Oral Administration of Tannins and Flavonoids in Children With Acute Diarrhea
Condition: Acute Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      The investigators included 60 children (mean age: 3.1yrs, range 0.3-12years) with a diagnosis
      of AG, referred between April and July 2017 to the Department of Translational Medicine,
      section of Pediatric, University of Naples Federico II.

      Patients enrolled were children from 3 months to 12 years old, with a diagnosis of acute
      diarrhea appeared less than 7 days before the admission, capability to oral rehydration, mild
      to moderate dehydration. Patients with diarrhea over 7 days, serious somatic pathology and
      severe dehydration were excluded.

      The study was approved by the Institutional Review Board of the University of Naples
      "Federico II" with the protocol number 25/17. At admission, written informed consent was
      obtained from participants' parents and from all patients older than 10 years. At first
      visit, a medical history was collected by one of the authors and all patients underwent
      clinical evaluation, including body weight and body temperature.

      Frequency of bowel movements, stool consistency measured through the Bristol Stool Form Scale
      (BSFS) and other associated gastrointestinal symptoms, including nausea, vomiting, abdominal
      pain and rectal bleeding, were accurately recorded. The BSFS is the most commonly
      standardized instrument used to rate stool consistency in children. On admission, the degree
      of dehydration was clinically determined for each patient, based on WHO recommendations and
      data were recorded on a scale from 1 to 3 (1 for mild or <5%; 2 for moderate or 5% to 10%; 3
      for severe or 10% and more).

      Participants were randomly divided into two groups: Group 1 was treated with Actitan F and
      standard oral rehydration (SOR) and Group 2 was treated with SOR only ad libitum for 7 days.
      SOR is a reduced osmolarity oral solution (50/60 mmol/L Na), which is the first line therapy
      recommended by ESPGHAN guideline for Acute Diarrhea. Actitan F, instead, was orally
      administrated at dose of 1 sack every 4 hours, maximum 4 sacks/day for 7 days. Caregivers
      were instructed to administer the daily dose after mixing the contents of the sachet with a
      small amount of water. The study products used in this trial were donated by Aboca® Società
      Agricola SpA., Località Aboca, 20, 52037 Sansepolcro (AR) - Italy.

      At home, all parents had to fulfill a daily diary to record number and consistency of stools,
      presence of fever, vomiting and children compliance with the therapy. During the final visit,
      scheduled after 7 days, the interim history was assessed, daily diaries were reviewed and
      discussed, and a physical evaluation was performed.

      Outcomes

      The primary outcome was the duration of diarrhea, defined as the number of stools after 24
      hours of treatment or the time needed to normalize number and consistency of stools (compared
      with the period before the onset of diarrhea). Secondary outcomes were the evaluation of
      vomiting, body weight, possible need of hospitalization, compliance to therapy.
    

Intervention name(s): Actitan F; Standard Oral Rehydration
Intervention type(s): Drug; Drug
Intervention description(s): A molecolar complex of Tannins and Flavonoids used for acute diarrhea in children; Standard oral rehydration as suggested by ESPGHAN guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment