Oral Administration of Tannins and Flavonoids in Children With Acute Diarrhea

NCT03356327 | Completed Phase 4

• 1 other identifier: 16/11/2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Diarrhea

Outcome Measures

Primary Outcomes (2)

• effectiveness of a medical device made of Actitan-F in the treatment of acute diarrhea, valuated on the basis of consistency of stools based on Bristol Stool Form

  the effectiveness of a medical device made of Actitan-F, a natural molecular complex of tannins (from Agrimony and Tormentil) and flavonoids (Chamomile), in the treatment of acute gastroenteritis (AG) in children, valuated on the basis of stool consistency

  2 weeks

• effectiveness of a medical device made of Actitan-F in the treatment of acute diarrhea, valuated on the basis of number of stools / day

  he effectiveness of a medical device made of Actitan-F, a natural molecular complex of tannins (from Agrimony and Tormentil) and flavonoids (Chamomile), in the treatment of acute gastroenteritis (AG) in children, valuated on the basis of number of stools/day

  2 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: Actitan F; Drug: Standard Oral Rehydration

Group 2

ACTIVE COMPARATOR

Group 2 consisting of 30 children who received only SOR.

Drug: Standard Oral Rehydration

Interventions

Actitan F DRUG

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

Group 1

Standard Oral Rehydration DRUG

Standard oral rehydration as suggested by ESPGHAN guidelines

Group 1; Group 2

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Marina Russo

Napoli, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 29866147 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 29, 2017
• Study Start: April 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: November 1, 2017
• Last Updated: November 29, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)