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Clinical Trials/ISRCTN20758708
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)

Registry
who.int
Start Date
November 21, 2016
End Date
July 18, 2018
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Enteromed Ltd

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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