NCT06702280尚未招募1 期
Assessing the Safety of an IGY Supplement on the Gut Microbiome
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Primary Outcome
研究概览
简要总结
This study is to evaluate whether Muno-IgY is effective in enhancing immune health among adults over a six week period.
详细描述
The goal of this single-arm interventional trial is to evaluate the safety and effectiveness of Muno-IGY in a sample population of 20 healthy adults over a six week period. The intervention will be compared to a baseline before ingestion of the supplement with both qualitative questionnaires, a daily diary, and microbiome data gathered by the SIMBA and LIMBA capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-65 years old at the inclusion of the study, both female and male subjects.
- •Signed Informed Consent; willing and able to comply with study procedures.
- •Willing to maintain their diet and physical activity levels during the study.
- •Able to swallow a 25mm x 9mm sized capsule
排除标准
- •Use of regular prescription medications, including antihypertensives, anti-inflammatory drugs, corticosteroids, immunosuppressants, antidepressants, antipsychotics, anti-diabetic medications, and anti-arrhythmic agents, which in the opinion of the investigator, would adversely affect study safety or outcome.
- •Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, cancer diagnosis or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.
- •History of known structural gastrointestinal abnormalities such as structures or fistulas which may lead to mechanical obstruction.
- •Use of any medications in the week prior to the SIMBA or LIMBA capsule ingestions, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, anticholinergics, GLP-1 analogues); laxative and prokinetic use is allowed if it is kept unchanged in the week prior to the SIMBA and LIMBA capsule ingestions. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the capsules and PPI treatment is resumed only 4 hours thereafter.
- •Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.
- •Any significant gastrointestinal, heart, liver, lung, kidney, blood, endocrine or nervous system disease, which in the opinion of the investigator, would adversely affect study safety or outcome.
- •Cancer diagnosis or treatment within the past year (non-melanoma skin cancers are acceptable).
- •History or diagnosis of immunological or infectious disease (hepatitis, tuberculosis, HIV, Parkinson's).
- •History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.
- •Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.
- •Consumption of probiotic or prebiotic supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed.
- •Any prior Fecal Microbiota Transplantation.
- •Colon cleanses/bowel prep for 2 weeks
- •Pregnant or breastfeeding.
- •Planning to become pregnant.
- •Alcohol or drug abuse.
- •Egg allergy
- •Vegan diet, or other diet where ingestion of eggs is not suitable
- •History of less than 3 bowel movements per week.
- •Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed
结局指标
主要结局
Primary Outcome
时间窗: Through study completion (Baseline to the end of the interventional period), an average of 6 weeks
To assess the safety of Muno-IgY™ in the small intestine. By monitoring the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
次要结局
- Secondary 1(Through study completion (Baseline to the end of the interventional period), an average of 6 weeks)
- Secondary 2(Through study completion (Baseline to the end of the interventional period), an average of 6 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency DisordersPrimary Immunodeficiency Diseases (PID)Immune Thrombocytopenic Purpura (ITP)Kawasaki SyndromeNCT00157079Baxalta now part of Shire61
已完成
不适用
ipid emulsion (drug) in Acute on Chronic Liver Failure (Liver Disease).CTRI/2018/04/012995Institute of liver and Biliary Sciences90
已完成
3 期
Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)Primary Immune DeficiencyNCT00719680CSL Behring21
尚未招募
3 期
Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIGPrimary Immunodeficiency DiseaseNCT06089122Azidus Brasil50
已完成
4 期
Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki DiseaseKawasaki DiseaseNCT04003844Green Cross Corporation45