Acute diarrhoea (for less than 48 hours) Digestive System Diarrhoea
Conditions
Interventions
1. Oral rehydration solution and bioactive solution on day 1 and then oral rehydration solution and water (placebo) on day 2
2. Oral rehydration solution and water (placebo) on day 1 a
Sponsors
LiveLeaf Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 5–80 years old 2. Diarrhoea for less than 48 hours
Exclusion criteria
Exclusion criteria: 1. History of uncontrolled emesis 2. Grossly bloody stool 3. Fever 4. Clinical signs of a coexisting acute systemic illness (e.g., meningitis, sepsis or pneumonia) 5. Underlying chronic disease (e.g., heart disease, cystic fibrosis or diabetes) 6. Food allergies or other chronic gastrointestinal diseases 7. Use of probiotic agents in the previous 3 weeks or antibiotics or anti-diarrhoeal medications including over-the-counter and herbal substances in the previous 2 weeks 8. Generalised cachexia 9. Any signs of internal bleeding or drug abuse 10. Any condition, assessed with a standard of care, to cause unnecessary risk if participant given oral rehydration solution alone 11. Unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution to diarrhoea, assessed as the time from ingestion of the solution to when an individual produced a stool with a Bristol Stool Scale ranking of 4 or less. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Defecation urgency, ranked from 0 (none) to 10 (extreme) at the various time intervals by patients (adults) and caregivers (for children) 2. Bloating or gas, ranked from 0 (none) to 10 (extreme) at the various time intervals by patients (adults) and caregivers (for children) 3. Abdominal pain at 30, 60, 90 and 120 minutes after consumption of the solutions on day 1 and day 2; pain was ranked from 0 to 10 on the Visual Analogue Scale | — |
Countries
Nicaragua
Outcome results
None listed