Cognitive Ability, GeneralNCT07565883
Adolescent Probiotics in Stressed Adolescents
A study testing Probiotics in people with Cognitive Ability, General and Immune System Function, run by University of Utah at 2 sites in United States.
Trial summary
Stress is a normal human reaction to changes surrounding our reality, resulting in physical, emotional, and intellectual responses. Children and adolescents often experience high levels of stress. Age and gender may affect a child's ability to manage stress. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Ability, General, Immune System Function, Emotions
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 May 2022to 25 Nov 2024
- 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 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants: Males and females
- Participants: 12-20 years old
- Participants with sustained moderate stress levels as determined by the Perceived Stress Scale (PSS), average score 14-26
- Participants with BMI percentile >5% and <97%
- Participants receiving or not receiving cognitive behavioral therapy.
Who cannot join
- Participants less than 12 years of age or over 20 years of age at enrollment.
- Participants with PSS average scores less than 14 and more than 26.
- Participants with BMI percentile <5% or >97%
- Participants receiving selective serotonin reuptake inhibitors (SSRIs).
- Participants who take any nutraceutical having an effect on stress anxiety within 1 month before subject screening.
- Participants who are female and report being pregnant.
Show all 9Show fewer
- Participants receiving immunosuppressive therapy.
- Participants having immune deficiencies.
- Adverse reactions to any probiotic.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Division Clinical Pharmacology, SOM, University of Utah
Salt Lake City, Utah, 84108
University of Utah, Pediatrics and Primary Childrens Hospital
Salt Lake City, Utah, 84108
About this study
Official title: Analysis of Brain and Immune Functions in Adolescents Using Probiotics
Stress is a normal human reaction to changes surrounding our reality, resulting in physical, emotional, and intellectual responses. Children and adolescents often experience high levels of stress. Age and gender may affect a child's ability to manage stress. Children and adolescents experiencing stress could be at an increased risk of poor cognitive, social, and emotional functioning. Probiotics are living microorganisms that could positively affect microbiota, support functions of numerous organs and systems, and overall human health. Most probiotics belong to the Lactobacillus genus. Probiotics can potentially support mental health, psychological function, and immune defenses.
The purpose of this exploratory clinical trial is to investigate whether supplementation of the diets of adolescents experiencing moderate stress with the probiotic dietary supplement a blend of two probiotic Lactobacillus plantarum and one Lactobacillus brevis strains will support their emotions (e.g., psychological well-being, social relationship, stress levels, and self-efficacy), cognitive (e.g., attention, episodic and working memory) and immune functions (e.g., salivary IgA and salivary cytokine productions). This study is intended only to evaluate the dietary supplement's effect on the body's structure or function. Our investigation is not intended to mitigate, cure, treat, or prevent disease.
Read the detailed description
Children and adolescents often experience high levels of stress. Age and gender may affect the ability of a child to manage stress. Children and adolescents experiencing stress could be at an increased risk of poor cognitive, social, and emotional functioning, and may have altered immune responses due to stress.
Probiotics are living microorganisms that could positively affect microbiota, support functions of numerous organs and systems, and overall human health. Most probiotics belong to the Lactobacillus genus. It has been suggested that probiotics potentially can support mental health, psychological function, and immune defenses. Recent studies confirmed that the use of pre- and probiotics improves the psychological scores of people predisposed to mood disorders. A supplementation of the diet of healthy volunteers with a probiotic for four weeks resulted in a significant reduction of subjects' rumination and aggressive thoughts. Lactobacillus plantarum DR7 reduces signs of stress and improves immune functions in adults. Consumption of this probiotic for 12 weeks reduced signs of stress and improved the psychological scores of participants. The levels of inflammatory cytokines are higher in people with anxiety. The use of Lactobacillus plantarum DR7 reduced levels of inflammatory cytokines (e.g., IFNgamma).
