MicrobiomeNCT05510050
Comparison Study of Manapol and DaltonMax on Immune Function, Microbiome, and Related Variables in Men and Women
A study testing Aloe Vera Extract 1 and Aloe Vera Extract 2 in people with Microbiome and Immune Function, run by University of Memphis at 1 site in United States.
Trial summary
The present study will compare the effect of Manapol to DaltonMax on select measures of health. Currently, both ingredients are sold both as a stand-alone dietary supplement and as an active ingredient within various multi-nutrient products. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiome, Immune Function
- What is being tested?
- Aloe Vera Extract 1 and Aloe Vera Extract 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2022to 3 Mar 2023
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no consumption of alcohol-containing beverages within 48 hours of testing
- no consumption of caffeine-containing beverages within 48 hours of testing
- no strenuous exercise within 48 hours of testing
- be able to fast overnight (>10 hrs)
Who cannot join
- self-reported active infection or illness of any kind
- diabetic
- diagnosed with an autoimmune disease including but not limited to rheumatoid arthritis, lupus, Multiple sclerosis, Guillain-Barre syndrome, Psoriasis
- diagnosed GI-related health problems
- using tobacco products
- allergic or hypersensitive to aloe vera
Show all 9Show fewer
- if female, pregnant or lactating
- using antibiotics
- using a medication/dietary supplement that alters immune or digestive function or that might otherwise impact study outcomes including, but not limited to supplements with immune, immunity, or defense in their name, immunosuppressants including Cyclosporines (Neoral®, Gengraf®, Sandimmune®), Tacrolimus (Prograf®, FK506), Mycophenolate mofetil (CellCept®), Prednisone, Azathioprine (Imuran®), Sirolimus (Rapamune®), Daclizumab and Basiliximab (Zenapax® and Simulect®), OKT3® (monoclonal antibody), Anti-Fungal Medications (Mycelex Troche®, Nystatin® Swish and Swallow, and Diflucan®), Antiviral Medications: Zovirax® (acyclovir), Cytovene® (ganciclovir), and Valcyte® (valganciclovir), Diuretics: Lasix® (furosemide), Antibiotics: Bactrim® (septra), Anti-Ulcer Medications: Prilosec® (omeprazole), Prevacid® (lansoprazole), Zantac® (ranitidine), Axid® (nizatidine), Carafate®(sucralfate), Pepcid®
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38156
About this study
The present study will compare the effect of Manapol to DaltonMax on select measures of health. Currently, both ingredients are sold both as a stand-alone dietary supplement and as an active ingredient within various multi-nutrient products.
Immune function will be assessed using blood samples to determine white blood cell counts and distributions, and cytokine levels with/without lipopolysaccharide (LPS) challenge. Additionally, effects specific to antioxidant function and glucose regulation, glucose, insulin, lipid peroxidation, and advanced oxidation protein products will be observed. Antioxidant capacity will also be measured. as well as completion of weekly questionnaires regarding gut health, and microbiome analysis.
Read the detailed description
Previous research has identified many beneficial properties of aloe vera extracts on health including the "induction of apoptosis, hepatoprotection, antioxidant, antibacterial, antidiabetic, antihyperglycemic, and anti-inflammatory effects". Further, aloe vera may ameliorate digestive issues such as irritable bowel syndrome, as indicated in a recent meta-analysis, although findings are somewhat inconsistent across studies and may be dependent on aloe form and dosage.
The present study will compare the effect of Manapol to DaltonMax on select measures of health. Currently, both ingredients are sold both as a stand-alone dietary supplement and as an active ingredient within various multi-nutrient products.
Immune function will be assessed using blood samples to determine white blood cell counts and distributions, and cytokine presence (IL-1β, IL-6, IL-10, TNF-alpha) with/without lipopolysaccharide (LPS) challenge. Additionally, aloe has been noted to have multiple effects specific to antioxidant function and glucose regulation, glucose, insulin, lipid peroxidation, and advanced oxidation protein products. An increase in blood antioxidant capacity was noted in an earlier study of Ambrotose, therefore antioxidant capacity will also be measured. As prior studies of aloe, coupled with anecdotal reports, provide evidence specific to a potential benefit to gut health, subjects will complete weekly questionnaires regarding gut health, and have a microbiome analysis performed.
