EUCTR2019-000307-32-DE进行中（未招募）1 期
Clinical trial for examination of efficacy and safety of MYRRHINIL-INTEST® versus placebo in patients with diarrhea-dominant irritable bowel syndrom (IBS-D) - MINDAS
Repha GmbH0 个研究点目标入组 220 人开始时间: 2020年3月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients of both sexes aged =18 and = 75 years
- •confirmed IBS-D diagnostic to visit 1
- •performed colon examination (coloscopy) by patients > 55 years within the last 5 years before study participation
- •stool frequency: before visit 1 (screening) in the last 7 days on at least 3 days 1 watery stool/day
- •Evaluation of the IBS-D symptoms:
- •o NRS pain > 3 points at visit 1 and visit 2
- •o stool consistency documented by the patient using the Bristol stool form scale to visit 1 and 2
- •Stool sample analysis for exclusion of blood in stool (faecal occult blood) and exclusion of Clostridium difficile infection by Glutamate-dehydrogenase- (GDH-) ELISA by inclusion in the study (results at visit 2)
- •Presence of an informed consent signed by the patient
- •Understanding that changes in lifestyle and eating habits are avoided during the study period
- •Willingness to keep a regular patient diary
- •Negative pregnancy test for childbearing persons
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •shortened due to character limit:
- •a) Diseases
- •1. confirmed diagnosis of microscopic colitis, ulcerative colitis or Crohn's disease
- •2. confirmed diagnosis of constipation subtype IBS (IBS-C), mixed-type IBS (IBS-M) or undefined IBS (IBS-U)
- •3. Since disease: weight loss in the last 6 months (clinically significant, at the investigator's discretion), nocturnal symptoms, anamnesis by first degree relatives with colon carcinoma
- •4. suspicion of acute appendicitis
- •5. if stool tests have been performed in the previous 6 months prior to inclusion in the study:
- •- positive test for blood in stool (except for admixtures due to hemorrhoids or traces of blood due to local irritation due to frequent defecation)
- •- positive test for parasites and worm eggs
- •- clinically relevant increased calprotectin values (> 50 µg/g) in stool
- •6. diagnosed infectious gastroenteritis
- •7. known anomalies of the gastrointestinal tract (e.g. megacolon) or known diseases resulting in an altered gastrointestinal passage (e. g. colonic polyps)
- •8. liver or kidney dysfunction (serum creatinine, serum AST or ALT at least 3 times above the reference value in the last 12 months prior to inclusion in the study and during the study)
- •9. patients with known or suspected gallbladder inflammation (cholecystitis), gallstones, bile acid malabsorption, obstruction of the bile ducts or other gallbladder diseases, sphincter oddi dysfunction or abdominal adhesions
- •10. past or suspected pancreatitis, ileus or gastrointestinal bleeding
- •11. endometriosis
- •12. patients with gastroesophageal reflux disease (GERD) above 2b
- •13. known or suspected other reasons for diarrhoea: celiac disease; fructose, lactose, sorbitol intolerance or other intolerances
- •14. patients with malignant diseases or cancer treatments of the gastrointestinal tract in the last 5 years, as well as all other areas of the body in the last 2 years before inclusion in the study with continuing risk potential
- •15. known autoimmune diseases in the gastrointestinal tract
- •16. immunocompromised patients
- •17. condition after partial colon resections
- •18. diabetes mellitus, type I and/or type II
- •19. inappropriate medication setting with known hyper- or hypothyroidism, Hashimoto's thyroiditis or signs of thyroid dysfunction
- •20. hypersensitivity to chamomile, other daisies, myrrh, coffee charcoal, chamomile flowers or one of the other components of the test medication or the placebo.
- •21. hereditary problems of fructose / galactose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency
- •22. Serious somatic/psychosomatic, neurological and/or psychiatric conditions diagnosed and making it difficult for the patient to make an informed decision about consent to participate in the clinical trial
- •b) Medication (shortened due to character limit)
- •1. taking neuroleptics
- •2. taking antibiotics
- •3. taking of systemic corticosteroids
- •4. taking medication to treat IBS-D (exception of study medication and emergency medication)
- •5. continued use of NSAID for more than 14 days (except for low-dose NSAID for thrombosis prevention or treatment of AEs)
- •6. intake of opioid till 1 month before study start and during study participation
- •7. intake of cardiac glycosides
- •c) General anamnesis
- •1. patients who participated or are participating (screening) in other clinical trials 30 days prior to the initial inclusion examination or during the clinical trial, or who previously participated in the same trial (randomization)
- •2. patients with a dis
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