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GOS Prebiotic Effect in Children Constipation

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ClinicalTrials.gov Identifier: NCT02183766
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Celia Aparecida Valbon Beleli, University of Campinas, Brazil

Tracking Information
First Submitted Date  ICMJE June 26, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date July 8, 2014
Study Start Date  ICMJE April 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
Evidence of constipation improvement after GOS use in children compared to use of placebo. [ Time Frame: within 30 days of GOS use. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GOS Prebiotic Effect in Children Constipation
Official Title  ICMJE Effect of the Prebiotic 4'Galactooligosaccharides in Children and Adolescents With Functional Constipation
Brief Summary Some prebiotics are useful for improving symptoms related to constipation, but clinical trials including infants and older children are scarce. A double-blind, placebo-controlled, crossover clinical trial was conducted to evaluate the effect of galactooligosaccharides (GOS) on functional constipation in children and adolescents. Twenty children aged 4 to 16 years of age, who spontaneously sought medical care at a primary healthcare unit, received 1.7g GOS or placebo (Maltodextrin) treatment for 30 days, followed by a 15-day washout period and a 30-day use of an alternative product. A clinical score was calculated at baseline, at the 15th (D15) and 30th (D30) day of each period, to assess bowel movement frequency, straining/ pain during defecation and stool consistency. Oral anal transit time with activated charcoal was determined at baseline and D30 of each period.
Detailed Description

Constipation is a common symptom in the pediatric clinics. It is usually defined in terms of difficulty of passage of faeces, faecal consistency and frequency of evacuation. A diet containing high amounts in fiber can promote beneficial effects constipation therapy. Beside the fiber, functional foods, such as prebiotics, have been considered useful to regulate bowel movements. Prebiotic is defined as nondigestible food components that affect the host for stimulating selectively growth of potentially beneficial bacteria in the intestines, specially the colon. Nowadays, there are few clinical trials evaluating prebiotic use for relieving constipation symptoms in children. This clinical trial aimed to evaluate the effect of Galactooligossacharides (GOS) on constipated children. The trial consisted of a 75-day period double blind intervention, controlled with placebo and cross over delimitation, with two sequences of evaluation and two treatments, placebo and galactooligossacharides. It included 20 children (4-16 years) with functional constipation defined by the ROMA III criteria. Children have received 6g of GOS or 6g Maltodextrin (placebo), the solution was ingested for 30 days, followed by a washout period of 15 days, and afterwards, 30 more days of GOS or Maltodextrin, alternately with the product ingested in the first 30 days. The study was designed according to crossover delimitation (GOS and Placebo). Eleven patients were evaluated according to the sequence GOS/placebo and nine patients with the sequence Placebo/GOS. A severity score was measured at the beginning, 2nd and 4th week in each experiment. Clinical scores, elaborated for this Trial, were used to evaluate the effect of the products considering: stool frequency, presence of pain/discomfort/effort during evacuation, consistency of stool and loss of appetite or early satiety. Scores were calculated at day zero (D0), 15th day (D15) and 30th day (D30) of the study, in each phase of the "crossover". Oroanal transit evaluation was performed on D0 and D30 of each sequence, by activated charcoal ingestion.

Descriptive analysis trough measures of position and dispersion were realized for numerical variables. ANOVA was used for the analysis of GOS effect. The significance level assumed for the statistical tests was 5%. The GOS presented significant effect compared to placebo, reducing the stool consistency p< 0,0001 and rising the stool frequency, p=0,0014. The value of the oroanal transit time were significant lower in GOS period, p<0,0001. GOS was effective at the improvement of mild constipation symptoms and may represent an alternative option for the therapy of this condition.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Constipation
Intervention  ICMJE
  • Dietary Supplement: Galactooligosaccharide prebiotic
    6 mL once a day
  • Drug: Maltodextrin
    6 mL once a day
    Other Name: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Maltodextrin
    6 mL once a day diluted in juice during 30 days.
    Intervention: Drug: Maltodextrin
  • Active Comparator: Galactooligosaccharide prebiotic
    6 mL once a day diluted in juice during 30 days.
    Intervention: Dietary Supplement: Galactooligosaccharide prebiotic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2014)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Functional constipation defined by Rome III criteria
  • Consent form signed by parent or guardian

Exclusion Criteria:

  • Patients with systemic, genetic or neurological diseases.
  • Lactose intolerance
  • Laxative use
  • Probiotic use
  • Antibiotic use during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02183766
Other Study ID Numbers  ICMJE 366/2009
0280.0.146.000-09 ( Other Identifier: CAAE )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celia Aparecida Valbon Beleli, University of Campinas, Brazil
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Celia Beleli, Master University of Campinas
PRS Account University of Campinas, Brazil
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP