EUCTR2019-000245-12-DE进行中（未招募）1 期
Controlled clinical trial to evaluate the efficacy and safety of MYRRHINIL-INTEST® versus placebo in patients with diarrhea-dominant irritable bowel syndrome (IBS-D) and patients with mixed-type irritable bowel syndrome (IBS-M) - MYNIBOS
Repha GmbH0 个研究点目标入组 140 人开始时间: 2019年10月4日最近更新:
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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
- 140
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
- •- IBS-D or IBS-M diagnostic confirmed according to Rome IV criteria
- •- Recurrent abdominal pain in the last three months (six months prior to
- •diagnosis) on average at least one day per week associated with at least
- •one of the following factors:
- •- associated with defecation
- •- associated with a change in stool frequency
- •- associated with a change in stool consistency
- •- Evaluation of the IBS-D or IBS-M symptoms:
- •o NRS pain > 3 points at visit 1 and visit 2; the value of NRS pain at visit
- •2 differs from that at visit 1 by max. 1 point
- •o IBS-SSS > 75 points on visit 1 and visit 2; the value of the IBS-SSS on
- •visit 2 differs from that on visit 1 by max. 25 points
- •o stool consistency documented by the patient using the Bristol stool
- •form scale. Evaluation according to Rome IV criteria:
- •Diarrhoe-dominant IBS (IBS-D): If > 25% of bowel movements
- •according to Bristol stool
- •form scale type 6 - 7 and < 25% of bowel movements according to
- •Bristol stool form scale type 1 - 2
- •Mixed type IBS (IBS-M): If > 25% of bowel movements according to
- •Bristol stool form scale type 1 - 2 and > 25% of bowel movements
- •according to Bristol stool form scale type 6 - 7
- •o Stool frequency > 3 bowel movements/day or < 3 bowel
- •movements/week
- •- Exclusion of chronic inflammatory intestinal diseases (ulcerative colitis,
- •Crohn's disease, microscopic colitis, Syndrome of loss of bile acids):
- •- Colon examination (colonoscopy) carried out within the
- •past 5 years in patients> 55 years before Study Participation
- •- Stool sample analyses (samples from visit 1, results have to be
- •available at visit 2):
- •o Exclusion of blood in stool,except:
- •- Blood traces due to local irritation and/or an anal fissure due to frequent defecation or hard stool consistency (determined by local inspection or a digital rectal examination).
- •- Blood traces due to hemorrhoids (detected by digital rectal examination or proctoscopy)
- •o Exclusion of clinically relevant increased calprotectin values (> 50
- •µg/g) in stool
- •o Exclusion of Clostridium difficile infection by Glutamate
- •Dehydrogenase (GDH) ELISA
- •o Exclusion of yersiniosis
- •- the Patient did not experience the following symptoms since disease
- •o weight loss within the last 6 months
- •o nocturnal symptoms (e.g. abdominal pain, diarrhoea)
- •o Anamnesis with relatives of 1st degree with colon carcinoma
- •- Presence of a declaration of 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 persons capable of giving birth
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- 另有 3 项未显示
排除标准
- •a) Diseases 1. confirmed diagnosis of microscopic colitis, ulcerative colitis or Crohn'sdisease 2. confirmed diagnosis of constipation subtype IBS (IBS-C) or undefinedIBS (IBS-U) according to Rome IV criteria 3. suspicion of acute appendicitis 4. if stool tests have been performed in the previous 6 months prior to inclusion in the study: o Exclusion of blood in stool,except: - Blood traces due to local irritation and/or an anal fissure due to frequent defecation or hard stool consistency (determined by local inspection or a digital rectal examination).- Blood traces due to hemorrhoids (detected by digital rectal examination or proctoscopy) o Positive test for parasites and worm eggs o clinically relevant increased calprotectin values (> 50 µg/g) in stool 5. diagnosed infectious gastroenteritis 6. known anomalies of the gastrointestinal tract (e.g. megacolon) or known diseases resulting in an altered gastrointestinal passage (e.g. colonic polyps) 7. liver or kidney dysfunction8. patients with known or suspected gallbladder inflammation (cholangitis), gallstones, Syndrome of loss of bile acids, obstruction of the bile ducts or other gallbladder diseases, sphincter oddi dysfunction or abdominal adhesions 9. past or suspected pancreatitis, ileus or gastrointestinal bleeding 10. female patients with known endometriosis 11. patients with gastroesophageal reflux disease (GERD) 12. known or suspected other reasons for diarrhoea: celiac disease; fructose, lactose, sorbitol intolerance or other intolerances leading to symptoms of diarrhoea 13. 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 14. known autoimmune diseases in the gastrointestinal tract 15. immunocompromised patients (patients with organ transplantation within the previous 3 years, patients with known HIV infection, etc.) 16. condition after partial colon resections 17. known diabetes mellitus, type I and/or type II 18. Inadequate drug medication for known hyperthyroidism, hypothyroidism, Hashimoto's thyroiditis, or evidence of thyroid dysfunction according to visit 1 blood results and at the investigator's discretion. 19. known hypersensitivity to myrrh, chamomile flowers or any of the adjuvants of MYRRHINIL-INTEST® or placebo
- •20. 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. This is assessed by the investigator treating the patient.
- •b) Medication 1. taking neuroleptics up to 1 month before the start of the study and during participation in the study 2. taking antibiotics within the last 10 days before the start of the study and/or during participation in the study 3. taking of systemic corticosteroids up to 1 month before the start of the study and during participation in the study 4. taking medication to treat IBS-D or IBS-M (including herbal and probiotic medicines) at visit 1 and within the last 30 days prior to the start of the study 5. continued use of NSAIDs (non-steroidal anti-inflammatory drugs, e.g. ibuprofen) for more than 14 days (excluding NSAIDs used as low-dose thrombosis prevention medication, e.g. acetylsalicylic acid or to treat adverse events) 6. intake of iron preparations and cardiac glycosides 7. Intake of opioids
- •c) General ana
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