Immune MarkersNCT04441840
Immune and Recovery Modulating Impact of Probiotic Supplementation After Intense Resistance Exercise
A study testing Active Probiotic Culture and Inactive Probiotic Culture in people with Immune Markers and Complete Blood Count (CBC) With Platelet Differentials, run by Lindenwood University at 1 site in United States.
Trial summary
This study proposal seeks to examine the efficacy of probiotic supplementation at mitigating changes in immune function and recovery after completion of intense, stressful exercise while also allowing for a better understanding of its ability to promote recovery and maintenance of physical performance. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Immune Markers, Complete Blood Count (CBC) With Platelet Differentials, Muscle Damage
- What is being tested?
- Active Probiotic Culture and Inactive Probiotic Culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 1 Aug 2021
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Free from any disorders or diseases as stated on health history form
- Between the ages of 18 - 55 years of age
Who cannot join
- Currently being treated for or are diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2 and body fat greater than 30%), immune, autoimmune, hematological, neurological or endocrinological disorder or disease unless the scenario is viewed to not be a contraindication by the clinical coordinator of the study protocol. Individuals who are currently prescribed a hypertensive or cholesterol-lowering medication will be allowed entry into the study with clearance from clinical coordinator or their personal physician.
- Female
- An individual who is less than 18 and greater than 55 years of age will be excluded.
- Participants younger than 18 are excluded due to necessity of parental consent.
- Participants greater than 55 years old lie outside of the target demographic for the current study.
- Considered to be sedentary, defined as getting less than 30 minutes of moderate intensity physical activity for most days of the week.
Show all 10Show fewer
- Currently not resistance training at least 2 days per week for the past 30 days
- Currently smoking or have quit smoking within the past 6 months
- Currently taking a probiotic. Individuals who currently report as taking a probiotic will be allowed entry into study protocol if a wash-out period of 30 days is observed.)
- Currently consuming any form of dietary supplements that are viewed by study investigators to confound the outcomes of the study protocol (i.e., creatine, beta-alanine, essential amino acids, beta-hydroxy-beta-methylbutyrate (HMB), branched-chain amino acids, or any pre-workout that contain combinations of these ingredients). Individuals who currently report as taking any of these supplements will be allowed entry into study protocol if a wash-out period of 30 days is observed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lindenwood University
Saint Charles, Missouri, 63301
About this study
This study proposal seeks to examine the efficacy of probiotic supplementation at mitigating changes in immune function and recovery after completion of intense, stressful exercise while also allowing for a better understanding of its ability to promote recovery and maintenance of physical performance.
Read the detailed description
Study Visit 1 - Familiarization:
During the familiarization visit, participants will first read and sign an IRB-approved informed consent document and complete a short form of the International Physical Activity Questionnaire (IPAQ). Participants will then have their height, weight, and body composition determined using Dual-Energy X-ray Absorptiometry (DEXA) (Hologic Discovery A). To standardize body composition assessment, participants will be required to observe an 8-hour fast and maintain a well-hydrated state. Each participant will provide a urine sample to confirm a hydrated stated through determination of a urine specific gravity values greater 1.020. Participants will then complete a peak oxygen consumption test (VO2Peak) using indirect calorimetry on a ParvoMedics TrueOne (Sandy, UT) metabolic cart interfaced to a motorized cycle ergometer (Lode Corival). The peak oxygen consumption test protocol will require each study participants to start at 100 watts before progressively increasing by 1 watt every two seconds. To determine whether maximal effort occurred a respiratory exchange ratio of >1.00 must be achieved.
Following the peak oxygen consumption assessment, participants will perform practice repetitions of all performance tests (force plate vertical jumps, isometric mid-thigh pulls, Biodex isometric and isokinetic knee extensor testing) as well as the exercises that will be performed during Visit 3 (leg press, hex bar deadlift, and drop jump).
Study Visit 2 - Pre-Supplementation Baseline Testing:
Study participants will be asked to complete a 24-hour food recall between each testing condition and will be asked to replicate their diet prior to this visit for all subsequent visits. Upon arrival, participants will first have their blood drawn from a forearm vein before completing a perceived soreness, pressure-pain threshold, and recovery assessment. Prior to testing, participants will complete the same standardized warm-up consisting of 5 minutes of light cycling, 10 body weight squats, 10 body weight walking lunges, 10 dynamic walking hamstring stretches (straight-leg march), and 10 dynamic walking quadriceps stretches. After the warm-up, participants will complete five countermovement jump squats on top of bilateral triaxial force plates (Hawkins Dynamics) interfaced to a personal computer to derive relevant force-time variables. Next, participants will complete two assessments of peak isometric force production. Using an electronic load cell with a 5,000-N capacity (Load Star load cells) connected to a computer, three 5-second maximal isometric mid-thigh pulls will be completed. Participants will then be outfitted on a Biodex isokinetic dynamometer where they will complete three maximal isometric knee extensions. Following the isometric knee extensor testing, participants will complete a 50-repetition test of concentric-only repetitions to assess changes in force production, torque, and rates of fatigue development. After the baseline performance testing, participants will have their leg press and hex bar deadlift one-repetition maximum (1RM) determined.
*Supplementation (14 days, described below) followed by exercise trial.*
Study Visit 3 (Post-Supplementation Testing, Exercise Trial):
Upon arrival, study participants will be asked to complete a 24-hour food recall and between each testing condition, study participants will be asked to replicate their diet. Upon arrival, participants will first have their blood drawn from a forearm vein before completing perceived soreness, pressure-pain threshold, and recovery assessments. Prior to testing, participants will complete the same standardized warm-up consisting of 5 minutes of light cycling, 10 body weight squats, 10 body weight walking lunges, 10 dynamic walking hamstring stretches (straight-leg march), and 10 dynamic walking quadriceps stretches. After the warm-up, participants will complete five countermovement jump squats on top of bilateral triaxial force plates (Hawkins Dynamics) interfaced to a personal computer to derive relevant force-time variables. Using an electronic load cell with a 5,000-N capacity (Load Star load cells) connected to a computer, three 5-second maximal isometric mid-thigh pulls will be completed. Participants will then be positioned on a Biodex isokinetic dynamometer where they will complete three maximal isometric knee extensions. Lastly, participants will complete a 50-repetition test of concentric-only repetitions to assess changes in force production, torque, and rates of fatigue development. Following the completion of these tests, participants will perform an exercise trial according to the methods described below. Following completion of the exercise trial, participants will undergo the previous testing battery (blood sample, perceived soreness, pressure-pain threshold assessment, recovery assessment, countermovement vertical jumps, isometric mid-thigh pulls, Biodex isometric and isokinetic testing) at five time points: immediately after exercise, 30 minutes post-exercise, 1 hour, 2 hours, and 5 hours post-exercise.
Study Visits 4 - 6: Post-Exercise Performance In an identical fashion, with the exception of 1RM assessment, study visits 4, 5, and 6 will be completed 24, 48, and 72 hours, respectively, after completion of the exercise bout. Briefly, study participants will return to the laboratory after an overnight fast (10 hours). Participants will bring in the completed 24-hour dietary recall, donate venous blood samples, assess their soreness, pressure-pain threshold, and recovery, complete the warm-up, perform five countermovement jumps, assess peak isometric force production, and complete a 50-repetition muscle fatigue test during each visit.
