Evaluation of the synbiotic Prodefen GG drops in pediatric patients with acute diarrhea of probable viral etiology
- Conditions
- Acute diarrhea of probable viral etiologyInfections and Infestations
- Registration Number
- ISRCTN10495554
- Lead Sponsor
- ITF RESEARCH PHARMA S.L.U.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 75
1. Children from both sex whose parents/guardians have given their informed consent to participate in the study
2. Children aged 2 years or younger who visited the pediatrician in the primary or the emergency healthcare center, presenting an acute diarrhea episode lasting less than 48 hours, with a probable viral origin
3. Children whose diarrhea will be treated only with diet and/or oral rehydration, on an outpatient basis
4. Children for whom the pediatrician considers treatment with the dietary supplement Prodefen GG drops as an additional treatment measure
1. Children who have presence of any disease that may cause diarrhea, different from an infection, such as inflammatory bowel disease, food allergy, lactose intolerance, etc.
2. Immunocompromised children, children with valve implants, and/or those with a history of infectious endocarditis, due to the risk of bacteremia
3. Children with severe dehydration or malnutrition
4. Children with visible blood in stools
5. Children with current pharmacological treatment for diarrhea
6. Children who have used antibiotics and/or probiotics the previous 7 days
7. Children allergic to milk protein (Prodefen GG drops may contain traces of milk, but do not affect those who are lactose intolerant)
8. Children currently participating in another study
9. Children allergic to any of the components of Prodefen GG drops
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy is measured using the percentage of children who suffer diarrhea according to several definitions, the WHO criteria, the Bristol Stool Form Scale (BSFS) criteria, both WHO and BSFS criteria, and the parents’ opinion regarding more stools per day or more fluid in consistency for at least 1, =2 or =3 consecutive days from day 1 to the end of the study
- Secondary Outcome Measures
Name Time Method