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Published on: December 31, 2017
Oral administration of tannins and flavonoids in children with acute diarrhea: a pilot, randomized, control-case
Marina Russo1, Vincenzo Coppola1, Eleonora Giannetti1
1Department of Translational Medical Science, Section of Pediatrics, "Federico II" University of Naples, Via S. Pansini, 5, 80131, Naples, Italy.
Insights
Actitan F, combined with standard oral rehydration, may safely shorten acute gastroenteritis (AG) duration in children. Further research is needed to confirm these promising findings for pediatric diarrhea management.
Area of Science:
- Pediatric Gastroenterology
- Clinical Trials
- Diarrheal Diseases
Background:
- Acute gastroenteritis (AG) is a common pediatric illness causing significant morbidity and mortality.
- Current management relies on rehydration therapy, which doesn't effectively reduce diarrhea duration.
- There's a need for safe, cost-effective interventions to complement oral rehydration therapy.
Purpose of the Study:
- To evaluate the safety and efficacy of Actitan F as an adjunct to standard oral rehydration (SOR) in children with AG.
- To assess the impact of Actitan F on the duration and frequency of diarrhea in pediatric patients.
Main Methods:
- A pilot randomized controlled trial involving 60 children (1-17 years) with mild-moderate AG.
- Two groups were formed: Group 1 received Actitan F with SOR, Group 2 received SOR only.
- Group 1 transitioned to Actitan F alone after 24 hours of combined therapy.
Main Results:
- Actitan F significantly reduced stool frequency within 24 hours (p < 0.0001).
- The median duration of diarrhea was 5 days in the Actitan F group versus 4 days in the SOR-only group (p = 0.48).
- The study indicated a trend towards shorter diarrhea duration with Actitan F, although not statistically significant.
Conclusions:
- Actitan F, when administered with SOR, appears to be a safe and potentially effective treatment for reducing AG duration in children.
- Further clinical studies are warranted to validate these preliminary findings and establish Actitan F's role in pediatric gastroenteritis management.
Background:
AG is the most common cause of pediatric consultations among children between 2 and 5 years of age and it still leads to high mortality and morbidity. Its management is based on rehydration therapy, but this treatment is not effective in reducing duration of diarrhea. For this reason, other safer and less expensive interventions, which could be added to oral rehydration therapy, are of great interest.
Methods:
A pilot, randomized, case-controlled trial was conducted in 60 children affected by AG (< 7 days) with mild-moderate dehydration, according to WHO recommendations, from1 year to 17 years old. Patients were divided into 2 Groups: Group 1 consisting of 30 children treated with Actitan F and standard oral rehydration (SOR); Group 2 consisting of 30 children who received only SOR. Both groups received treatment for seven days, respectively. Patients of Group 1 stopped for their own choice, SOR after the first 24 h and continued only with Actitan F.
Results:
After 24 h of treatment, the median number of stools was 3.5 for Group 1, and 4 for Group 2. In Group 1 the difference between the number of stools at baseline (n = 5) and after 24 h of treatment (n = 3.5) was significant (p < 0.0001). At the end of treatment, the median duration of diarrhea in Group 1 was 5 days, compared with 4 days in the Group 2, this difference was not statically significant (p 0.48).
Conclusions:
Oral administration of Actitan F associated with SOR seems safe and effective treatment in shortening the duration of AG in children. Further studies confirming these data are needed.
Trial Registration:
NCT03356327 (retrospectively registered).
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