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Trial registered on ANZCTR

Registration number

ACTRN12611000641998

Ethics application status

Approved

Date submitted

28/05/2011

Date registered

23/06/2011

Date last updated

23/06/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

Therapeutic effect of Flortec (Registered Trademark) in the treatment of acute gastroenteritis in children

Scientific title

a randomised controlled trial on the effect of oral rehydration solution (ORS) and a new symbiotic formulation called FLORTEC versus oral rehydration solution (ORS) on duration of diarrhea in children with acute gastroenteritis

Secondary ID [1]

nil

Universal Trial Number (UTN)

U1111-1121-5794

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

children with acute gastroenteritis

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

the intervention will consist in a oral administration of standard oral rehydration solution (ORS) (Na + 60 mmol / l, glucose 75-100mOsmol / l, osmolarity 225 - 260 mOsmol / l) taken together with Flortec (no mixed): symbiotic product on the market in the form of 6.0 g packets containing a powder consisting of Lactobacillus paracasei B21060 (2.5x109 CFU), fructo-oligosaccharides (700 mg), glutamine (500 mg) and arabinogalactan (500 mg): 1 packets every 12 hours for 5 days.

Enrolled patients will receive oral rehydration with ORS in the following ways:
- Mild dehydration: 30-50 ml / kg of ORS in the first 4 hours from the diagnosis
- Moderate dehydration: 50-100 ml / kg of ORS in the first 4 hours from the diagnosis

Subsequently receive 10 ml of ORS per kilogram of body weight to prevent dehydration until the end of symptoms.

Intervention code [1]

Treatment: Other

Comparator / control treatment

the control group will receive standard ORS + placebo (taken together, no mixed): a packet identical external appearance and containing the same quantity of powder in appearance and taste very similar to Flortec: 1 packet every 12 hours for 5 days.

Control group

Placebo

Outcomes

Primary outcome [1]

Duration of diarrhea (determined in hours) in children with acute gastroenteritis

Timepoint [1]

from onset of symptoms until the last evacuation of loose stools, followed by 24 hours of regular bowel function (<3 of evacuations / day of formed stool), in a period of 12 months.

Secondary outcome [1]

Rate of patients presenting diarrhea after 48 h of treatment by clinical assessments.

Timepoint [1]

48 hours after intervention commencement

Secondary outcome [2]

Severity of diarrhea evaluated by the number of evacuations per day and the characteristics of the evacuations, according to the following points: 3, liquid, 2, semiliquid; 1, soft; 0, normal.

Timepoint [2]

daily, from baseline until the last evacuation of loose stools

Secondary outcome [3]

Incidence of protracted diarrhea: duration of symptoms> 7 days.

Timepoint [3]

from onset of symptoms until the last evacuation of loose stools

Secondary outcome [4]

Adherence to treatment by questionnaires

Timepoint [4]

at 5 days after intervention commencement

Secondary outcome [5]

other episodes of intestinal infections after treatment by questionnaires

Timepoint [5]

at 2 weeks after intervention stops

Secondary outcome [6]

need of hospitalization by questionnaires

Timepoint [6]

from baseline until the last evacuation of loose stools

Eligibility

Key inclusion criteria

Children aged between 3 and 36 months with acute gastroenteritis defined as increase in the number of bowel movements (> 3 / 24 h) and / or changes in stool consistency referred to family pediatrician's ambulatories; Onset of symptoms <48 hours prior to enrollment. Evidence of mild to moderate dehydration (loss of 3-9% of body weight) to the clinical evaluation: weight loss, depression anterior fontanel, hollows of eyeballs, dryness of mucous membranes, loss of skin elasticity, lowering of respiratory rate, arterial pulse, blood pressure, body temperature, urination, lachrymation

Minimum age

3 Months

Maximum age

36 Months

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Dystrophy (weight/lenght<5 centile), duration of diarrhea > 48 hours, food allergies/ intolerances, assumption of substances that alter the intestinal microflora (probiotics, prebiotics and antibiotics) or have adsorption properties (diosmectite) or modify the intestinal secretion (racecadotril, loperamide), Chronic bowel diseases (celiac disease, inflammatory bowel diseases, cystic fibrosis or other forms of primitive pancreatic insufficiency), gastrointestinal malformations(intestinal atresia, short bowel syndrome, etc.), primary or secondary immunodeficiencies, systemic infections

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

patients will be allocated into one of the 2 groups according to a computer-generated randomization list.
The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated.
Allocation was concealed and was done by numbered sealed opaque envelopes according to a computered randomization list.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

randomization by using block randomization created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Phase 4

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/04/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Department of Pediatrics University of Naples "Federico II"

Address [1]

via Pansini, 5, 80131 Naples

Country [1]

Italy

Primary sponsor type

University

Name

Department of Pediatrics University of Naples "Federico II"

Address

Via Pansini, 5 80131 Naples

Country

Italy

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comitato etico per le attivita' biomediche Universita' degli Studi di Napoli Federico II

