Parkinson Disease (PD)GBPDCNCT07567794
GBPDC: Gut-Brain in PD Consortium Master Protocol
An observational study of Parkinson Disease (PD) and PARKINSON DISEASE (Disorder), run by Duke University at 7 sites in United States.
Trial summary
The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease (PD), PARKINSON DISEASE (Disorder), Gut Microbiome
- How many people
- 250 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Jul 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients at the NIDDK designated Gastroenterology Neurology Research Centers
Who may be able to join
- Aged ≥21 years old and ≤80 years old
- Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria
- Adequate visual, hearing, cognitive, and physical ability
- Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. Because longitudinal participation is important to the scientific goals of the program, a "best estimate" of interest, commitment, and geographic feasibility for three years will be documented by the enrolling investigator after interview with the potential enrollee
- Aged ≥21 years old and ≤80 years old
- No known or diagnosed neurodegenerative disease
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- Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures
- Resides within the same household as person with PD
- Aged ≥21 years old and ≤80 years old
- Prodromal characteristics are defined by the MDS Research Criteria for PD and include either polysomnography (PSG)-confirmed rapid eye movement sleep behavior disorder (RBD) or possible RBD (questionnaire-based), with hyposmia as defined by the University of Pennsylvania Smell Identification Test (UPSIT) ≤ 15th percentile.
Who cannot join
- Diagnosis of secondary or atypical parkinsonism
- Laboratory Values:
- Hemoglobin (Hgb) <10
- Platelets <70,000
- Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) > 2 1/2 times upper limit of normal (ULN)
- Moderate or severe renal disease with an estimated glomerular filtration rate (eGFR) <60 mL/min/BSA [body surface area]) calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation, or moderate or severe hepatic impairment (alkaline phosphatase [ALP] >2.0 times the ULN and/or total bilirubin >2.0 times the ULN)
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- Significantly above the normal range for PT/INR/PTT
- Currently taking anticoagulants that are deemed exclusionary by the investigator for risk of bleeding with sigmoidoscopy procedure
- Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score <22
- Clinical or laboratory findings consistent with another primary neurodegenerative disease or cognitive disorder other than PD, including but not limited to, frontotemporal lobar disease, Huntington's disease, progressive supranuclear palsy, multisystem atrophy, Creutzfeld-Jakob- Disease, Down's syndrome, cortico-basal degeneration, dementia with Lewy Bodies, Alzheimer's disease, amyotrophic lateral sclerosis, seizure disorder, stroke, or other infectious, metabolic, or systemic disease affecting the central nervous system including, but not limited to, syphilis, present hypothyroidism, present or unaddressed/treated vitamin B12 deficiency, or other screening laboratory abnormalities
- Suicidality, defined as active suicidal thoughts or ideation within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide
- Has cancer or has had a malignant tumor within the past 5 years. (Participants with stable untreated prostate cancer or treated/removed cutaneous carcinomas are not excluded.)
- Any medical condition or systemic disease that, in the Investigator's opinion, may either put the participant at risk because of participation in the study, influence the results or proposed analyses, or impair the participant's ability to fully participate in the study
- Body mass index (BMI) >35 kg/m2 or body weight <50 kg
- Participant is currently pregnant, breastfeeding, and/or lactating
- History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)
- History of Covid 19 (SARS-CoV-2) infection within 6 weeks prior to screening.
- Participants with unresolved symptoms of Covid 19 infection or ongoing cognitive or other deficits attributable to post-Covid 19 that may affect participant safety or interfere with cognitive assessments based on the Investigator's clinical judgment
- Either ongoing or current participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken. Participation in other research studies (e.g., observational studies) may be acceptable throughout this study.
- History of GI surgery. (However, patients with appendicectomy, hemorrhoid surgery, and cholecystectomy will be eligible to participate).