The purpose of this exploratory clinical trial is to investigate whether supplementation of the diets of adolescents experiencing moderate stress with the probiotic dietary supplement a blend of two Lactobacillus plantarum and one Lactobacillus brevis probiotic strains will support participants emotions (e.g., psychological well-being, social relationship, stress levels, and self-efficacy), cognitive (e.g., attention, episodic and working memory) and immune functions (e.g., salivary IgA and salivary cytokine productions). This study is intended only to evaluate the dietary supplement's effect on the body's structure or function. Our investigation is not intended to mitigate, cure, treat, or prevent disease.
The study will be an exploratory single-blind, randomized clinical trial of a dietary supplement containing 2 billion CFU of a probiotic strains: two Lactobacillus plantarum and one Lactobacillus brevis probiotic strains. Stains are present in the mixture at a ratio of 2:1:1. All strains are currently used as dietary supplements in the United States.
Participants for this trial will be selected based on the following criteria: participants age 12-20 years old, BMI percentile >5% and <97% with moderate stress levels (Perceived Stress Scale (PPS) score 14-26), receiving or not receiving cognitive behavioral therapy, and not on selective serotonin reuptake inhibitors (SSRIs). Investigators planned to enroll 120 participants, with 60 participants in the dietary supplement (Probiotics) arm. The probiotics arm will receive caps with the probiotic blend, and control participants will receive caps containing a placebo for the same period. Participants will be asked to consume the caps with dinner meals for 12 consecutive weeks. If the probiotic was not taken during dinner, then it should be taken within 2 hours after dinner or with the next meal.
The investigators have used the NIH Toolbox for Assessment of Neurological and Behavioral Function, which has been designed for scientists interested in evaluating the emotional and cognitive functions of clinical study participants. NIH Toolbox was validated across the entire age range.
The Investigators used the following NIH Toolbox domains to assess participants' progress:
- Emotion Domain consisting of instruments evaluating psychological well-being, social relationships, stress, self-efficacy, and negative affect. Additionally, we used PROMIS CAT Emotional Support, Psychological Stress Experiences, and Sleep Disturbance tests.
- Cognition Domain consisting of attention, episodic and working memories, language, and processing speed.
Biomarkers of immune function were investigated: salivary cytokine levels IL1beta, IL6, IL8, IFNgamma, and TNFα, and IL10, and immunoglobulin - secretory IgA.
- Salivary AM and PM cortisol levels were measured All biomarkers were measured at baseline, 8 weeks, and 12 weeks of probiotics/placebo use by participants.
- Conditions
- Cognitive Ability, General, Immune System Function, Emotions
- Being tested
- Probiotics, placebo
- Keywords
- adolescent, moderate stress, probiotics, cognition, emotional status, immune functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
The participants started taking capsules the day after the first visit, after collecting the AM saliva sample, and continued taking them daily (preferably with a dinner meal) for 12 consecutive weeks. If the probiotic was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal
placeboDietary supplement
The participants started taking placebo capsules the day after the first visit, after collecting the AM saliva sample, and continued taking them daily (preferably with a dinner meal) for 12 consecutive weeks. If the probiotic was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal
| Study group | Role | What they receive |
|---|---|---|
| Probiotics supplement | Experimental | Participants received the probiotics blend containing two Lactobacillus plantarum and one Lactobacillus brevis strains for 12 weeks. The probiotic blend contained 2 billion CFU bacteria. Stains are present in the mixture at a ratio of 2:1:1. Participants were taking them daily with meals, (preferably with a dinner meal) for 12 consecutive weeks. If the probiotic was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal Receives: Dietary Supplement: Probiotics |
| Placebo cohort | Placebo comparator | The participants started taking placebo capsules the day after the first visit, after collecting the AM saliva sample, and continued taking them daily (preferably with a dinner meal) for 12 consecutive weeks. If the capsule was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotinal status and cognitive functions of participants
The NIH Toolbox was used to assess participants' emotional and cognitive functions. The Emotion Domain consisted of instruments evaluating psychological well-being, social relationships, stress, self-efficacy, and negative affect. Additionally, PROMIS CAT Emotional Support, Psychological Stress Experiences, and Sleep Disturbance tests were administered. The Cognition Domain test consisted of attention, episodic and working memories, language, and processing speed.
