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

Synformulas GmbH0 sites507 target enrollmentApril 11, 2016

Overview

Registry

who.int

Start Date

April 11, 2016

End Date

April 15, 2017

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•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

•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