Ethics committee address [1]

via Pansini, 5 80131, Naples

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

Approval date [1]

20/05/2009

Ethics approval number [1]

Summary

Brief summary

Therapeutic effect of Flortec (Registered Trademark) in the treatment of acute gastroenteritis in children

Introduction

Acute gastroenteritis is one of the most frequent problems encountered in pediatric clinical practice with a significant epidemiological and economic weight. Only in Italy there are more than 2 million episodes of acute gastroenteritis in children aged <3 years. From the economic point of view the overall cost of an episode of acute gastroenteritis managed at home is approximately 110 Euro for the family inclusive of working days lost by parents, pediatric visits, purchase of medicines and other medical devices. Rehydration by administration of oral rehydration solution (ORS) is the key moment of the treatment of children with acute gastroenteritis. Unfortunately, the ORS is still widely under-used in industrialized countries because of the lack of efficacy on the symptoms of diarrhea. This implicates a large use of drugs and probiotics, prebiotics and symbiotics even if there are no clear evidence of clinical efficacy in the treatment of acute gastroenteritis in children. 
Aim 
To evaluate the efficacy and acceptability of a new symbiotic formulation called FLORTEC in the treatment of acute gastroenteritis in children. 

Methods
Children aged between 3 and 36 months with acute gastroenteritis defined as increase in the number of bowel movements (> 3 / 24 h) and / or changes in stool consistency; Onset of symptoms <48 hours prior to enrollment. Evidence of mild to moderate dehydration.

Exclusion criteria
- Age <3 months > 3 years
- Dystrophy (weight/lenght <5 centile)
- Duration of diarrhea > 48 hours
- food allergies/ intolerances
- Assumption of substances that alter the intestinal microflora (probiotics, prebiotics and
      antibiotics) or have adsorption properties (diosmectite) or modify the
      intestinal secretion (racecadotril, loperamide)
- Chronic bowel diseases (celiac disease, inflammatory bowel diseases, cystic fibrosis or other forms of primitive pancreatic insufficiency)
- Primary or secondary gastrointestinal malformations (intestinal atresia, short bowel syndrome, etc.).
- Primary or secondary immunodeficiencies
- Systemic infections

Intervention
At the enrollment  patients will be randomly allocated into one of the following groups:
- Group 1: standard ORS (Na + 60 mmol / l, glucose 75-100mOsmol / l, osmolarity 225 - 260 mOsmol / l) + Flortec: symbiotic product on the market in the form of 6.0 g packets
containing a powder consisting of Lactobacillus paracasei B21060 (2.5x109 CFU), fructo-oligosaccharides (700 mg), glutamine (500 mg) and arabinogalactan (500 mg):  1 packets 2 time/day for 5 days.

- Group 2: standard ORS +  placebo: a packet identical external appearance and containing the same quantity of powder in appearance and taste very similar to Flortec:  1 packet 2 time/day for 5 days.

Patients will receive prescription  for the self-purchase of medication.

Enrolled patients will receive oral rehydration with ORS in the following ways:
- Mild dehydration: 30-50 ml / kg of ORS in the first 4 hours from diagnosis
- Moderate dehydration: 50-100 ml / kg of ORS in the first 4 hours from diagnosis
Subsequently receive 10 ml of ORS per Kilogram of body weight to prevent dehydration until the end of symptoms.

Outcome indicators
Primary:
Duration of diarrhea determined in hours from onset of symptoms until the last evacuation of loose stools, followed by 24 hours of regular bowel function (<3 of evacuations / day of formed stool).

Secondary:
- Rate of patients presenting diarrhea after 48 h of treatment.
- Severity of diarrhea evaluated by the number of evacuations per day and the characteristics of the evacuations, according to the following points: 3, liquid, 2, semiliquid; 1, soft; 0, normal.
- Incidence of protracted diarrhea: duration of symptoms> 7 days.
- Adherence to treatment
- Need for hospitalization
- Episodes of intestinal infections in the 2 weeks after treatment.

Data Collection
Data were collected by record form.
At the enrollment pediatrician must: verify the inclusion criteria, inform  children’s parents/tutors  about the goals and procedures of the trial, fill out the initial part of the data collection form, deliver the package to the parents/tutors corresponding to the randomization procedure and the data form, plan the next clinical control of the child.

Power study
45 patients are required for each group in order to obtain a power equal to 95% of the study. Type 1 error = 0.05. This number considers a difference in the average duration of diarrhea of 24 hours between the groups (120 hours vs. 96 hours) including a standard deviation of 30 hours. The total number was increased to 100 by estimating a drop out of 10%.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Annalisa Passariello

Address

Department of Pediatrics University of Naples "Federico II", via Pansini 5, 80131, Naples

Country

Italy

Phone

+00 39 0817462680

Fax

[email protected]

Contact person for scientific queries

Name

Annalisa Passariello

Address

Department of Pediatrics University of Naples "Federico II"
Via Pansini,5 80131 Naples

Country

Italy

Phone

+390817462680

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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