- Conditions
- Microbiome, Immune Function
- Being tested
- Aloe Vera Extract 1, Control, Aloe Vera Extract 2
- Keywords
- Aloe Vera extract, Manapol, Dalton Max
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aloe Vera Extract 1Dietary supplement
2 capsules taken daily for 30 days
ControlDietary supplement
2 capsules taken daily for 30 days
Aloe Vera Extract 2Dietary supplement
2 capsules taken daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Manapol | Experimental | 1000 mg (Manapol only) Aloe Vera extract daily Receives: Dietary Supplement: Aloe Vera Extract 1 |
| Dalton Max | Experimental | 1000 mg (Dalton Max only) Aloe Vera extract daily Receives: Dietary Supplement: Aloe Vera Extract 2 |
| Placebo | Placebo comparator | Placebo (rice dextrin or similar) taken daily Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
White blood cell characterization
A blood sample will be used to characterize the white blood cell population (cell count and distribution)
Measured: baseline
White blood cell characterization
A blood sample will be used to characterize the white blood cell population (cell count and distribution)
Measured: on day 30 of treatment
Cytokine Panel for plasma
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma
Measured: baseline
Cytokine Panel for plasma
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma
Measured: on day 30 of treatment
Cytokine Panel on LPS stimulated whole blood
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified on whole blood treated with LPS
Measured: baseline
Cytokine Panel on LPS stimulated whole blood
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified on whole blood treated with LPS
Measured: on day 30 of treatment
Glucose
Glucose levels in blood will be measured
Measured: baseline
Glucose
Glucose levels in blood will be measured
Measured: on day 30 of treatment
Insulin
Insulin levels in a blood sample will be measured
Measured: baseline
Insulin
Insulin levels in a blood sample will be measured
Measured: on day 30 of treatment
Lipid peroxidation
Lipid peroxiation in a blood sample will be quantified
Measured: baseline
Lipid peroxidation
Lipid peroxiation in a blood sample will be quantified
Measured: on day 30 of treatment
Advanced oxidation protein products
Advanced oxidation protein products in a blood sample will be quantified
Measured: baseline
Advanced oxidation protein products
Advanced oxidation protein products in a blood sample will be quantified
Measured: on day 30 of treatment
Blood antioxidant capacity
Blood antioxidant capacity will be quantified from a blood sample
Measured: baseline
Blood antioxidant capacity
Blood antioxidant capacity will be quantified from a blood sample
Measured: on day 30 of treatment
Self-reported assessment of fatigue & associated variables
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Measured: baseline
Self-reported assessment of fatigue & associated variables
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Measured: Week 1 of treatment
Self-reported assessment of fatigue & associated variables
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Measured: Week 2 of treatment
Self-reported assessment of fatigue & associated variables
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Measured: Week 3 of treatment
Self-reported assessment of fatigue & associated variables
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Measured: Week 4 of treatment
Subjects' perceived digestive/bowel health
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Measured: baseline
Subjects' perceived digestive/bowel health
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Measured: Week 1 of treatment
Subjects' perceived digestive/bowel health
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Measured: Week 2 of treatment
Subjects' perceived digestive/bowel health
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Measured: Week 3 of treatment
Subjects' perceived digestive/bowel health
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Measured: Week 4 of treatment
Microbiome analysis
Subjects will submit a stool sample kit for microbiome analysis
Measured: baseline
Microbiome analysis
Subjects will submit a stool sample kit for microbiome analysis
Measured: on Day 30 of treatment
Secondary outcomes (6)
Food Logs
Subjects will record their dietary consumption for the 5 days leading up to each test visit
Measured: baseline
Food Logs
Subjects will record their dietary consumption for the 5 days leading up to each test visit
Measured: on Day 30 of treatment
Resting Blood Pressure
Blood pressure will be measured following a 10 min rest using an automated system
Measured: baseline
Resting Blood Pressure
