Placebo Controlled Alpha-gal Pork Challenge
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 主要终点
- Composite GI symptom score
研究概览
简要总结
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.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
Composite GI symptom score
时间窗: 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.
次要结局
- Tryptase(Serial samples from 0 to 5 hours post-challenge)
- Histamine/Methyl-histamine(Serial samples from 0 to 6 hours post-challenge)
- 11Beta-PGF2-alpha(Serial samples from 0 to 6 hours post-challenge)
研究者
Jeffrey Wilson, MD
Assistant Professor of Medicine
University of Virginia