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Food challenge with pork meat without alpha gal sugar, then pork meat containing alpha-gal for Irritable Bowel 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 hours post ingestion

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours post ingestion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 hours post ingestion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours post ingestion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Allergic reaction (food challenge positive)

Basophil activation threshold response at 2 hours

Basophil activation threshold response at 4 hours

+13 more

Trial Design

2Treatment groups

Active Control

Group I: 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.

Group II: 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,191,018 Total Patients Enrolled

6 Trials studying Irritable Bowel Syndrome

449 Patients Enrolled for Irritable Bowel Syndrome

Revivicor, IncUNKNOWN

Sarah McGill, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants still able to apply for enrollment in this ongoing research study?

"As per the details on clinicaltrials.gov, this investigation is currently in search of suitable participants. The study was initially shared on October 17, 2023, and its most recent update was made on February 12, 2024."

Answered by AI

How many patients are currently undergoing treatment in this clinical trial?

"Indeed, as indicated on clinicaltrials.gov, this investigation is actively seeking candidates. The trial was first made public on October 17th of the year 2023 and received its latest update on February 12th in the year 2024. To complete the study, a total of 24 participants will be enrolled at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GI Alpha-Gal Study

2023. "GI Alpha-Gal Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06268717.

All > Irritable Bowel Syndrome > Greensboro