Effect of a bioactive solution on the duration of diarrhoea in adult and paediatric patients

Not Applicable

Completed

• Conditions: Acute diarrhoea (for less than 48 hours); Digestive System; Diarrhoea

• Registration Number: ISRCTN57765025
• Lead Sponsor: iveLeaf Inc

Brief Summary

2015 Results article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4451028/ results (added 05/03/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-12-07
• Study Start: 2015-01-21
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

1. 5–80 years old
2. Diarrhoea for less than 48 hours

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. Defecation urgency, ranked from 0 (none) to 10 (extreme) at the various time intervals by patients (adults) and caregivers (for children)<br> 2. Bloating or gas, ranked from 0 (none) to 10 (extreme) at the various time intervals by patients (adults) and caregivers (for children)<br> 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<br>