Measured: From enrollment (week 0), 8 weeks and 12 weeks (end of study)
Secondary outcomes (2)
Changes in the immune functions of participants
Biomarkers of immune function were analyzed.
- Salivary cytokine levels: IL1beta, IL6, IL8, IFNgamma, and TNFα, and Th2 (IL10) cytokines,
- Salivary immunoglobulin sIgA. Collected samples were stored in a -80°C freezer until shipped for analysis to Salimetrics. Saliva samples were analyzed in duplicates by Salimetrics.
Measured: From enrollment (week 0), 8 weeks and 12 weeks (end of study)
Evaluation of AM and PM cortisol levels
Salivary samples for cortisol analysis were collected by participants 1-2 days before the in-person appointment and stored in the household freezers. AM samples were collected before 8 AM, and PM samples were collected 2 hours before bedtime. Levels of cortisol were analyzed by Salimetrics
Measured: From enrollment (week 0), 8 weeks and 12 weeks (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start3 May 2022
- Primary completion22 Jul 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive Ability, GeneralStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Kaneka Americas Holding Inc.
- Responsible party
- Principal investigator, Elena Enioutina, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565883
- Sponsor's protocol ID
- 20211028
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Steenbergen, L., Sellaro, R., van Hemert, S., Bosch, J. A., and Colzato, L. S. (2015) A randomized controlled trial to test the effect of multispecies probiotics on cognitive reactivity to sad mood. Brain Behav Immun 48, 258-264 2. Chong, H. X., Yusoff, N. A. A., Hor, Y. Y., Lew, L. C., Jaafar, M. H., Choi, S. B., Yusoff, M. S. B., Wahid, N., Abdullah, M., Zakaria, N., Ong, K. L., Park, Y. H., and Liong, M. T. (2019) Lactobacillus plantarum DR7 alleviates stress and anxiety in adults: a randomised, double-blind, placebo-controlled study. Benef Microbes 10, 355-373 3. Quagliato, L. A., and Nardi, A. E. (2018) Cytokine alterations in panic disorder: A systematic review. J Affect Disord 228, 91-96
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Brain and Immune Functions in Adolescents Using Probiotics
- ClinicalTrials.gov ID
- NCT07565883
- Acronym / sponsor ID
- 20211028
- Conditions
- Cognitive Ability, General, Immune System Function, Emotions
- Keywords
- adolescent, moderate stress, probiotics, cognition, emotional status, immune functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Kaneka Americas Holding Inc.
- Study start
- 3 May 2022 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 4 May 2026 (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.
Stress is a normal human reaction to changes surrounding our reality, resulting in physical, emotional, and intellectual responses. Children and adolescents often experience high levels of stress. Age and gender may affect a child's ability to manage stress. Children and adolescents experiencing stress could be at an increased risk of poor cognitive, social, and emotional functioning. Probiotics are living microorganisms that could positively affect microbiota, support functions of numerous organs and systems, and overall human health. Most probiotics belong to the Lactobacillus genus. Probiotics can potentially support mental health, psychological function, and immune defenses.
The purpose of this exploratory clinical trial is to investigate whether supplementation of the diets of adolescents experiencing moderate stress with the probiotic dietary supplement a blend of two probiotic Lactobacillus plantarum and one Lactobacillus brevis strains will support their emotions (e.g., psychological well-being, social relationship, stress levels, and self-efficacy), cognitive (e.g., attention, episodic and working memory) and immune functions (e.g., salivary IgA and salivary cytokine productions). This study is intended only to evaluate the dietary supplement's effect on the body's structure or function. Our investigation is not intended to mitigate, cure, treat, or prevent disease.
Detailed description
Children and adolescents often experience high levels of stress. Age and gender may affect the ability of a child to manage stress. Children and adolescents experiencing stress could be at an increased risk of poor cognitive, social, and emotional functioning, and may have altered immune responses due to stress.