- Regular use of medication that impacts the intestinal barrier (e.g., NSAID more than 3 times weekly)
- Has a history of Crohn's disease, ulcerative colitis, and/or other types of colitis (microscopic, lymphocytic, or collagenous colitis). Confirmed diagnosis of inflammatory bowel disease (IBD) and/or, active or uncontrolled IBD symptoms such as diarrhea, bleeding, or severe stomach pain. Treatment for IBD in the past 6 months with medicines such as steroids, biologics, or strong immune-suppressing drugs. Surgery to remove part of the bowel due to IBD. Other long-term gut diseases that cause inflammation, such as celiac disease.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Anna Borodianski, 617-724-0480, GIMotilityResearch@MGH.HARVARD.EDU
Aleksander Videnovic, MD
- Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Stephanie N Slan, MBA, ACRP-CP, slans@musc.edu
- Recruiting
Rush University
Chicago, Illinois, 60612
Michelle Villanueva, MS, 312-942-8927, michelle_villanueva@rush.edu
Ali Keshavarzian, MD
- Not yet recruiting
University of Chicago
Chicago, Illinois, 60637
Hanna Lancerio, 773-633-8412, hlancerio@bsd.uchicago.edu
Tao Xie, MD, PhD
- Not yet recruiting
Columbia University
New York, New York, 10027
Katharine Godfrey, kb3217@cumc.columbia.edu
Braden Kuo, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Kelly Feuerhak, BSN, RN, CCRP, 507-255-6802, rstgistudy@mayo.edu
Adil Bharucha, MBBS, MD
- Recruiting
Stanford University
Stanford, California, 94305
Marian Shahid-Besanti, MSc, 650-723-0060, gutbrainresearch@stanford.edu
Kathleen L Poston, MD, MS
About this study
Official title: Consortium for Gut-Brain Communication in Parkinson's Disease Master Protocol
The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study.
During this study, specific groups of participants, also known as "cohorts", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection.
Read more
Participants in this study will:
- meet with a medical provider
- answer questionnaires
- give samples of blood, stool, and saliva
- have X-rays taken while swallowing different foods (swallowing study)
- have X-rays taken to see how long it takes markers to move through their colon (colon transit study)
- have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining)
- have samples taken of their skin
- have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function.
Participation in the study will last up to 24 months (2 years).
Read the detailed description
The objectives of the master protocol are to establish a common platform that: (1) assures the collection, integration, and analysis of a set of uniformly collected data across all participating centers, and (2) follows the objective of the Gut-Brain Parkinson's Disease Consortium (GBPDC) with the goal "to enhance our understanding of the temporal onset of GI symptoms in PD and changes in gut-brain communication that can be used to leverage the potential role of the GI tract in the pathogenesis and progression of PD and to improve patient diagnosis, care, and outcomes."
Primary Objective
- To collect prospective cross-sectional and longitudinal participant biospecimens with temporally coordinated evaluations of GI and neurological symptoms and functions to better characterize the phenotype of people with PD versus those without.
Secondary Objectives
- To elucidate the biological processes and pathways relevant to the role of the GI tract in the pathogenesis and progression of PD.
- To characterize GI symptoms, pathology, and gut-brain communication in PD to detect early and longitudinal changes in gut function and activity that correspond to the development or progression of PD.
Exploratory Objectives
- To identify possible novel gut-based biomarkers (functional, molecular, etc.), diagnostic tools, and therapeutic targets.
- To investigate the impact of neuroimmune interactions and other pathways in the GI tract on gut-brain communication and PD risk.
In conjunction with clinical, social, and environmental characterization, biospecimen collection within the GBPDC master protocol will provide the opportunity to probe and characterize the pathophysiologic underpinnings of the gut-brain axis in PD, refine existing biomarker testing for PD, and identify new biomarkers that could allow early detection of PD or new targets for treatment.
Duke University will serve as the biorepository for the GBPDC. Participants and study site personnel will collect, process, and ship biospecimens according to the GBPDC Biorepository Manual of Procedures using standard kits assembled specifically for the GBPDC master protocol. Biospecimens will be shipped from the study sites to the GBPDC central biorepository at Duke University for accessioning, storage, tracking, and subsequent distribution for use in approved future research. Throughout the conduct of the master protocol, a portion of the biospecimens received by the GBPDC central biorepository will be transferred to the NIDDK biorepository for approved research use. Any biospecimen aliquots remaining at the GBPDC central biorepository at the termination of the GBPDC program will be transferred to the NIDDK biorepository.
Statistical Design This is a prospective, observational, longitudinal cohort study designed to characterize gut-brain communication in Parkinson's Disease. The study employs a longitudinal design, including cross-sectional analyses of baseline data, to evaluate gastrointestinal and neurological functions in participants with PD compared to household controls and a prodromal cohort, as well as comparisons among PD severity subgroups.
