ISRCTN18410689已完成4 期
A double blind-cross-over, parallel, randomized, multicenter study to evaluate the safety and efficacy of LTS035 (Lactosectan) vs placebo in adult subjects with intolerance to certain foods, primarily lactose intolerant
ovintethical Pharma SA0 个研究点目标入组 60 人开始时间: 2021年12月16日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36076786/ (added 06/01/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 to 64 years with a current or recently reported history of dairy intolerance of at least 1-month duration
- •2. Caucasian race
- •3. Willing to sign the informed consent form
排除标准
- •1. Pregnant or breastfeeding women
- •2. Unwilling to sign the informed consent form
- •3. Allergy to one of the product ingredients
- •4. Cannot to come to the study visits
- •5. Patients with celiac disease
- •6. Patients with gastroenteritis
- •7. Patients with Crohn’s disease
- •8. Using lactase enzyme tablets or drops
- •9. Used antibiotics in the last 4 weeks
- •10. Used laxatives in the last 2 weeks
- •11. Laxatives used for a colonoscopy within the last 2 weeks
- •12. Diabetic patients
研究者
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