes), neurologic, rheumatologic, or gastrointestinal disease)
- Acute illness or evidence of clinically significant active infection
- Pregnant, breast feeding or less than 6 months post-partum
- Taking prescribed psychotropic or central nervous system altering medications
- History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder, epilepsy or seizures
Show all 15Show fewer
- Individuals who are currently undergoing a depressive episode. Can include those who are under treatment and not depressed currently.
- Excluded based upon the screening visit
- Use of nicotine
- Significant previous training or significant current practice in meditation
- Completed Mindfulness Based Stress Reduction (MBSR) in the past
- Current meditation practice. Judgment: Participants will be included or excluded at the PIs discretion due to wide variation in responses (e.g. 2 people answer yes, one practices mindfulness 2x/week for 2 years (exclude), the other attends regular religious services (include))
- Significant daily practice with other mind-body techniques
- Daily Yoga or Tai Chi Practice - exclude
- Other daily practice - judgment
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal of this study is to investigate the effects of stress and glucose intake at the molecular level including gene expression, protein and functional analysis of immune cells in real time.
Aim 1- Characterizing the immune response after acute stress and glucose consumption Aim 2- Temporal mapping of the modulation of immune cell function via meditation Aim 3-Influence of meditative practice on lupus patients Aim 4-Influence of meditative practice on healthy subjects
Current Clinicaltrials.gov record, will be focused on Aim-3 only. Aim-3 will test whether meditation alters neutrophil function and inflammation in patients with lupus. Study team will investigate whether patient neutrophils have altered NET formation, phagocytosis, ROS signaling and migration after ABMP. Innate immune function via analysis of monocytes by flow cytometry will also be analyzed. Other immune cell responses including CD8 T cells will also be investigated.
- Conditions
- Systemic Lupus Erythematosus, Inflammation
- Being tested
- App based mindfulness program (ABMP)
- Keywords
- Neutrophil, Meditation
- Medical subject headings
- Lupus Erythematosus, Systemic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App based mindfulness program (ABMP)Behavioural
App based mindfulness program (ABMP)
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Control |
| App based mindfulness program (ABMP) | Experimental | Participants in this group will participate in App based mindfulness program (ABMP) Receives: Behavioral: App based mindfulness program (ABMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neutrophil function as assessed by Neutrophil extracellular trap(NET) formation
Measured: Baseline and 8 weeks
Change in phagocytic index of neutrophils
Neutrophil phagocytosis is measured by quantifying the ingestion of fluorescent zymosan or E.coli bioparticles using fluorescence microscopy. A phagocytic index is calculated to report the number of particles phagocytosed per cell.
Measured: Baseline and 8 weeks
Change in neutrophil function as assessed by reactive oxygen species (ROS) production
Measured: Baseline and 8 weeks
Change in neutrophils' migratory ability as assessed by change in neutrophils' velocity
Neutrophil migration is assessed using time lapse microscopy. The migration patterns of individual neutrophils are measured using NIH Image J FIJI and velocity (μm/min) is measured.
Measured: Baseline and 8 weeks
Change in neutrophils' migratory ability as assessed by change in "distance travelled" by neutrophils
Neutrophil migration is assessed using time lapse microscopy. The migration patterns of individual neutrophils are measured using NIH Image J FIJI and distance (μm) is quantified.
Measured: Baseline and 8 weeks
Change in the expression of stress-induced genes
Measured: Baseline and 8 weeks
Secondary outcomes (6)
Change in inflammatory cytokines level
Peripheral blood mononuclear cells (PBMC) and sub-populations including CD8 T cells and NK cells will be isolated from blood to study inflammatory cytokines level.
Measured: Baseline and 8 weeks
Change in expression of 'immune cells activation markers'
Measured: Baseline and 8 weeks
Change in the monocyte activation level
Monocytes will be analyzed by flow cytometry for activation markers and other markers of cell function.
Measured: Baseline and 8 weeks
Change in the methylation pattern of stress-induced genes
Measured: Baseline and 8 weeks
Change in the gene expression pattern of stress induced genes
Measured: Baseline and 8 weeks
Change in the cytokine secretion level from immune cells
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start2 Feb 2022
- Primary completion31 Jan 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Beebe, PhD, Principal investigator, UW Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857151
- Sponsor's protocol ID
- 2019-1173- Aim 3
- Other IDs
- PRJ66UV, A536300, SMPH/PATHOL & LAB MED, Protocol version 08/29/2023
- Status last verified
- May 2024
- First submitted
- 8 Apr 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress, Inflammation and Immune Response Pilot Study- Aim 3
- ClinicalTrials.gov ID
- NCT04857151
- Acronym / sponsor ID
- 2019-1173- Aim 3
- Conditions
- Systemic Lupus Erythematosus, Inflammation
- Keywords
- Neutrophil, Meditation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 23 Apr 2021 (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.
