Effectiveness on the clinical outcome of an oral enterovaccine (Colifagina) and evaluation of the role of the Astrovirus in the aetiology of the pathology of acute gastroenteritis in children.? - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001342-13-IT

Enrollment

Registered

2008-05-28

Start date

2008-02-19

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute gastroenteritis in children.? MedDRA version: 9.1 Level: LLT Classification code 10017893 Term: Gastroenteritis astroviral

Interventions

Trade Name: COLIFAGINA S*OS 10FL 6,5ML Pharmaceutical Form: Oral suspension INN or Proposed INN: VACCINO COLIBACILLARE Concentration unit: ml millilitre(s) Concentration type: equal Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged >2 and 37.5C). Informed consent to study given by parents Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients suffering from a present or past neoplastic condition, with chronic renal insufficiency and/or hepatic insufficiency or severe cardiovascular and/or neurological and/or gastrointestinal pathology. Patients with congenital deficit of IgA and/or with congenital immuno-deficiency Patients receiving immunosuppressive therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.Evaluate on an appropriate number of patients the effectiveness of an enterovaccine (Colifagina) administered by mouth and associated to an oral/intravenous rehydration therapy based on polyelettrolitical solutions, in relation to the clinical outcome of the children suffering from acute gastroenteritis.;Secondary Objective: 2.Evaluate, in this area of interest, the etiologic role of the Astrovirus and of the possible co-infections with Rotavirus and faecal Adenovirus. 3.Evaluate if the treatment with Colifagina determines an increase in the production of intestinal secretory IgA and if it may be correlated to a better clinical outcome;Primary end point(s): -Primary End-point: clinical outcome, based on the number of:  inpatient hospital stays  clinical evaluation of the symptoms expressed in VAS (general conditions, hydration status, presence/absence of vomit, presence/absence of abdominal distension, presence/absence of oral feeding, regained hydration by mouth, fever) and of the signs (decrease of the number of evacuations/day; aspect of the stools evaluated according to the Bristol stool scale) in the two treated groups	—

Measure

Time frame

Main Objective: 1.Evaluate on an appropriate number of patients the effectiveness of an enterovaccine (Colifagina) administered by mouth and associated to an oral/intravenous rehydration therapy based on polyelettrolitical solutions, in relation to the clinical outcome of the children suffering from acute gastroenteritis.;Secondary Objective: 2.Evaluate, in this area of interest, the etiologic role of the Astrovirus and of the possible co-infections with Rotavirus and faecal Adenovirus. 3.Evaluate if the treatment with Colifagina determines an increase in the production of intestinal secretory IgA and if it may be correlated to a better clinical outcome;Primary end point(s): -Primary End-point: clinical outcome, based on the number of:  inpatient hospital stays  clinical evaluation of the symptoms expressed in VAS (general conditions, hydration status, presence/absence of vomit, presence/absence of abdominal distension, presence/absence of oral feeding, regained hydration by mouth, fever) and of the signs (decrease of the number of evacuations/day; aspect of the stools evaluated according to the Bristol stool scale) in the two treated groups

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026