- Conditions
- Immune Markers, Complete Blood Count (CBC) With Platelet Differentials, Muscle Damage, Muscular Force Production, Countermovement Jump, Muscular Fatigue
- Being tested
- Active Probiotic Culture, Inactive Probiotic Culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Probiotic CultureDietary supplement
Both conditions matched in appearance and serving size
Inactive Probiotic CultureDietary supplement
Also called StaImune
Both conditions matched in appearance and serving size
| Study group | Role | What they receive |
|---|---|---|
| Active Probiotic Culture | Active comparator | Active culture of Bacillus Coagulans Dose: 1 x 10^9 colony forming units (CFU) Receives: Dietary Supplement: Active Probiotic Culture |
| Inactive Probiotic Culture | Active comparator | Inactive culture of Bacillus Coagulans (GBI-30, 6086) - Marked as "StaImune" Dose: 1 x 10^9 colony forming units (CFU) Receives: Dietary Supplement: Inactive Probiotic Culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Markers
C-reactive protein [milligrams per liter (mg/L)]
Measured: Three weeks
Complete blood count
White blood cell and platelet count [Thousand per microliter (Thousand/uL)]
Measured: Three weeks
Markers of muscle damage
Creatine kinase [Units per liter (U/L)]
Measured: Three weeks
Force production assessment
Maximal voluntary isometric contraction (knee extension) [pounds (lb)]
Measured: Three weeks
Force production assessment
Isometric mid-thigh pull [pounds (lb)]
Measured: Three weeks
Countermovement Jump
peak force [Newtons (N)]
Measured: Three weeks
Countermovement Jump
eccentric force [Newtons (N)]
Measured: Three weeks
Countermovement Jump
eccentric rate of force development [Newtons (N)]
Measured: Three weeks
Countermovement Jump
reactive strength index
Measured: Three weeks
Dynamic muscular fatigue
Biodex 50-repetition test [Percent fatigue rate]
Measured: Three weeks
Perceived soreness
Soreness questionnaire (0 - 10) 0 is low, 10 is high
Measured: Three weeks
Perceived soreness
pain-pressure threshold via algometer [Newtons (N)]
Measured: Three weeks
Immune Marker
Interleukin-6, Tumor necrosis factor-alpha, Monocyte chemoattractant protein 1 [picograms per milliliter (pg/mL)]
Measured: Three weeks
Markers of muscle damage
Myoglobin [nanogram per milliliter (ng/mL)].
Measured: Three weeks
Complete blood count (CBC)
Red blood cell count [Millions per microliter (million/uL)]
Measured: Three weeks
Complete blood count (CBC)
Hemoglobin and Mean corpuscular hemoglobin concentration (MCHC) [grams per deciliter (g/dL)]
Measured: Three weeks
Complete blood count (CBC)
Hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils,Red cell distribution width (RDW) [Percentage (%)]
Measured: Three weeks
Complete blood count (CBC)
Mean corpuscular volume (MCV) and Mean platelet volume (MPV) [Femtoliters (fL)]
Measured: Three weeks
Complete blood count (CBC)
Mean corpuscular hemoglobin (MCH) [Picograms (pg)]
Measured: Three weeks
Complete blood count (CBC)
Absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils [cells per microliter (cells/uL)]
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start16 Apr 2019
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune MarkersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad Kerksick, PhD, Principal investigator, Laboratory Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441840
- Sponsor's protocol ID
- IRB-19-161
- Status last verified
- Apr 2022
- First submitted
- 12 Jun 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All approved unidentified study data inside the laboratory will be saved within a research repository bank for future research questions. Otherwise, participant data will be destroyed after three years of study completion to maintain Institutional Review Board (IRB) compliance
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune and Recovery Modulating Impact of Probiotic Supplementation After Intense Resistance Exercise
- ClinicalTrials.gov ID
- NCT04441840
- Acronym / sponsor ID
- IRB-19-161
- Conditions
- Immune Markers, Complete Blood Count (CBC) With Platelet Differentials, Muscle Damage, Muscular Force Production, Countermovement Jump, Muscular Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 22 Jun 2020 (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.
This study proposal seeks to examine the efficacy of probiotic supplementation at mitigating changes in immune function and recovery after completion of intense, stressful exercise while also allowing for a better understanding of its ability to promote recovery and maintenance of physical performance.
Detailed description
Study Visit 1 - Familiarization:
During the familiarization visit, participants will first read and sign an IRB-approved informed consent document and complete a short form of the International Physical Activity Questionnaire (IPAQ). Participants will then have their height, weight, and body composition determined using Dual-Energy X-ray Absorptiometry (DEXA) (Hologic Discovery A). To standardize body composition assessment, participants will be required to observe an 8-hour fast and maintain a well-hydrated state. Each participant will provide a urine sample to confirm a hydrated stated through determination of a urine specific gravity values greater 1.020. Participants will then complete a peak oxygen consumption test (VO2Peak) using indirect calorimetry on a ParvoMedics TrueOne (Sandy, UT) metabolic cart interfaced to a motorized cycle ergometer (Lode Corival). The peak oxygen consumption test protocol will require each study participants to start at 100 watts before progressively increasing by 1 watt every two seconds. To determine whether maximal effort occurred a respiratory exchange ratio of >1.00 must be achieved.
