DRKS00027333招募中4 期
Prospective, randomized, double-blind, placebo-controlled, multicenter clinical investigation to determine the clinical performance and safety of Luvos® Healing Earth in patients with histamine-mediated recurrent digestive symptoms. - 2020-02 LUVHIT
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 114
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Females and Males aged = 18 years, with recurrent upper or lower GI symptoms and known histamine pathophysiology in the gastrointestinal tract:
- •Recurrent digestive symptoms for which, based on previous full GI-diagnostics no other cause could be identified, and Symptomatic and/or diagnostic findings supporting a histamine-mediated pathophysiology.
排除标准
- •(1) Patients with severe allergic reactions (anaphylaxis, gastrointestinal mediated allergies grade IV);
- •(2) Treatment with corticosteroids, immunosuppressant’s, biologics, chemotherapeutics;
- •(3) Patients with short bowel syndrome, colon resection or intestinal stomas;
- •(4) Therapy with antibiotics within 4 weeks prior to inclusion in the clinical investigation, or ongoing hyposensitization treatment;
- •(5) Acute bacterial or viral infections that, at the discretion of the investigator, argues against inclusion of the patient in the clinical investigation;
- •(6) Other acute or chronic medical conditions of the patient that, in the investigator's judgment, argues against inclusion of the patient in the clinical investigation;
- •(7) Known allergic reactions to Healing Earth or other loess preparations;
- •(8) Pregnancy;
- •(9) Others.
研究者
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