The overall goal of this study is to investigate the effects of stress and glucose intake at the molecular level including gene expression, protein and functional analysis of immune cells in real time.
Aim 1- Characterizing the immune response after acute stress and glucose consumption Aim 2- Temporal mapping of the modulation of immune cell function via meditation Aim 3-Influence of meditative practice on lupus patients Aim 4-Influence of meditative practice on healthy subjects
Current Clinicaltrials.gov record, will be focused on Aim-3 only. Aim-3 will test whether meditation alters neutrophil function and inflammation in patients with lupus. Study team will investigate whether patient neutrophils have altered NET formation, phagocytosis, ROS signaling and migration after ABMP. Innate immune function via analysis of monocytes by flow cytometry will also be analyzed. Other immune cell responses including CD8 T cells will also be investigated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Control |
| App based mindfulness program (ABMP) | Experimental | Behavioral: App based mindfulness program (ABMP)Participants in this group will participate in App based mindfulness program (ABMP) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Lupus diagnosis according to >4 ACR 1987 criteria or >4 SLICC 2012 criteria or a diagnosis confirmed by a board-certified rheumatologist
- Capacity to provide informed consent and ability to speak and read English
- BMI under 35
- Must have access to an iOS or android smartphone to allow daily use of an app
Key exclusion criteria (15 listed)
- Currently participating in another clinical trial with intervention. Participation in observational clinical trials is not grounds for exclusion.
- History of significant systemic disease (eg. cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinological (diabetes), neurologic, rheumatologic, or gastrointestinal disease)
- Acute illness or evidence of clinically significant active infection
- Pregnant, breast feeding or less than 6 months post-partum
- Taking prescribed psychotropic or central nervous system altering medications
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 |
|---|---|---|
| App based mindfulness program (ABMP)App based mindfulness program (ABMP) | Behavioural | App based mindfulness program (ABMP) |
Primary outcome
Change in neutrophil function as assessed by Neutrophil extracellular trap(NET) formation
Time frame: Baseline and 8 weeks
Change in phagocytic index of neutrophils
Time frame: Baseline and 8 weeks
Neutrophil phagocytosis is measured by quantifying the ingestion of fluorescent zymosan or E.coli bioparticles using fluorescence microscopy. A phagocytic index is calculated to report the number of particles phagocytosed per cell.
Change in neutrophil function as assessed by reactive oxygen species (ROS) production
Time frame: Baseline and 8 weeks
Change in neutrophils' migratory ability as assessed by change in neutrophils' velocity
Time frame: Baseline and 8 weeks
Neutrophil migration is assessed using time lapse microscopy. The migration patterns of individual neutrophils are measured using NIH Image J FIJI and velocity (μm/min) is measured.
Change in neutrophils' migratory ability as assessed by change in "distance travelled" by neutrophils
Time frame: Baseline and 8 weeks
Neutrophil migration is assessed using time lapse microscopy. The migration patterns of individual neutrophils are measured using NIH Image J FIJI and distance (μm) is quantified.
Change in the expression of stress-induced genes
Time frame: Baseline and 8 weeks
6 secondary outcomes
Change in inflammatory cytokines level
Time frame: Baseline and 8 weeks
Change in expression of 'immune cells activation markers'
Time frame: Baseline and 8 weeks
Change in the monocyte activation level
Time frame: Baseline and 8 weeks
Change in the methylation pattern of stress-induced genes
Time frame: Baseline and 8 weeks
Change in the gene expression pattern of stress induced genes
Time frame: Baseline and 8 weeks
Change in the cytokine secretion level from immune cells
Time frame: Baseline and 8 weeks
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 16 May 2024.
- Individual participant dataSharing planned: No
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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.
David Beebe, PhD principal investigator
UW Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing App based mindfulness program (ABMP) in people with Systemic Lupus Erythematosus and Inflammation, run by University of Wisconsin, Madison 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 4 inclusion and 15 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 16 May 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in neutrophil function as assessed by Neutrophil extracellular trap(NET) formation (time frame: Baseline and 8 weeks). The study lists 6 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 16 May 2024.