Oral Administration of Tannins and Flavonoids in Children With Acute Diarrhea

NCT ID: NCT03356327

Last Updated: 2017-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2017-11-01

Brief 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.

Conditions

Acute Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Group 1 consisting of 30 children treated with Actitan F and standard oral rehydration (SOR)

Group Type: EXPERIMENTAL

Actitan F

Intervention Type: DRUG

A molecolar complex of Tannins and Flavonoids used for acute diarrhea in children

Standard Oral Rehydration

Intervention Type: DRUG

Standard oral rehydration as suggested by ESPGHAN guidelines

Group 2

Group 2 consisting of 30 children who received only SOR.

Group Type: ACTIVE_COMPARATOR

Standard Oral Rehydration

Intervention Type: DRUG

Standard oral rehydration as suggested by ESPGHAN guidelines

Interventions

Actitan F

A molecolar complex of Tannins and Flavonoids used for acute diarrhea in children

Intervention Type: DRUG

Standard Oral Rehydration

Standard oral rehydration as suggested by ESPGHAN guidelines

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients with diarrhea over 7 days, serious somatic pathology and severe dehydration were excluded.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Annamaria Staiano

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marina Russo

Napoli, , Italy

Countries

Italy

References

Russo M, Coppola V, Giannetti E, Buonavolonta R, Piscitelli A, Staiano A. Oral administration of tannins and flavonoids in children with acute diarrhea: a pilot, randomized, control-case study. Ital J Pediatr. 2018 Jun 4;44(1):64. doi: 10.1186/s13052-018-0497-6.

Reference Type: DERIVED

PMID: 29866147 (View on PubMed)

Other Identifiers

16/11/2017

Identifier Type: -

Identifier Source: org_study_id