Study Design Features:
- Multi-center observational study across 5 GNRCs
- Three participant cohorts: people with PD, people with prodromal features of PD, and household controls. The PD cohort will be further classified as mild, moderate, or severe PD.
- Longitudinal design with assessments at baseline, 6, 12, 18, and 24 months
- Comprehensive biospecimen collection coordinated with clinical assessments
- Household control design where controls are matched to people with PD when available
- Conditions
- Parkinson Disease (PD), PARKINSON DISEASE (Disorder), Gut Microbiome, Gut Microbiota, Prodromal Parkinsons Disease
- Keywords
- gut brain, Parkinson's disease, Prodromal Parkinson's disease, healthy control
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Household Controls | Age-similar household controls. Household control design where controls are matched to people with PD when available. | |
| People with Parkinson's disease | The Parkinson's Disease (PD) cohort will be further classified as mild, moderate, or severe PD as classified by Hoehn and Yahr scale. | |
| Prodromal Parkinson's disease | People with Parkinson's Disease prodromal features. Prodromal characteristics are defined by the MDS Research Criteria for PD and include either polysomnography (PSG)-confirmed rapid eye movement sleep behavior disorder (RBD) or possible RBD (questionnaire-based), with hyposmia as defined by the University of Pennsylvania Smell Identification Test (UPSIT) ≤ 15th percentile. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI influences on PD
Trait and State cross-sectional evaluation of GI influences on PD
Measured: enrollment to end of observation at 24 months
Co-associations components of the GBA
Cross-sectional co-associations components of the GBA
Measured: enrollment to end of observation at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start3 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Chicago, Rush University Medical Center, Massachusetts General Hospital, Stanford University, Medical University of South Carolina, Columbia University, Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Lisa Wruck, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567794
- Sponsor's protocol ID
- Pro00115811
- Other IDs
- 5U24DK140918-02, 5U01DK140933-02, 5U01DK140923-02, 5U01DK140921-02, 5U01DK140936-02, 5U01DK140939-02
- Acronym
- GBPDC
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD related to the GBPDC will be shared via requests submitted through the NIDDK Central Repository.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consortium for Gut-Brain Communication in Parkinson's Disease Master Protocol
- ClinicalTrials.gov ID
- NCT07567794
- Acronym / sponsor ID
- GBPDC / Pro00115811
- Conditions
- Parkinson Disease (PD), PARKINSON DISEASE (Disorder), Gut Microbiome, Gut Microbiota, Prodromal Parkinsons Disease
- Keywords
- gut brain, Parkinson's disease, Prodromal Parkinson's disease, healthy control
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Chicago, Rush University Medical Center, Massachusetts General Hospital, Stanford University, Medical University of South Carolina, Columbia University, Mayo Clinic
- Study start
- 3 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 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.
The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study.
During this study, specific groups of participants, also known as "cohorts", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection.
Participants in this study will:
- meet with a medical provider
- answer questionnaires
- give samples of blood, stool, and saliva
- have X-rays taken while swallowing different foods (swallowing study)
- have X-rays taken to see how long it takes markers to move through their colon (colon transit study)
- have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining)
- have samples taken of their skin
- have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function.
Participation in the study will last up to 24 months (2 years).
Detailed description
The objectives of the master protocol are to establish a common platform that: (1) assures the collection, integration, and analysis of a set of uniformly collected data across all participating centers, and (2) follows the objective of the Gut-Brain Parkinson's Disease Consortium (GBPDC) with the goal "to enhance our understanding of the temporal onset of GI symptoms in PD and changes in gut-brain communication that can be used to leverage the potential role of the GI tract in the pathogenesis and progression of PD and to improve patient diagnosis, care, and outcomes."
Primary Objective
- To collect prospective cross-sectional and longitudinal participant biospecimens with temporally coordinated evaluations of GI and neurological symptoms and functions to better characterize the phenotype of people with PD versus those without.
Secondary Objectives
- To elucidate the biological processes and pathways relevant to the role of the GI tract in the pathogenesis and progression of PD.
- To characterize GI symptoms, pathology, and gut-brain communication in PD to detect early and longitudinal changes in gut function and activity that correspond to the development or progression of PD.
Exploratory Objectives
- To identify possible novel gut-based biomarkers (functional, molecular, etc.), diagnostic tools, and therapeutic targets.
- To investigate the impact of neuroimmune interactions and other pathways in the GI tract on gut-brain communication and PD risk.