Probiotics are living microorganisms that could positively affect microbiota, support functions of numerous organs and systems, and overall human health. Most probiotics belong to the Lactobacillus genus. It has been suggested that probiotics potentially can support mental health, psychological function, and immune defenses. Recent studies confirmed that the use of pre- and probiotics improves the psychological scores of people predisposed to mood disorders. A supplementation of the diet of healthy volunteers with a probiotic for four weeks resulted in a significant reduction of subjects' rumination and aggressive thoughts. Lactobacillus plantarum DR7 reduces signs of stress and improves immune functions in adults. Consumption of this probiotic for 12 weeks reduced signs of stress and improved the psychological scores of participants. The levels of inflammatory cytokines are higher in people with anxiety. The use of Lactobacillus plantarum DR7 reduced levels of inflammatory cytokines (e.g., IFNgamma).
The purpose of this exploratory clinical trial is to investigate whether supplementation of the diets of adolescents experiencing moderate stress with the probiotic dietary supplement a blend of two Lactobacillus plantarum and one Lactobacillus brevis probiotic strains will support participants emotions (e.g., psychological well-being, social relationship, stress levels, and self-efficacy), cognitive (e.g., attention, episodic and working memory) and immune functions (e.g., salivary IgA and salivary cytokine productions). This study is intended only to evaluate the dietary supplement's effect on the body's structure or function. Our investigation is not intended to mitigate, cure, treat, or prevent disease.
The study will be an exploratory single-blind, randomized clinical trial of a dietary supplement containing 2 billion CFU of a probiotic strains: two Lactobacillus plantarum and one Lactobacillus brevis probiotic strains. Stains are present in the mixture at a ratio of 2:1:1. All strains are currently used as dietary supplements in the United States.
Participants for this trial will be selected based on the following criteria: participants age 12-20 years old, BMI percentile >5% and <97% with moderate stress levels (Perceived Stress Scale (PPS) score 14-26), receiving or not receiving cognitive behavioral therapy, and not on selective serotonin reuptake inhibitors (SSRIs). Investigators planned to enroll 120 participants, with 60 participants in the dietary supplement (Probiotics) arm. The probiotics arm will receive caps with the probiotic blend, and control participants will receive caps containing a placebo for the same period. Participants will be asked to consume the caps with dinner meals for 12 consecutive weeks. If the probiotic was not taken during dinner, then it should be taken within 2 hours after dinner or with the next meal.
The investigators have used the NIH Toolbox for Assessment of Neurological and Behavioral Function, which has been designed for scientists interested in evaluating the emotional and cognitive functions of clinical study participants. NIH Toolbox was validated across the entire age range.
The Investigators used the following NIH Toolbox domains to assess participants' progress:
- Emotion Domain consisting of instruments evaluating psychological well-being, social relationships, stress, self-efficacy, and negative affect. Additionally, we used PROMIS CAT Emotional Support, Psychological Stress Experiences, and Sleep Disturbance tests.
- Cognition Domain consisting of attention, episodic and working memories, language, and processing speed.
Biomarkers of immune function were investigated: salivary cytokine levels IL1beta, IL6, IL8, IFNgamma, and TNFα, and IL10, and immunoglobulin - secretory IgA.
- Salivary AM and PM cortisol levels were measured All biomarkers were measured at baseline, 8 weeks, and 12 weeks of probiotics/placebo use by participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics supplement | Experimental | Dietary Supplement: ProbioticsParticipants received the probiotics blend containing two Lactobacillus plantarum and one Lactobacillus brevis strains for 12 weeks. The probiotic blend contained 2 billion CFU bacteria. Stains are present in the mixture at a ratio of 2:1:1. Participants were taking them daily with meals, (preferably with a dinner meal) for 12 consecutive weeks. If the probiotic was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal |
| Placebo cohort | Placebo comparator | Dietary Supplement: placeboThe participants started taking placebo capsules the day after the first visit, after collecting the AM saliva sample, and continued taking them daily (preferably with a dinner meal) for 12 consecutive weeks. If the capsule was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Participants: Males and females
- Participants: 12-20 years old
- Participants with sustained moderate stress levels as determined by the Perceived Stress Scale (PSS), average score 14-26
- Participants with BMI percentile >5% and <97%
- Participants receiving or not receiving cognitive behavioral therapy.