Blood pressure will be measured following a 10 min rest using an automated system
Measured: on Day 30 of treatment
Resting Heart Rate
Heart rate will be measured following a 10 min rest using an automated system
Measured: baseline
Resting Heart Rate
Heart rate will be measured following a 10 min rest using an automated system
Measured: on day 30 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start13 May 2022
- Primary completion3 Nov 2022
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiomeStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Mannatech
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510050
- Sponsor's protocol ID
- PRO-FY2022-131
- Status last verified
- Sep 2023
- First submitted
- 19 Aug 2022
- Last updated
- 26 Sep 2023
- 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of Manapol and DaltonMax on Immune Function, Microbiome, and Related Variables in Men and Women
- ClinicalTrials.gov ID
- NCT05510050
- Acronym / sponsor ID
- PRO-FY2022-131
- Conditions
- Microbiome, Immune Function
- Keywords
- Aloe Vera extract, Manapol, Dalton Max
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Mannatech
- Study start
- 13 May 2022 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 22 Aug 2022 (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 present study will compare the effect of Manapol to DaltonMax on select measures of health. Currently, both ingredients are sold both as a stand-alone dietary supplement and as an active ingredient within various multi-nutrient products.
Immune function will be assessed using blood samples to determine white blood cell counts and distributions, and cytokine levels with/without lipopolysaccharide (LPS) challenge. Additionally, effects specific to antioxidant function and glucose regulation, glucose, insulin, lipid peroxidation, and advanced oxidation protein products will be observed. Antioxidant capacity will also be measured. as well as completion of weekly questionnaires regarding gut health, and microbiome analysis.
Detailed description
Previous research has identified many beneficial properties of aloe vera extracts on health including the "induction of apoptosis, hepatoprotection, antioxidant, antibacterial, antidiabetic, antihyperglycemic, and anti-inflammatory effects". Further, aloe vera may ameliorate digestive issues such as irritable bowel syndrome, as indicated in a recent meta-analysis, although findings are somewhat inconsistent across studies and may be dependent on aloe form and dosage.
The present study will compare the effect of Manapol to DaltonMax on select measures of health. Currently, both ingredients are sold both as a stand-alone dietary supplement and as an active ingredient within various multi-nutrient products.
Immune function will be assessed using blood samples to determine white blood cell counts and distributions, and cytokine presence (IL-1β, IL-6, IL-10, TNF-alpha) with/without lipopolysaccharide (LPS) challenge. Additionally, aloe has been noted to have multiple effects specific to antioxidant function and glucose regulation, glucose, insulin, lipid peroxidation, and advanced oxidation protein products. An increase in blood antioxidant capacity was noted in an earlier study of Ambrotose, therefore antioxidant capacity will also be measured. As prior studies of aloe, coupled with anecdotal reports, provide evidence specific to a potential benefit to gut health, subjects will complete weekly questionnaires regarding gut health, and have a microbiome analysis performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, double-blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Manapol | Experimental | Dietary Supplement: Aloe Vera Extract 11000 mg (Manapol only) Aloe Vera extract daily |
| Dalton Max | Experimental | Dietary Supplement: Aloe Vera Extract 21000 mg (Dalton Max only) Aloe Vera extract daily |
| Placebo | Placebo comparator | Dietary Supplement: ControlPlacebo (rice dextrin or similar) taken daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- no consumption of alcohol-containing beverages within 48 hours of testing
- no consumption of caffeine-containing beverages within 48 hours of testing
- no strenuous exercise within 48 hours of testing
- be able to fast overnight (>10 hrs)
Key exclusion criteria (9 listed)
- self-reported active infection or illness of any kind
- diabetic
- diagnosed with an autoimmune disease including but not limited to rheumatoid arthritis, lupus, Multiple sclerosis, Guillain-Barre syndrome, Psoriasis
- diagnosed GI-related health problems
- using tobacco products
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 |
|---|---|---|
