Allergy;FoodNCT04828317
Alpha-gal Pork Challenge
A study testing Pork Challenge in people with Allergy;Food, run by University of Virginia.
Trial summary
This study is investigating the hypothesis that alpha-gal is responsible for the gastrointestinal symptoms that occur in some alpha-gal syndrome subjects following the consumption of mammalian meat. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy;Food
- What is being tested?
- Pork Challenge
- Type of treatment
- Pill or oral medicine
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 30 Apr 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Alpha-gal cases:
- Age 18-70
- Patient report of episodic GI symptoms within past 6 months that correlated with ingestion of mammalian meat and/or dairy and which improved on a mammalian avoidance diet.
- IgE to α-Gal >0.1 IU/mL at screening visit.
- Willingness and ability to comply with scheduled visits and study procedures.
- Control subjects:
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- Age 18-70
- Regularly consume/tolerate mammalian meat without obvious associated gastrointestinal or skin symptoms.
- Have eaten mammalian meat within the past 2 weeks
- Willingness and ability to comply with scheduled visits and study procedures.
Who cannot join
- Alpha-gal cases:
- History of anaphylaxis that was or could have been attributed to mammalian meat in the estimation of the PI.
- IgE to pork which exceeds the value of IgE to α-Gal on screening test
- Unexplained, persistent urticaria or pruritis.
- Pregnancy, breastfeeding or lack of birth control in women of child-bearing age.
- At the discretion of the principal investigator, patients may be excluded due to poorly controlled chronic gastrointestinal conditions including but not limited inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis, microscopic colitis), acid reflux/heartburn, history of bariatric surgery or gastric banding, active peptic ulcer disease or any abdominal surgery within the past 2 months.
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- Patient is unable to swallow food or has poor peripheral access.
- Patient has any medical or physiological disorder or condition that, in the opinion of the Investigator, would compromise the well-being of the patient or study or prevent the patient from meeting or performing study requirements.
- Control subjects:
- History of anaphylaxis that was or could have been attributed to mammalian meat in the estimation of the PI
- Unexplained, persistent urticaria or pruritis.
- Poorly controlled chronic gastrointestinal problem
- Patient is unable to swallow food or has poor peripheral access
- Patient has any medical or physiological disorder or condition that, in the opinion of the Investigator, would compromise the well-being of the patient or study or prevent the patient from meeting or performing study requirements.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Placebo Controlled Alpha-gal Pork Challenge
This study is investigating the hypothesis that alpha-gal is responsible for the gastrointestinal symptoms that occur in some alpha-gal syndrome subjects following the consumption of mammalian meat. This will be tested by comparing symptoms and immune responses in subjects with alpha-gal syndrome following consumption of "wild-type" pork (which contains alpha-gal) versus consumption of a novel pork product which has been genetically modified to lack alpha-gal (GalSafe pork from Revivicor Inc.).
- Conditions
- Allergy;Food
- Being tested
- Pork Challenge
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pork ChallengeOther
Double blind oral challenges comparing wild-type and alpha-gal free pork.
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite GI symptom score
GI symptoms will be assessed using modified FAST diary. Score is determined from a survey of five gastrointestinal symptoms obtained at 0,1,3,5 hours following oral pork challenge. Symptoms are measured via numerical rating scale (1-5) and aggregate score will be calculated.
Measured: Score is calculated from survey of gastrointestinal symptoms between 1 and 5 hours after challenge. .
Secondary outcomes (3)
Tryptase
Serum tryptase levels (ng/mL) will be quantified with ImmunoCap comparing post-challenge levels with baseline.
Measured: Serial samples from 0 to 5 hours post-challenge
Histamine/Methyl-histamine
Histamine and methyl-histamine (ng/mL) from serum and urine samples will be quantified with ELISA comparing post-challenge to baseline.
Measured: Serial samples from 0 to 6 hours post-challenge
11Beta-PGF2-alpha
11Beta-PGF2-alpha (pg/mL), a PGD2 metabolite, will be quantified in serum and urine with ELISA comparing post-challenge to baseline
Measured: Serial samples from 0 to 6 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 posted2 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy;FoodStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Wilson, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828317
- Sponsor's protocol ID
- HSR200447
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Alpha-gal Pork Challenge
- ClinicalTrials.gov ID
- NCT04828317
- Acronym / sponsor ID
- HSR200447
- Conditions
- Allergy;Food
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 2 Apr 2021 (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 is investigating the hypothesis that alpha-gal is responsible for the gastrointestinal symptoms that occur in some alpha-gal syndrome subjects following the consumption of mammalian meat. This will be tested by comparing symptoms and immune responses in subjects with alpha-gal syndrome following consumption of "wild-type" pork (which contains alpha-gal) versus consumption of a novel pork product which has been genetically modified to lack alpha-gal (GalSafe pork from Revivicor Inc.).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-70
- Patient report of episodic GI symptoms within past 6 months that correlated with ingestion of mammalian meat and/or dairy and which improved on a mammalian avoidance diet.
- IgE to α-Gal >0.1 IU/mL at screening visit.
- Willingness and ability to comply with scheduled visits and study procedures.
- Age 18-70
Key exclusion criteria (14 listed)
- History of anaphylaxis that was or could have been attributed to mammalian meat in the estimation of the PI.
- IgE to pork which exceeds the value of IgE to α-Gal on screening test
- Unexplained, persistent urticaria or pruritis.
- Pregnancy, breastfeeding or lack of birth control in women of child-bearing age.
- At the discretion of the principal investigator, patients may be excluded due to poorly controlled chronic gastrointestinal conditions including but not limited inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis, microscopic colitis), acid reflux/heartburn, history of bariatric surgery or gastric banding, active peptic ulcer disease or any abdominal surgery within the past 2 months.
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 |
|---|---|---|
| Pork ChallengeDouble blind oral challenges comparing wild-type and alpha-gal free pork. | Other | – |
Primary outcome
Composite GI symptom score
Time frame: Score is calculated from survey of gastrointestinal symptoms between 1 and 5 hours after challenge. .
GI symptoms will be assessed using modified FAST diary. Score is determined from a survey of five gastrointestinal symptoms obtained at 0,1,3,5 hours following oral pork challenge. Symptoms are measured via numerical rating scale (1-5) and aggregate score will be calculated.
3 secondary outcomes
Tryptase
Time frame: Serial samples from 0 to 5 hours post-challenge
Histamine/Methyl-histamine
Time frame: Serial samples from 0 to 6 hours post-challenge
11Beta-PGF2-alpha
Time frame: Serial samples from 0 to 6 hours post-challenge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Pork Challenge in people with Allergy;Food, run by University of Virginia.
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 14 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: status not confirmed, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Wilson, MD, PhD (434-243-8674, jmw2gc@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite GI symptom score (time frame: Score is calculated from survey of gastrointestinal symptoms between 1 and 5 hours after challenge. .). 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 2 Apr 2021.