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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] 262206 0
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 267899 0
Condition category
Condition code
Oral and Gastrointestinal 268049 268049 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 268103 268103 0 0
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] 264607 0
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] 266798 0
Duration of diarrhea (determined in hours) in children with acute gastroenteritis
Timepoint [1] 266798 0
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] 276409 0
Rate of patients presenting diarrhea after 48 h of treatment by clinical assessments.
Timepoint [1] 276409 0
48 hours after intervention commencement
Secondary outcome [2] 276410 0
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] 276410 0
daily, from baseline until the last evacuation of loose stools
Secondary outcome [3] 276411 0
Incidence of protracted diarrhea: duration of symptoms> 7 days.
Timepoint [3] 276411 0
from onset of symptoms until the last evacuation of loose stools
Secondary outcome [4] 276412 0
Adherence to treatment by questionnaires
Timepoint [4] 276412 0
at 5 days after intervention commencement
Secondary outcome [5] 276413 0
other episodes of intestinal infections after treatment by questionnaires
Timepoint [5] 276413 0
at 2 weeks after intervention stops
Secondary outcome [6] 276489 0
need of hospitalization by questionnaires
Timepoint [6] 276489 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
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] 3595 0
Italy
State/province [1] 3595 0

Funding & Sponsors
Funding source category [1] 267114 0
University
Name [1] 267114 0
Department of Pediatrics University of Naples "Federico II"
Address [1] 267114 0
via Pansini, 5, 80131 Naples
Country [1] 267114 0
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] 266222 0
None
Name [1] 266222 0
Address [1] 266222 0
Country [1] 266222 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267097 0
Comitato etico per le attivita' biomediche Universita' degli Studi di Napoli Federico II
Ethics committee address [1] 267097 0
via Pansini, 5 80131, Naples
Ethics committee country [1] 267097 0
Italy
Date submitted for ethics approval [1] 267097 0
Approval date [1] 267097 0
20/05/2009
Ethics approval number [1] 267097 0

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 32628 0
Address 32628 0
Country 32628 0
Phone 32628 0
Fax 32628 0
Email 32628 0
Contact person for public queries
Name 15875 0
Annalisa Passariello
Address 15875 0
Department of Pediatrics University of Naples "Federico II", via Pansini 5, 80131, Naples
Country 15875 0
Italy
Phone 15875 0
+00 39 0817462680
Fax 15875 0
Email 15875 0
annalisa.passariello@unina.it
Contact person for scientific queries
Name 6803 0
Annalisa Passariello
Address 6803 0
Department of Pediatrics University of Naples "Federico II"
Via Pansini,5 80131 Naples
Country 6803 0
Italy
Phone 6803 0
+390817462680
Fax 6803 0
Email 6803 0
annalisa.passariello@unina.it

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary