Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000507583
Ethics application status
Approved
Date submitted
28/10/2014
Date registered
20/05/2015
Date last updated
20/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of oligofructose and inulin in management of chronic nonspecific diarrhoea of childhood – intervention study
Scientific title
Safety and efficacy of a combination of oligofructose and inulin used for chronic nonspecific diarrhoea of childhood when compared with dietary recommendations
Secondary ID [1] 285550 0
Nil known
Universal Trial Number (UTN)
U1111-1163-3812
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic nonspecific diarrhoea of childhood 293368 0
Condition category
Condition code
Oral and Gastrointestinal 293651 293651 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name of intervention: oral supplement of 4 g of inulin enriched with oligofructose (1/1, 2g oligofructose and 2g inulin per day), 1 sachet/day, for 3 months consecutively

Strategy used to monitor adherence to the intervention: sachets return
Intervention code [1] 290495 0
Treatment: Other
Intervention code [2] 291722 0
Treatment: Devices
Comparator / control treatment
Dietary recommendation administrated during the enrollment visit lasting for 45 minutes of face-to-face discussion with pediatrician and parents that could ask questions about the diet: Fruit juice intake minimized, juice with low sucrose and fructose loads; normal caloric intake; not to restrict fiber, and to assure adequate but not overhydration (150ml/kg/d)
Control group
Active

Outcomes
Primary outcome [1] 293464 0
Primary Outcome 1: duration of acute episodes in chronic nonspecific diarrhoea
acute episode: defined as increased stool frequency with changes of stool consistency appreciated according to the Bristol Stool Form Scale, where 1 represents hard stools, 7 indicates watery stools, scores lower than 5 indicate normal stool
duration of acute episodes: is defined as the time from the first loose stool, until at least 12 hours without stool.
Timepoint [1] 293464 0
Timepoint: during intervention and 3 months after intervention stopped
Primary outcome [2] 293465 0
Primary Outcome 2: severity of acute episode in chronic nonspecific diarrhoea evaluated by association of symptoms: vomiting, abdominal pain, constipation; this was marked with Yes/No answers and counted as episodes per period between visits
Timepoint [2] 293465 0
Timepoint: during intervention and 3 months after intervention stoped
Secondary outcome [1] 311103 0
Need for antibiotic use for acute infectious intestinal episodes
Timepoint [1] 311103 0
Timepoint: during intervention and 3months after intervention stoped
Secondary outcome [2] 311640 0
use of antibiotics for any reasons, acute infections during the follow up procedure; the first one refers to intestinal infections and the second one refers to use of antibiotics in general
Timepoint [2] 311640 0
during intervention and 3 months after intervention stoped
Secondary outcome [3] 311641 0
safety and efficiency of the supplement appreciated by a questionnaire completed by parents in terms of treatment efficiency and acceptance (very good/ good/ moderate were the answers options).
Timepoint [3] 311641 0
during intervention and 3 months after intervention stoped
Secondary outcome [4] 314329 0
hospitalization : yes/no answers, duration of hospitalization in days
Timepoint [4] 314329 0
during the follow up procedure

Eligibility
Key inclusion criteria
(1) age 1 to 5 years
(2) at least 5 episodes of diarrhoea in the last 6 months
(3) normal weight and length for age
(4) normal development
Minimum age
1 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
comorbidities of any kind
abnormal nutritional status
acute infections
food allergies
coeliac disease
inflammatory bowel disease
gastrointestinal malformation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis was performed using linear regression, and p values of < 0.05 were considered statistically significant. The descriptive results were emphasized using means (+/-SD) or medians and interquantile ranges. Comparative results were obtained with T-test and Mann-Whitney U-tests. Data were summarize for demographic characteristics , efficacy observation and safety observation using standard deviation statistics. We choose to enroll all patients that had the inclusion criteria through clinical assumption, as a pilot study. Sample size was calculated assuming a proportion of 0.7, with 0.05 precision and a confidence level of 80%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/11/2012
Actual
7/11/2012
Date of last participant enrolment
Anticipated
22/02/2013
Actual
22/02/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment outside Australia
Country [1] 6438 0
Romania
State/province [1] 6438 0
Bucharest

