Allogeneic microbiota-reconstitution (AMR) for the Treatment of patients with diarrhea-predominant irritable bowel Syndrome (IBS-D) - the AMIRA trial - AMIRA-trial

niversity of Ulm0 个研究点目标入组 42 人开始时间: 2016年9月30日最近更新: 2024年6月18日

试验速览

暂无简介。

•age 18-70 years old
•written informed consent
•Irritable bowel Syndrome of diarrhea-predominant type according to ROME III criteria
•duration of symptoms > 1 year before study inclusion
•persistent symptoms for > 1 year before study inclusion
•relevant ailments or symptoms resulting in the reduction in the quality of life according to the IBS-QOL Questionnairs (Score < 60 Points) in the last 6 months before study inclusion
•no specific findings in gastroscopy and colonoscopy in the last 2 years
•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 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•chronic inflammatory diseases
•gastrointestinal infectious diseases
•microscopic colitis
•celiac disease
•Diarrhoea due to suspected fructose or lactose intolerance
•Presence of gastrointestinal malignancy or intestinal polyps
•irritable bowel Syndrome of other type then IBS-D
•Presence of Bile acid diarrhoea (BAD)
•constipation
•Abdominal ailment or symptom caused by conditions other then IBS-D
•Recent abdominal operations
•antibiotic therapy in the last 3 months
•Unwillingness to use proven highly effective contraceptive methods by a woman with child-bearing potential for the duration of the study
•Concurrent participation in another clinical study
•Inability to provide informed consent

发起方

niversity of Ulm