A randomized, double-blinded, placebo-controlled, clinical trial investigating the efficacy and safety of gelatin tannate and tyndallized acid lactic bacteria vs placebo administered to adult patients with chronic diarrhoea with dysbiosis

oventure S.L.0 个研究点目标入组 190 人开始时间: 2020年10月23日最近更新: 2020年11月2日

试验速览

暂无简介。

•1. Chronic diarrhoea defined as a morbid process of at least 4 weeks of duration and a change in stool consistency to loose or liquid form (types 5-7, according to the Bristol Stool Chart) and/or an increase in the frequency of evacuations (=3 in 24 h)
•2. Patients diagnosed with irritable bowel syndrome or functional diarrhoea (according to the Rome IV criteria) or biliary acid malabsorption
•3. Patients will be included if they record, during the week before randomization, an average score for stool consistency of =5.5 or a score of =5 on the Bristol Stool Chart for at least 5 days and an average score of =3.5 or a score of =3 for at least 5 days in the number of bowel movements
•4. Participants will be tested at baseline for functional intestinal dysbiosis (Aliment Pharmacol Ther 2012;35(7):828-38), as demonstrated by real-time PCR analysis of faecal samples
•5. Ability to sign the informed consent form

•1. Use of antibiotics, gelatin tannate, diosmectite, probiotics, racecadotril, zinc, opioids, or any other drugs or medical devices know to alter gastrointestinal motility or secretion within 4 weeks prior to enrolment
•2. Chronic diarrhoea caused by cystic fibrosis, coeliac disease, food allergy, diabetes
•3. Chronic diarrhoea caused by lactose, fructose, or sorbitol intolerance
•4. Immunodeficiencies
•5. Abnormal thyroid function, a history of alcohol abuse or binge drinking, pancreatitis, sphincter of Oddi dysfunction, cholecystitis within the past 6 months, or known allergy to any of the components of the product or placebo
•6. Pregnant or breastfeeding women
•7. Patients receiving antidepressant medications will be eligible to participate in the study, provided that dosing has been stable for 12 weeks or longer before enrollment
•8. If needed, discontinuation or modification of the treatment may be considered at the discretion of the physician

发起方

oventure S.L.