Alpha-Gal SyndromeNCT06268717
GI Alpha-Gal Study
A study testing Ground pork containing alpha-gal and Pork meat not containing alpha-gal in people with Alpha-Gal Syndrome and Irritable Bowel Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Alpha-Gal Syndrome, Irritable Bowel Syndrome, Diarrhea
- What is being tested?
- Ground pork containing alpha-gal and Pork meat not containing alpha-gal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to 2 Jun 2026
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is at least 18 years of age.
- The subject has a history of gastrointestinal alpha-gal allergy defined by elevated test for α-gal allergy (α-gal IgE >0.1 U/L) due to complaints of either abdominal pain or discomfort, diarrhea, nausea with or without vomiting, or a combination of those complaints, within the last 5 years. The subjects must have experienced one or more of the four symptoms at least once monthly for at least two months. The subjects will fill out a symptom questionnaire of the presence of these four symptoms (abdominal pain or discomfort, diarrhea, nausea, vomiting), frequency and severity (mild, moderate, or severe) for the 3 months prior to diagnosis.
- The subject has experienced symptomatic improvement on a mammalian meat-free diet over at least a month's time, defined by saying "yes" to the following question: "On the alpha-gal avoidant diet, have you had adequate relief of gastrointestinal symptoms?"
- The subject has elevated α-gal IgE titer on screening for the trial if they do not have a positive titer within 6 months of enrollment.
- The subject is willing to not take nonsteroidal anti-inflammatory medications, leukotriene modifiers or steroids 14 days prior to challenge.
- The subject is willing to sign the informed consent form.
Who cannot join
- The subject has health conditions that would pose a significant threat in the face of anaphylaxis or treatment for anaphylaxis (e.g., cardiac disease, unstable angina pectoris, arrhythmias).
- The subject is allergic to mannitol.
- If female, the subject is pregnant.
- The subject has a history of chronic GI conditions, including inflammatory bowel disease, celiac disease, chronic pancreatitis with continued symptoms (experience moderate-severe abdominal pain, diarrhea, or nausea/vomiting that occur more frequently than once weekly)
- The subject has diarrhea (one or more loose stools that conform to the container), moderate to severe abdominal pain, or vomiting within 10 days prior to the challenge.
- The subject has a history of severe allergic reaction on mammalian meat ingestion (respiratory distress, chest pain or cardiopulmonary compromise)
Show all 15Show fewer
- The subject is unwilling to receive intramuscular epinephrine.
- The subject is anticipated to use omalizumab within 6 months of enrollment.
- The subject is anticipated to use systemic steroids within 28 days of food challenge.
- The subject is anticipated to use leukotriene modifier within 14 days of food challenge.
- The subject is unable to not use nonsteroidal anti-inflammatory drugs for 14 days prior to challenge.
- Additional Exclusion Criteria for Subjects Undergoing Transnasal Endoscopy and Biopsy
- Known conditions that are contraindications to transnasal endoscopy, or in the opinion of the investigator any condition that would interfere with the study objectives.
- History of head and neck malignancy or anatomical deformities of the nasopharynx
- Severe anxiety
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Understanding Gastrointestinal Alpha-Gal Syndrome: (GI Alpha-Gal Study)
This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms.
Read the detailed description
Each participant will be randomized to undergo two double-blind food challenges with at least a 10-day washout period between the challenges. One food challenge will contain pork meat with alpha gal sugar; one challenge will contain pork meat without the alpha gal sugar. During the challenges, participants will drink lactulose and C13 mannitol dissolved in water. The principal investigator and clinical research coordinators will be blinded to the challenges during the course of the study. The metabolic kitchen and a delegated research staff member will be unblinded.
On consenting patients, a transnasal upper endoscopy (TNE) will be performed on each challenge day, pre-challenge, at hour 0 and post-challenge, at hour 6. During the TNE, esophagus, stomach and small bowel samples will be collected. Gastrointestinal pathology samples will be evaluated for inflammatory cells and also biobanked for further messenger RNA (mRNA) sequencing studies.
Blood and urine will be collected during each challenge. Samples will be transported to a lab and analyzed for tryptase, basophil activation, and lactulose/ mannitol levels. The principal investigator may take pictures of the skin changes from participants who have skin changes such as rashes, hives, flushing, etc. during the challenge visits to assess the adverse events after getting consent.
