NCT03356327

Oral Administration of Tannins and Flavonoids in Children With Acute Diarrhea

Completed Phase 4 Last updated 29 November 2017

What this trial tests

Phase 4 trial testing Actitan F in Acute Diarrhea in 60 participants. Completed in 1 November 2017.

Timeline

1 April 2017

Primary endpoint
31 July 2017

1 November 2017

Quick facts

Lead sponsor	Federico II University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 April 2017
Primary completion	31 July 2017
Estimated completion	1 November 2017
Sites	1 location across Italy

Drugs / interventions tested

• Actitan F — full drug profile →
• Standard Oral Rehydration — full drug profile →

Conditions studied

• Acute Diarrhea — all drugs for Acute Diarrhea →

Sponsor

Federico II University

Who can join

Adults 3 Months to 12, any sex, with Acute Diarrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Oral administration of tannins and flavonoids in children with acute diarrhea: a pilot, randomized, control-case study.
   Russo M, Coppola V, Giannetti E, Buonavolontà R, et al · · 2018 · cited 13× · PMID 29866147 · DOI 10.1186/s13052-018-0497-6