ISRCTN20758708
Completed
未知
Randomised, multi-centre study to assess efficacy, tolerability and safety of Enterosgel® in treatment of acute diarrhoea in adults
Enteromed Ltd0 sites105 target enrollmentNovember 21, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Enteromed Ltd
- Enrollment
- 105
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31139427 results (added 14/06/2019)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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