- Conditions
- Alpha-Gal Syndrome, Irritable Bowel Syndrome, Diarrhea, Abdominal Pain, Vomiting
- Being tested
- Ground pork containing alpha-gal, Pork meat not containing alpha-gal
- Keywords
- Alpha-Gal Syndrome, diarrhea, abdominal pain, vomiting
- Medical subject headings
- red meat allergy, Irritable Bowel Syndrome, Diarrhea, Abdominal Pain, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ground pork containing alpha-galOther
150 grams of cooked, ground pork meat containing alpha-gal sugar eaten once
Pork meat not containing alpha-galOther
150 grams of cooked, ground pork meat not containing alpha-gal sugar
| Study group | Role | What they receive |
|---|---|---|
| Food challenge with pork meat containing alpha-gal, then pork meat without alpha gal sugar | Active comparator | Participants receive a food challenge, consuming pork meat that contains alpha-gal. After a >10-day washout period, participants undergo a food challenge with pork which does not contain alpha-gal. Receives: Other: Ground pork containing alpha-gal; Other: Pork meat not containing alpha-gal |
| Food challenge with pork meat without alpha gal sugar, then pork meat containing alpha-gal | Active comparator | Participants receive a food challenge consuming pork meat that does not contain alpha-gal sugar. After a >10-day washout period, participants undergo a food challenge with pork which does contain alpha-gal. Receives: Other: Ground pork containing alpha-gal; Other: Pork meat not containing alpha-gal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic reaction (food challenge positive)
Presence of allergic reaction within 6 hours of the challenge. Reported as dichotomous: food challenge positive (reaction) or food challenge negative (no reaction).
Measured: 6 hours post ingestion
No allergic reaction (food challenge negative)
No allergic reaction within 6 hours of the challenge. Reported as dichotomous: food challenge positive (reaction) or food challenge negative (no reaction).
Measured: 6 hours post ingestion
Lactulose excretion
C13 mannitol quantification with high-performance liquid chromatography- C13 mannitol excreted in the urine in the six hours following ingestion will be measured as a marker of intestinal permeability.
Measured: 0- 6 hours post ingestion
C13 mannitol excretion
C13 mannitol quantification with high-performance liquid chromatography- C13 mannitol excreted in the urine in the six hours following ingestion will be measured as a marker of intestinal permeability.
Measured: 0-6 hours post ingestion
Basophil activation threshold response at timepoint 0
Basophil activation threshold responses - peripheral blood basophils will be isolated and stimulated with mammal-based extracts to create a dose-response curve for concentrations of antigen leading to CD63 activation
Measured: 0 hours (prior to ingestion)
Basophil activation threshold response at 2 hours
Basophil activation threshold responses - peripheral blood basophils will be isolated and stimulated with mammal-based extracts to create a dose-response curve for concentrations of antigen leading to CD63 activation.
Measured: 2 hours post ingestion
Basophil activation threshold response at 4 hours
Basophil activation threshold responses - peripheral blood basophils will be isolated and stimulated with mammal-based extracts to create a dose-response curve for concentrations of antigen leading to CD63 activation.
Measured: 4 hours post ingestion
Basophil activation threshold response at 6 hours
Basophil activation threshold responses - peripheral blood basophils will be isolated and stimulated with mammal-based extracts to create a dose-response curve for concentrations of antigen leading to CD63 activation. Results pre- and post- pork challenge will be compared to assess for changes in basophil responses
Measured: 6 hours post ingestion
Serum tryptase at timepoint 0
Serum tryptase- serum tryptase levels will be quantified.
Measured: 0 hours (prior to ingestion)
Serum tryptase at 2 hours
Serum tryptase- serum tryptase levels will be quantified.
Measured: 2 hours post ingestion
Serum tryptase at 4 hours
Serum tryptase- serum tryptase levels will be quantified.
Measured: 4 hours post ingestion
Serum tryptase at 6 hours
Serum tryptase- serum tryptase levels will be quantified.
Measured: 6 hours post ingestion
Mast cell count on stomach biopsies (per high powered field (hpf))
The number of mast cells will be counted at high-powered field on biopsy specimens of the stomach.
Measured: 6 hours post ingestion
Mast cell count on small bowel biopsies (per high powered field (hpf))
The number of mast cells will be counted at high-powered field on biopsy specimens of the small bowel.
Measured: 6 hours post ingestion
Eosinophil cell count on stomach biopsies (per high powered field (hpf))
The number of eosinophil cells will be counted at high-powered field on biopsy specimens of the stomach.
Measured: 6 hours post ingestion
Eosinophil cell count on small bowel biopsies (per high powered field (hpf))
The number of eosinophil cells will be counted at high-powered field on biopsy specimens of the small bowel.