Following the peak oxygen consumption assessment, participants will perform practice repetitions of all performance tests (force plate vertical jumps, isometric mid-thigh pulls, Biodex isometric and isokinetic knee extensor testing) as well as the exercises that will be performed during Visit 3 (leg press, hex bar deadlift, and drop jump).
Study Visit 2 - Pre-Supplementation Baseline Testing:
Study participants will be asked to complete a 24-hour food recall between each testing condition and will be asked to replicate their diet prior to this visit for all subsequent visits. Upon arrival, participants will first have their blood drawn from a forearm vein before completing a perceived soreness, pressure-pain threshold, and recovery assessment. Prior to testing, participants will complete the same standardized warm-up consisting of 5 minutes of light cycling, 10 body weight squats, 10 body weight walking lunges, 10 dynamic walking hamstring stretches (straight-leg march), and 10 dynamic walking quadriceps stretches. After the warm-up, participants will complete five countermovement jump squats on top of bilateral triaxial force plates (Hawkins Dynamics) interfaced to a personal computer to derive relevant force-time variables. Next, participants will complete two assessments of peak isometric force production. Using an electronic load cell with a 5,000-N capacity (Load Star load cells) connected to a computer, three 5-second maximal isometric mid-thigh pulls will be completed. Participants will then be outfitted on a Biodex isokinetic dynamometer where they will complete three maximal isometric knee extensions. Following the isometric knee extensor testing, participants will complete a 50-repetition test of concentric-only repetitions to assess changes in force production, torque, and rates of fatigue development. After the baseline performance testing, participants will have their leg press and hex bar deadlift one-repetition maximum (1RM) determined.
*Supplementation (14 days, described below) followed by exercise trial.*
Study Visit 3 (Post-Supplementation Testing, Exercise Trial):
Upon arrival, study participants will be asked to complete a 24-hour food recall and between each testing condition, study participants will be asked to replicate their diet. Upon arrival, participants will first have their blood drawn from a forearm vein before completing perceived soreness, pressure-pain threshold, and recovery assessments. Prior to testing, participants will complete the same standardized warm-up consisting of 5 minutes of light cycling, 10 body weight squats, 10 body weight walking lunges, 10 dynamic walking hamstring stretches (straight-leg march), and 10 dynamic walking quadriceps stretches. After the warm-up, participants will complete five countermovement jump squats on top of bilateral triaxial force plates (Hawkins Dynamics) interfaced to a personal computer to derive relevant force-time variables. Using an electronic load cell with a 5,000-N capacity (Load Star load cells) connected to a computer, three 5-second maximal isometric mid-thigh pulls will be completed. Participants will then be positioned on a Biodex isokinetic dynamometer where they will complete three maximal isometric knee extensions. Lastly, participants will complete a 50-repetition test of concentric-only repetitions to assess changes in force production, torque, and rates of fatigue development. Following the completion of these tests, participants will perform an exercise trial according to the methods described below. Following completion of the exercise trial, participants will undergo the previous testing battery (blood sample, perceived soreness, pressure-pain threshold assessment, recovery assessment, countermovement vertical jumps, isometric mid-thigh pulls, Biodex isometric and isokinetic testing) at five time points: immediately after exercise, 30 minutes post-exercise, 1 hour, 2 hours, and 5 hours post-exercise.
Study Visits 4 - 6: Post-Exercise Performance In an identical fashion, with the exception of 1RM assessment, study visits 4, 5, and 6 will be completed 24, 48, and 72 hours, respectively, after completion of the exercise bout. Briefly, study participants will return to the laboratory after an overnight fast (10 hours). Participants will bring in the completed 24-hour dietary recall, donate venous blood samples, assess their soreness, pressure-pain threshold, and recovery, complete the warm-up, perform five countermovement jumps, assess peak isometric force production, and complete a 50-repetition muscle fatigue test during each visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Probiotic Culture | Active comparator | Dietary Supplement: Active Probiotic CultureActive culture of Bacillus Coagulans Dose: 1 x 10^9 colony forming units (CFU) |
| Inactive Probiotic Culture | Active comparator | Dietary Supplement: Inactive Probiotic CultureInactive culture of Bacillus Coagulans (GBI-30, 6086) - Marked as "StaImune" Dose: 1 x 10^9 colony forming units (CFU) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- Free from any disorders or diseases as stated on health history form
- Between the ages of 18 - 55 years of age
Key exclusion criteria (10 listed)
- Currently being treated for or are diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2 and body fat greater than 30%), immune, autoimmune, hematological, neurological or endocrinological disorder or disease unless the scenario is viewed to not be a contraindication by the clinical coordinator of the study protocol. Individuals who are currently prescribed a hypertensive or cholesterol-lowering medication will be allowed entry into the study with clearance from clinical coordinator or their personal physician.
