Enterosgel® in treatment of acute diarrhoea in adults

Not Applicable

Completed

• Conditions: Acute diarrhoea; Infections and Infestations

• Registration Number: ISRCTN20758708
• Lead Sponsor: Enteromed Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-21
• Study Completion: 2018-07-18
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 105

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
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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of acute diarrhoea, measured using daily patient diaries throughout the study