Measured: 6 hours post ingestion
Secondary outcomes (1)
GI Symptom Rating Score (GSRS)
The Gastrointestinal Symptom Rating Scale (GSRS) assesses gastrointestinal symptoms as experienced by participants in the 24-hours following a challenge. The scale covers 17 specific G1 symptoms, each rated on a 0-5 scale where 0 (no symptoms), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe), 5 (very severe)
Measured: 24 hours post challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start17 Oct 2023
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alpha-Gal SyndromeStudies 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
- Crossover
- Model description
- Double-blind crossover. Each participant will be randomized to undergo two double-blind food challenges with at least a 10-day washout period between the challenges. One food challenge will contain pork meat containing alpha-gal sugar; one challenge will contain pork meat without alpha-gal sugar.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Revivicor, Inc, American College of Gastroenterology
- Responsible party
- Sponsor
- Investigators
- Sarah McGill, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268717
- Sponsor's protocol ID
- 23-0316
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Gastrointestinal Alpha-Gal Syndrome: (GI Alpha-Gal Study)
- ClinicalTrials.gov ID
- NCT06268717
- Acronym / sponsor ID
- 23-0316
- Conditions
- Alpha-Gal Syndrome, Irritable Bowel Syndrome, Diarrhea, Abdominal Pain, Vomiting
- Keywords
- Alpha-Gal Syndrome, diarrhea, abdominal pain, vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Revivicor, Inc, American College of Gastroenterology
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 20 Feb 2024 (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 is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms.
Detailed description
Each participant will be randomized to undergo two double-blind food challenges with at least a 10-day washout period between the challenges. One food challenge will contain pork meat with alpha gal sugar; one challenge will contain pork meat without the alpha gal sugar. During the challenges, participants will drink lactulose and C13 mannitol dissolved in water. The principal investigator and clinical research coordinators will be blinded to the challenges during the course of the study. The metabolic kitchen and a delegated research staff member will be unblinded.
On consenting patients, a transnasal upper endoscopy (TNE) will be performed on each challenge day, pre-challenge, at hour 0 and post-challenge, at hour 6. During the TNE, esophagus, stomach and small bowel samples will be collected. Gastrointestinal pathology samples will be evaluated for inflammatory cells and also biobanked for further messenger RNA (mRNA) sequencing studies.
Blood and urine will be collected during each challenge. Samples will be transported to a lab and analyzed for tryptase, basophil activation, and lactulose/ mannitol levels. The principal investigator may take pictures of the skin changes from participants who have skin changes such as rashes, hives, flushing, etc. during the challenge visits to assess the adverse events after getting consent.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind crossover. Each participant will be randomized to undergo two double-blind food challenges with at least a 10-day washout period between the challenges. One food challenge will contain pork meat containing alpha-gal sugar; one challenge will contain pork meat without alpha-gal sugar.
| Arm | Type | Receives |
|---|---|---|
| Food challenge with pork meat containing alpha-gal, then pork meat without alpha gal sugar | Active comparator | Other: Ground pork containing alpha-gal, Other: Pork meat not containing alpha-galParticipants receive a food challenge, consuming pork meat that contains alpha-gal. After a >10-day washout period, participants undergo a food challenge with pork which does not contain alpha-gal. |
| Food challenge with pork meat without alpha gal sugar, then pork meat containing alpha-gal | Active comparator | Other: Ground pork containing alpha-gal, Other: Pork meat not containing alpha-galParticipants receive a food challenge consuming pork meat that does not contain alpha-gal sugar. After a >10-day washout period, participants undergo a food challenge with pork which does contain alpha-gal. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is at least 18 years of age.
- The subject has a history of gastrointestinal alpha-gal allergy defined by elevated test for α-gal allergy (α-gal IgE >0.1 U/L) due to complaints of either abdominal pain or discomfort, diarrhea, nausea with or without vomiting, or a combination of those complaints, within the last 5 years. The subjects must have experienced one or more of the four symptoms at least once monthly for at least two months. The subjects will fill out a symptom questionnaire of the presence of these four symptoms (abdominal pain or discomfort, diarrhea, nausea, vomiting), frequency and severity (mild, moderate, or severe) for the 3 months prior to diagnosis.
- The subject has experienced symptomatic improvement on a mammalian meat-free diet over at least a month's time, defined by saying "yes" to the following question: "On the alpha-gal avoidant diet, have you had adequate relief of gastrointestinal symptoms?"
- The subject has elevated α-gal IgE titer on screening for the trial if they do not have a positive titer within 6 months of enrollment.
- The subject is willing to not take nonsteroidal anti-inflammatory medications, leukotriene modifiers or steroids 14 days prior to challenge.
Key exclusion criteria (15 listed)
- The subject has health conditions that would pose a significant threat in the face of anaphylaxis or treatment for anaphylaxis (e.g., cardiac disease, unstable angina pectoris, arrhythmias).
- The subject is allergic to mannitol.
- If female, the subject is pregnant.
- The subject has a history of chronic GI conditions, including inflammatory bowel disease, celiac disease, chronic pancreatitis with continued symptoms (experience moderate-severe abdominal pain, diarrhea, or nausea/vomiting that occur more frequently than once weekly)
- The subject has diarrhea (one or more loose stools that conform to the container), moderate to severe abdominal pain, or vomiting within 10 days prior to the challenge.