- Female
- An individual who is less than 18 and greater than 55 years of age will be excluded.
- Participants younger than 18 are excluded due to necessity of parental consent.
- Participants greater than 55 years old lie outside of the target demographic for the current study.
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 |
|---|---|---|
| Active Probiotic CultureBoth conditions matched in appearance and serving size | Dietary supplement | Active Probiotic Culture |
| Inactive Probiotic CultureAlso: StaImuneBoth conditions matched in appearance and serving size | Dietary supplement | Inactive Probiotic Culture |
Primary outcome
Immune Markers
Time frame: Three weeks
C-reactive protein [milligrams per liter (mg/L)]
Complete blood count
Time frame: Three weeks
White blood cell and platelet count [Thousand per microliter (Thousand/uL)]
Markers of muscle damage
Time frame: Three weeks
Creatine kinase [Units per liter (U/L)]
Force production assessment
Time frame: Three weeks
Maximal voluntary isometric contraction (knee extension) [pounds (lb)]
Force production assessment
Time frame: Three weeks
Isometric mid-thigh pull [pounds (lb)]
Countermovement Jump
Time frame: Three weeks
peak force [Newtons (N)]
Countermovement Jump
Time frame: Three weeks
eccentric force [Newtons (N)]
Countermovement Jump
Time frame: Three weeks
eccentric rate of force development [Newtons (N)]
Countermovement Jump
Time frame: Three weeks
reactive strength index
Dynamic muscular fatigue
Time frame: Three weeks
Biodex 50-repetition test [Percent fatigue rate]
Perceived soreness
Time frame: Three weeks
Soreness questionnaire (0 - 10) 0 is low, 10 is high
Perceived soreness
Time frame: Three weeks
pain-pressure threshold via algometer [Newtons (N)]
Immune Marker
Time frame: Three weeks
Interleukin-6, Tumor necrosis factor-alpha, Monocyte chemoattractant protein 1 [picograms per milliliter (pg/mL)]
Markers of muscle damage
Time frame: Three weeks
Myoglobin [nanogram per milliliter (ng/mL)].
Complete blood count (CBC)
Time frame: Three weeks
Red blood cell count [Millions per microliter (million/uL)]
Complete blood count (CBC)
Time frame: Three weeks
Hemoglobin and Mean corpuscular hemoglobin concentration (MCHC) [grams per deciliter (g/dL)]
Complete blood count (CBC)
Time frame: Three weeks
Hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils,Red cell distribution width (RDW) [Percentage (%)]
Complete blood count (CBC)
Time frame: Three weeks
Mean corpuscular volume (MCV) and Mean platelet volume (MPV) [Femtoliters (fL)]
Complete blood count (CBC)
Time frame: Three weeks
Mean corpuscular hemoglobin (MCH) [Picograms (pg)]
Complete blood count (CBC)
Time frame: Three weeks
Absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils [cells per microliter (cells/uL)]
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 5 Apr 2022.
- Individual participant dataSharing planned: No. All approved unidentified study data inside the laboratory will be saved within a research repository bank for future research questions. Otherwise, participant data will be destroyed after three years of study completion to maintain Institutional Review Board (IRB) compliance
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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.
Chad Kerksick, PhD principal investigator
Laboratory Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Probiotic Culture and Inactive Probiotic Culture in people with Immune Markers and Complete Blood Count (CBC) With Platelet Differentials, run by Lindenwood University 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 10 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 5 Apr 2022. 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.
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?
Immune Markers (time frame: Three weeks). The study lists 20 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 5 Apr 2022.