Oral administration of tannins and flavonoids in children with acute diarrhea: a pilot, randomized, control-case study

Abstract

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).

Keywords: Acute gastroenteritis; Flavonoids; Tannins; Treatment.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Independent Ethics Committee of the “Federico II” University of Naples (reference number: 25/17).

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Flow-chart of the study

Fig. 2

Primary Endpoint: Bowel movements/ day

Fig. 3

Percentage of patients who complained with flavor of MDSM (Group1) and Oral solution (Group2) (p = 0.77)