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
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- T78.1
- 发起方
- Heilerde-Gesellschaft Luvos Just GmbH % Co. KG
- 入组人数
- 114
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
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.
结局指标
主要结局
未指定
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