ISRCTN14066467已完成未知
Randomised, double-blind, placebo-controlled, multicentre clinical trial for proving the efficacy of heat-inactivated Bifidobacterium bifidum SYN-HI-001 in the treatment of patients with irritable bowel syndrome
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 507
研究概览
简要总结
2020 results in https://pubmed.ncbi.nlm.nih.gov/32277872 (added 15/04/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with IBS, diagnosed according to the Rome-III-criteria
- •2. Otherwise healthy male or female subjects, aged between 18 and 65 years
- •3. Negative result of a sigmoidoscopy or coloscopy within the preceding 5 years for patients above 55 years of age
- •4. Legal capacity
- •5. Written consent of the patient
- •6. Understanding of the German language and compliance
- •7. Patient has understood, that changes in life style and nutrition habits have to be avoided
- •8. Patient has understood the principle of the patient-diary and is willing to keep it according to the requirements
- •9. Negative pregnancy test
排除标准
- •1. Inflammatory bowel diseases (Crohn's disease and Ulcerative colitis)
- •2. Systemic diseases, cancer, autoimmune diseases
- •3. Known abnormalities in abdomen region e.g. unusual ultrasound that would require further investigation
- •4. Ingestion of antipsychotics within the last 3 months prior to the start of the study. Ingestion of systemic Corticosteroids wihtin the last month prior to the start of the study.
- •5. Ingestion of medication influencing the efficacy of the tested product (i.e. analgetics, antibiotics, chemotherapeutics, antipsychotics, laxatives, spasmolytics, antidiarrhoeals)
- •6. Ingestion of other probiotic products
- •7. Serious psychiatric disorders within the last 2 years
- •8. Diabetes mellitus
- •9. Hyperthyroidism and hypothyroidism
- •10. Lactose intolerance or other malabsorption syndromes
- •11. Immune deficiency
- •12. Abdominal surgeries (exceptions include: appendectomies, hernia surgeries, cholecystectomy, sectio caesarea)
- •13. Coeliac disease
- •14. Known positive stool culture for patients with diarrhea-predominant IBS
- •16. Known parasites or eggs in stool
- •17. Laboratory abnormalities which would expose the patient to an unacceptable risk or influence intepretation of study data
- •18. Serious diseases resulting in a need for care, a need for a guardian or resulting in immobilisation
- •19. Alcohol or drug abuse
- •20. Pregnancy or lactation period
- •21. Participation in other interventional trials or participation in other interventional trials within the last 30 days
- •22. Nonautonomous individuals, not capable of making decisions independently e.g. due to a relationship with a sponsoring party or relationship with a physician, both of whom may be capable of pressuring the participant
研究者
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