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Pork with Alpha-Gal for Alpha-Gal Syndrome

N/A

Recruiting

Led By Sarah McGill, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The subject is at least 18 years of age

Be older than 18 years old

Must not have

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 is unwilling to receive intramuscular epinephrine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours post challenge

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing the effects of pork with and without α-gal on patients with GI- α-gal allergy to understand why they have symptoms."

Who is the study for?

This trial is for individuals with a clinical diagnosis of GI-alpha-gal allergy, which can cause symptoms like diarrhea, irritable bowel syndrome, abdominal pain, and vomiting. Specific eligibility criteria are not provided.

What is being tested?

The study tests the reaction to two types of pork: one containing alpha-gal and one without it. It's designed as a double-blind crossover challenge to understand how these foods affect patients with GI-alpha-gal allergy.

What are the potential side effects?

Potential side effects may include worsening of gastrointestinal symptoms such as increased diarrhea, abdominal pain, or vomiting when consuming pork containing alpha-gal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had diarrhea, severe stomach pain, or vomiting in the last 10 days.

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I am not willing to receive epinephrine shots.

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I have had cancer or deformities in my head, neck, or nasopharynx area.

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I am currently pregnant.

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I have chronic GI issues like IBD, celiac, or pancreatitis with frequent severe symptoms.

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I have severe anxiety.

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I have heart conditions that make allergic reactions dangerous for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours post challenge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours post challenge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post challenge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Allergic reaction (food challenge positive)

Basophil activation threshold response at 2 hours

Basophil activation threshold response at 4 hours

+13 more

Secondary study objectives

GI Symptom Rating Score (GSRS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Food challenge with pork meat containing alpha-gal, then pork meat without alpha gal sugarActive Control2 Interventions

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.

Group II: Food challenge with pork meat without alpha gal sugar, then pork meat containing alpha-galActive Control2 Interventions

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.

0 / 8Eligibility criteria met