In conjunction with clinical, social, and environmental characterization, biospecimen collection within the GBPDC master protocol will provide the opportunity to probe and characterize the pathophysiologic underpinnings of the gut-brain axis in PD, refine existing biomarker testing for PD, and identify new biomarkers that could allow early detection of PD or new targets for treatment.
Duke University will serve as the biorepository for the GBPDC. Participants and study site personnel will collect, process, and ship biospecimens according to the GBPDC Biorepository Manual of Procedures using standard kits assembled specifically for the GBPDC master protocol. Biospecimens will be shipped from the study sites to the GBPDC central biorepository at Duke University for accessioning, storage, tracking, and subsequent distribution for use in approved future research. Throughout the conduct of the master protocol, a portion of the biospecimens received by the GBPDC central biorepository will be transferred to the NIDDK biorepository for approved research use. Any biospecimen aliquots remaining at the GBPDC central biorepository at the termination of the GBPDC program will be transferred to the NIDDK biorepository.
Statistical Design This is a prospective, observational, longitudinal cohort study designed to characterize gut-brain communication in Parkinson's Disease. The study employs a longitudinal design, including cross-sectional analyses of baseline data, to evaluate gastrointestinal and neurological functions in participants with PD compared to household controls and a prodromal cohort, as well as comparisons among PD severity subgroups.
Study Design Features:
- Multi-center observational study across 5 GNRCs
- Three participant cohorts: people with PD, people with prodromal features of PD, and household controls. The PD cohort will be further classified as mild, moderate, or severe PD.
- Longitudinal design with assessments at baseline, 6, 12, 18, and 24 months
- Comprehensive biospecimen collection coordinated with clinical assessments
- Household control design where controls are matched to people with PD when available
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Household Controls | – | –Age-similar household controls. Household control design where controls are matched to people with PD when available. |
| People with Parkinson's disease | – | –The Parkinson's Disease (PD) cohort will be further classified as mild, moderate, or severe PD as classified by Hoehn and Yahr scale. |
| Prodromal Parkinson's disease | – | –People with Parkinson's Disease prodromal features. Prodromal characteristics are defined by the MDS Research Criteria for PD and include either polysomnography (PSG)-confirmed rapid eye movement sleep behavior disorder (RBD) or possible RBD (questionnaire-based), with hyposmia as defined by the University of Pennsylvania Smell Identification Test (UPSIT) ≤ 15th percentile. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the NIDDK designated Gastroenterology Neurology Research Centers
Key inclusion criteria (10 listed)
- Aged ≥21 years old and ≤80 years old
- Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria
- Adequate visual, hearing, cognitive, and physical ability
- Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. Because longitudinal participation is important to the scientific goals of the program, a "best estimate" of interest, commitment, and geographic feasibility for three years will be documented by the enrolling investigator after interview with the potential enrollee
- Aged ≥21 years old and ≤80 years old
Key exclusion criteria (22 listed)
- Diagnosis of secondary or atypical parkinsonism
- Laboratory Values:
- Currently taking anticoagulants that are deemed exclusionary by the investigator for risk of bleeding with sigmoidoscopy procedure
- Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score <22
- Clinical or laboratory findings consistent with another primary neurodegenerative disease or cognitive disorder other than PD, including but not limited to, frontotemporal lobar disease, Huntington's disease, progressive supranuclear palsy, multisystem atrophy, Creutzfeld-Jakob- Disease, Down's syndrome, cortico-basal degeneration, dementia with Lewy Bodies, Alzheimer's disease, amyotrophic lateral sclerosis, seizure disorder, stroke, or other infectious, metabolic, or systemic disease affecting the central nervous system including, but not limited to, syphilis, present hypothyroidism, present or unaddressed/treated vitamin B12 deficiency, or other screening laboratory abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GI influences on PD
Time frame: enrollment to end of observation at 24 months
Trait and State cross-sectional evaluation of GI influences on PD
Co-associations components of the GBA
Time frame: enrollment to end of observation at 24 months
Cross-sectional co-associations components of the GBA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD related to the GBPDC will be shared via requests submitted through the NIDDK Central Repository.
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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.
Lisa Wruck principal investigator
Duke Clinical Research Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease (PD) and PARKINSON DISEASE (Disorder), run by Duke University at 7 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 10 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI influences on PD (time frame: enrollment to end of observation at 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.