Funding & Sponsors
Funding source category [1] 290153 0
Hospital
Name [1] 290153 0
"Grigore Alexandrescu” Children Emergency Hospital
Country [1] 290153 0
Romania
Primary sponsor type
Hospital
Name
"Grigore Alexandrescu” Children Emergency Hospital
Address
30-32 Iancu de Hunedoara Boulevard, zip code 11743, Bucharest
Country
Romania
Secondary sponsor category [1] 288863 0
None
Name [1] 288863 0
Address [1] 288863 0
Country [1] 288863 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291863 0
Ethics Committee of : "Grigore Alexandrescu” Children Emergency Hospital
Ethics committee address [1] 291863 0
30-32 Iancu de Hunedoara Boulevard, zip code 11743, Bucharest
Ethics committee country [1] 291863 0
Romania
Date submitted for ethics approval [1] 291863 0
Approval date [1] 291863 0
21/09/2012
Ethics approval number [1] 291863 0
12724

Summary
Brief summary
We included patients aged 1 to 5 years old, with at least 5 episodes of diarrhea in the last 6 months fulfilling the criteria of chronic nonspecific diarrhea.
The first 31 patients represented the interventional group, named Group A, and the next 23 patients were in the control group (marked as Group B). Group A received a combination of oligofructose and inulin, 4 g/day, divided in 2 daily oral doses for a period of 3 months, and Group B received only dietary recommendations, according to the current guideline.
The follow up evaluation included 6 medical visits, the first visit was at the time of inclusion, the second was after 2 weeks, the 3rd visit was after another 2 weeks, the 4th and 5th visits were performed every 30 days and the 6th visit took place after 3 months.
The first end point was obtained by comparing clinical efficiency evaluated using gastrointestinal symptoms (vomiting, abdominal pain, constipation) marked with Yes/No answers and counted as episodes per period between visits, number of acute episodes (defined as increased stool frequency with changes of stool consistency) appreciated according to the Bristol Stool Form Scale, where 1 represents hard stools, 7 indicates watery stools, scores lower than 5 indicate normal stool, and the duration of acute episodes is defined as the time from the first loose stool, until at least 12 hours without stool.
The second end point consisted of hospitalization (Yes/No answers and the duration of hospitalization according to medical files), use of antibiotics (Yes/No answers were registered), safety and efficiency appreciated by a questionnaire completed by parents in terms of treatment efficiency and acceptance (very good/ good/ moderate were the answers options).
Trial website
Trial related presentations / publications
1. 47th Annual Meeting of The European Society for Pediatric Gastroenterology, Hepatology and Nutrition 9 - 12 June 2014 Jerusalem, Israel; Chronic nonspecific diarrhea of childhood : Does oligofructose and inuline combination really work? Cristina Becheanu, Iulia Tincu, Roxana Smadeanu, Ana Maria Bradeanu, Gabriela Lesanu; poster presentation; abstract published in JPGN, Volume 58, Supplement 1, June 2014.
2. 2nd International Symposium of Probiotics and Prebiotics in Pediatrics March 7-9, 2014, Antalya,Turkey; Does combination of oligofructose and inuline reduce the severity of chronic nonspecific diarrhea of childhood? Becheanu Cristina, Lesanu Gabriela, Smadeanu Roxana, Tincu Iulia; oral presentation.
Public notes

Contacts
Principal investigator
Name 52326 0
Dr Becheanu Cristina Adriana
Address 52326 0
"Grigore Alexandrescu” Children Emergency Hospital, 30-32 Iancu de Hunedoara Boulevard, zip code 11743, Bucharest
Country 52326 0
Romania
Phone 52326 0
+40213169366
Fax 52326 0
+40213127938
Email 52326 0
cbecheanu@yahoo.com
Contact person for public queries
Name 52327 0
Dr Tincu Iulia Florentina
Address 52327 0
"Grigore Alexandrescu” Children Emergency Hospital, 30-32 Iancu de Hunedoara Boulevard, zip code 11743, Bucharest
Country 52327 0
Romania
Phone 52327 0
+40725535100
Fax 52327 0
+40213127938
Email 52327 0
if_boian@yahoo.com
Contact person for scientific queries
Name 52328 0
Dr Becheanu Cristina Adriana
Address 52328 0
"Grigore Alexandrescu” Children Emergency Hospital, 30-32 Iancu de Hunedoara Boulevard, zip code 11743, Bucharest
Country 52328 0
Romania
Phone 52328 0
+40213169366
Fax 52328 0
+40213127938
Email 52328 0
cbecheanu@yahoo.com

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