| Aloe Vera Extract 12 capsules taken daily for 30 days | Dietary supplement | Manapol |
| Control2 capsules taken daily for 30 days | Dietary supplement | Placebo |
| Aloe Vera Extract 22 capsules taken daily for 30 days | Dietary supplement | Dalton Max |
Primary outcome
White blood cell characterization
Time frame: baseline
A blood sample will be used to characterize the white blood cell population (cell count and distribution)
White blood cell characterization
Time frame: on day 30 of treatment
A blood sample will be used to characterize the white blood cell population (cell count and distribution)
Cytokine Panel for plasma
Time frame: baseline
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma
Cytokine Panel for plasma
Time frame: on day 30 of treatment
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma
Cytokine Panel on LPS stimulated whole blood
Time frame: baseline
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified on whole blood treated with LPS
Cytokine Panel on LPS stimulated whole blood
Time frame: on day 30 of treatment
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified on whole blood treated with LPS
Glucose
Time frame: baseline
Glucose levels in blood will be measured
Glucose
Time frame: on day 30 of treatment
Glucose levels in blood will be measured
Insulin
Time frame: baseline
Insulin levels in a blood sample will be measured
Insulin
Time frame: on day 30 of treatment
Insulin levels in a blood sample will be measured
Lipid peroxidation
Time frame: baseline
Lipid peroxiation in a blood sample will be quantified
Lipid peroxidation
Time frame: on day 30 of treatment
Lipid peroxiation in a blood sample will be quantified
Advanced oxidation protein products
Time frame: baseline
Advanced oxidation protein products in a blood sample will be quantified
Advanced oxidation protein products
Time frame: on day 30 of treatment
Advanced oxidation protein products in a blood sample will be quantified
Blood antioxidant capacity
Time frame: baseline
Blood antioxidant capacity will be quantified from a blood sample
Blood antioxidant capacity
Time frame: on day 30 of treatment
Blood antioxidant capacity will be quantified from a blood sample
Self-reported assessment of fatigue & associated variables
Time frame: baseline
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Self-reported assessment of fatigue & associated variables
Time frame: Week 1 of treatment
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Self-reported assessment of fatigue & associated variables
Time frame: Week 2 of treatment
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Self-reported assessment of fatigue & associated variables
Time frame: Week 3 of treatment
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Self-reported assessment of fatigue & associated variables
Time frame: Week 4 of treatment
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Subjects' perceived digestive/bowel health
Time frame: baseline
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Subjects' perceived digestive/bowel health
Time frame: Week 1 of treatment
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Subjects' perceived digestive/bowel health
Time frame: Week 2 of treatment
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Subjects' perceived digestive/bowel health
Time frame: Week 3 of treatment
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Subjects' perceived digestive/bowel health
Time frame: Week 4 of treatment
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Microbiome analysis
Time frame: baseline
Subjects will submit a stool sample kit for microbiome analysis
Microbiome analysis
Time frame: on Day 30 of treatment
Subjects will submit a stool sample kit for microbiome analysis
6 secondary outcomes
Food Logs
Time frame: baseline
Food Logs
Time frame: on Day 30 of treatment
Resting Blood Pressure
Time frame: baseline
Resting Blood Pressure
Time frame: on Day 30 of treatment
Resting Heart Rate
Time frame: baseline
Resting Heart Rate
Time frame: on day 30 of treatment
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 26 Sep 2023.
- 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.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aloe Vera Extract 1 and Aloe Vera Extract 2 in people with Microbiome and Immune Function, run by University of Memphis 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 9 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 26 Sep 2023. 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.
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?
White blood cell characterization (time frame: baseline). The study lists 28 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 26 Sep 2023.