Key exclusion criteria (9 listed)
- Participants less than 12 years of age or over 20 years of age at enrollment.
- Participants with PSS average scores less than 14 and more than 26.
- Participants with BMI percentile <5% or >97%
- Participants receiving selective serotonin reuptake inhibitors (SSRIs).
- Participants who take any nutraceutical having an effect on stress anxiety within 1 month before subject screening.
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 |
|---|---|---|
| ProbioticsThe participants started taking capsules the day after the first visit, after collecting the AM saliva sample, and continued taking them daily (preferably with a dinner meal) for 12 consecutive weeks. If the probiotic was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal | Dietary supplement | Probiotics supplement |
| placeboThe participants started taking placebo capsules the day after the first visit, after collecting the AM saliva sample, and continued taking them daily (preferably with a dinner meal) for 12 consecutive weeks. If the probiotic was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal | Dietary supplement | Placebo cohort |
Primary outcome
Emotinal status and cognitive functions of participants
Time frame: From enrollment (week 0), 8 weeks and 12 weeks (end of study)
The NIH Toolbox was used to assess participants' emotional and cognitive functions. The Emotion Domain consisted of instruments evaluating psychological well-being, social relationships, stress, self-efficacy, and negative affect. Additionally, PROMIS CAT Emotional Support, Psychological Stress Experiences, and Sleep Disturbance tests were administered. The Cognition Domain test consisted of attention, episodic and working memories, language, and processing speed.
2 secondary outcomes
Changes in the immune functions of participants
Time frame: From enrollment (week 0), 8 weeks and 12 weeks (end of study)
Evaluation of AM and PM cortisol levels
Time frame: From enrollment (week 0), 8 weeks and 12 weeks (end of study)
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 4 May 2026.
- Background1. Steenbergen, L., Sellaro, R., van Hemert, S., Bosch, J. A., and Colzato, L. S. (2015) A randomized controlled trial to test the effect of multispecies probiotics on cognitive reactivity to sad mood. Brain Behav Immun 48, 258-264 2. Chong, H. X., Yusoff, N. A. A., Hor, Y. Y., Lew, L. C., Jaafar, M. H., Choi, S. B., Yusoff, M. S. B., Wahid, N., Abdullah, M., Zakaria, N., Ong, K. L., Park, Y. H., and Liong, M. T. (2019) Lactobacillus plantarum DR7 alleviates stress and anxiety in adults: a randomised, double-blind, placebo-controlled study. Benef Microbes 10, 355-373 3. Quagliato, L. A., and Nardi, A. E. (2018) Cytokine alterations in panic disorder: A systematic review. J Affect Disord 228, 91-96
- Individual participant dataSharing planned: No
Related trials for Cognitive Ability, General
Not yet recruiting
Thrive at Home: A Virtual Reality Social Intervention for Older Adults
Mental Health (Depression), Mental Health and General Well-being
Not yet recruiting
EFFET - Study of Executive Functions Regarding the Usability and User Experience of Assistive Technologies Among the Elderly
Gerontology, Cognitive Ability General
RecruitingObservational study
Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective
Aphasia, Development, Human
RecruitingObservational study
Automated IADL Sensing to Refine Measurement of Older Adult Daily Activity
Cognitive Ability General, Functional Abilities
Recruiting
Effect of Sage Extract Supplementation on Cognitive Function in Middle-Aged Men and Women
Cognitive Ability, General
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Cognitive Ability, General and Immune System Function, run by University of Utah at 2 sites 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 5 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 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Emotinal status and cognitive functions of participants (time frame: From enrollment (week 0), 8 weeks and 12 weeks (end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07565883, which also lists 1 linked publication.
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 4 May 2026.