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 |
|---|---|---|
| Ground pork containing alpha-gal150 grams of cooked, ground pork meat containing alpha-gal sugar eaten once | Other | Food challenge with pork meat containing alpha-gal, then pork meat without alpha gal sugar, Food challenge with pork meat without alpha gal sugar, then pork meat containing alpha-gal |
| Pork meat not containing alpha-gal150 grams of cooked, ground pork meat not containing alpha-gal sugar | Other | Food challenge with pork meat containing alpha-gal, then pork meat without alpha gal sugar, Food challenge with pork meat without alpha gal sugar, then pork meat containing alpha-gal |
Primary outcome
Allergic reaction (food challenge positive)
Time frame: 6 hours post ingestion
Presence of allergic reaction within 6 hours of the challenge. Reported as dichotomous: food challenge positive (reaction) or food challenge negative (no reaction).
No allergic reaction (food challenge negative)
Time frame: 6 hours post ingestion
No allergic reaction within 6 hours of the challenge. Reported as dichotomous: food challenge positive (reaction) or food challenge negative (no reaction).
Lactulose excretion
Time frame: 0- 6 hours post ingestion
C13 mannitol quantification with high-performance liquid chromatography- C13 mannitol excreted in the urine in the six hours following ingestion will be measured as a marker of intestinal permeability.
C13 mannitol excretion
Time frame: 0-6 hours post ingestion
C13 mannitol quantification with high-performance liquid chromatography- C13 mannitol excreted in the urine in the six hours following ingestion will be measured as a marker of intestinal permeability.
Basophil activation threshold response at timepoint 0
Time frame: 0 hours (prior to ingestion)
Basophil activation threshold responses - peripheral blood basophils will be isolated and stimulated with mammal-based extracts to create a dose-response curve for concentrations of antigen leading to CD63 activation
Basophil activation threshold response at 2 hours
Time frame: 2 hours post ingestion
Basophil activation threshold responses - peripheral blood basophils will be isolated and stimulated with mammal-based extracts to create a dose-response curve for concentrations of antigen leading to CD63 activation.
Basophil activation threshold response at 4 hours
Time frame: 4 hours post ingestion
Basophil activation threshold responses - peripheral blood basophils will be isolated and stimulated with mammal-based extracts to create a dose-response curve for concentrations of antigen leading to CD63 activation.
Basophil activation threshold response at 6 hours
Time frame: 6 hours post ingestion
Basophil activation threshold responses - peripheral blood basophils will be isolated and stimulated with mammal-based extracts to create a dose-response curve for concentrations of antigen leading to CD63 activation. Results pre- and post- pork challenge will be compared to assess for changes in basophil responses
Serum tryptase at timepoint 0
Time frame: 0 hours (prior to ingestion)
Serum tryptase- serum tryptase levels will be quantified.
Serum tryptase at 2 hours
Time frame: 2 hours post ingestion
Serum tryptase- serum tryptase levels will be quantified.
Serum tryptase at 4 hours
Time frame: 4 hours post ingestion
Serum tryptase- serum tryptase levels will be quantified.
Serum tryptase at 6 hours
Time frame: 6 hours post ingestion
Serum tryptase- serum tryptase levels will be quantified.
Mast cell count on stomach biopsies (per high powered field (hpf))
Time frame: 6 hours post ingestion
The number of mast cells will be counted at high-powered field on biopsy specimens of the stomach.
Mast cell count on small bowel biopsies (per high powered field (hpf))
Time frame: 6 hours post ingestion
The number of mast cells will be counted at high-powered field on biopsy specimens of the small bowel.
Eosinophil cell count on stomach biopsies (per high powered field (hpf))
Time frame: 6 hours post ingestion
The number of eosinophil cells will be counted at high-powered field on biopsy specimens of the stomach.
Eosinophil cell count on small bowel biopsies (per high powered field (hpf))
Time frame: 6 hours post ingestion
The number of eosinophil cells will be counted at high-powered field on biopsy specimens of the small bowel.
1 secondary outcome
GI Symptom Rating Score (GSRS)
Time frame: 24 hours post challenge
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 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Related trials for Alpha-Gal Syndrome
RecruitingPhase 2
Beginning to Assess an Appropriate CONtrol for Oral Food Challenges in Alpha-Gal Syndrome (CoFAR-13) - BeACON4AG
Alpha-Gal Syndrome, Allergy
RecruitingObservational study
The α-gal Syndrome - Investigating Immune Reactions to Tick Bites
Alpha-Gal Syndrome
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.
Sarah McGill, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ground pork containing alpha-gal and Pork meat not containing alpha-gal in people with Alpha-Gal Syndrome and Irritable Bowel Syndrome, run by University of North Carolina, Chapel Hill 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 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 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 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?
Allergic reaction (food challenge positive) (time frame: 6 hours post ingestion). The study lists 16 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 8 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.