Acute diarrhoea Infections and Infestations
Conditions
Interventions
This is a 1-week randomised, multi-centre, post-marketing efficacy and safety study of a medical device used within its intended purpose. As in many medical device studies, use of placebo in this tria
If no loose stool or just once a day: 1 tablespoon or 1 sachet of Enterosgel® 3 times a
Sponsors
Enteromed Ltd
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of acute diarrhoea, measured using daily patient diaries throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/06/2018: 1. Percentage of patients with diarrhoea resolved on Day 3 (i.e. first soft or firm stool recorded on Day 0-3) 2. Stool frequency, defined as the average number of stools/day from randomisation to first soft or firm stool 3. Tolerance and safety of Enterosgel®, assessed via Adverse Event (AE) reporting from start of treatment until end of Day 7 4. Percentage of patients with diarrhoea-related complications resulting in hospitalisation, Accident & Emergency department visit, nurse/GP home visit or unscheduled visit to the medical practice from randomisation until end of Day 7 5. Duration (days) of the following from randomisation: 5.1. Nausea 5.2. Vomiting 5.3. High body temperature defined as =38°C 5.4. Abdominal pain All outcomes measured using daily patient diaries throughout the study Previous secondary outcome measures: 1. Percentage of patients with diarrhoea resolved on Day 3 (i.e. first soft or firm stool recorded on Day 0-3) 2. Stool frequency, defined as the average number of stools/day from first intake of treatment to first soft or firm stool 3. Tolerance and safety of Enterosgel®, assessed via Adverse Event (AE) reporting from start of treatment until end of Day 7 4. Percentage of patients with diarrhoea-related complications resulting in hospitalisation, Accident & Emergency department visit, nurse/GP home visit or unscheduled visit to the medical practice from start of treatment until end of Day 7 5. Duration (days) of the following from first intake of treatment: 5.1. Nausea 5.2. Vomiting 5.3. High body temperature defined as =38°C 5.4. Abdominal pain All outcomes meas | — |
Countries
England, United Kingdom
Contacts
Public ContactElena Markaryan
Outcome results
None listed