Randomised, multi-centre study to assess efficacy, tolerability and safety of Enterosgel® in treatment of acute diarrhoea in adults

Enteromed Ltd0 个研究点目标入组 105 人开始时间: 2016年11月21日最近更新: 2022年8月22日

试验速览

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31139427 results (added 14/06/2019)

•Current inclusion criteria as of 19/05/2017:
•1. Informed consent
•2. Patient-reported episode of acute diarrhoea defined as at least 3 watery stools within the last 48 hours
•3. Aged 18 to 70
•4. Willing and able to comply with the study protocol and evaluation(s) specified in the protocol
•5. Considered suitable to take part in the study by the consenting GP/nurse (based on medical history and physical examination)
•Previous inclusion criteria:
•1. Informed consent
•2. Patient-reported episode of acute diarrhoea defined as at least 3 watery stools within the last 48 hours
•3. Aged 18 to 55
•4. Willing and able to comply with the study protocol and evaluation(s) specified in the protocol
•5. Considered suitable to take part in the study by the consenting GP (based on medical history and physical examination)

•1. History of intestinal atony (severe constipation due to bowel obstruction)
•2. Blood in stools
•3. Any underlying condition that could cause chronic diarrhoea (such as gastroduodenal ulcer, ulcerative colitis, or Crohn’s disease)
•4. Patients with known cancer of any localisation
•5. Use of any clinical trial investigational medication within the last 30 days before screening visit
•6. Use of antibiotics since the onset of current diarrhoea episode
•7. Pregnancy
•8. A history of clinically significant allergic reactions
•9. Any underlying condition that could affect the patient’s participation in this study or the results of this study in the investigator’s opinion

发起方

Enteromed Ltd