<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02183766</url>
  </required_header>
  <id_info>
    <org_study_id>366/2009</org_study_id>
    <secondary_id>0280.0.146.000-09</secondary_id>
    <nct_id>NCT02183766</nct_id>
  </id_info>
  <brief_title>GOS Prebiotic Effect in Children Constipation</brief_title>
  <official_title>Effect of the Prebiotic 4'Galactooligosaccharides in Children and Adolescents With Functional Constipation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campinas, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campinas, Brazil</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Some prebiotics are useful for improving symptoms related to constipation, but clinical&#xD;
      trials including infants and older children are scarce. A double-blind, placebo-controlled,&#xD;
      crossover clinical trial was conducted to evaluate the effect of galactooligosaccharides&#xD;
      (GOS) on functional constipation in children and adolescents. Twenty children aged 4 to 16&#xD;
      years of age, who spontaneously sought medical care at a primary healthcare unit, received&#xD;
      1.7g GOS or placebo (Maltodextrin) treatment for 30 days, followed by a 15-day washout period&#xD;
      and a 30-day use of an alternative product. A clinical score was calculated at baseline, at&#xD;
      the 15th (D15) and 30th (D30) day of each period, to assess bowel movement frequency,&#xD;
      straining/ pain during defecation and stool consistency. Oral anal transit time with&#xD;
      activated charcoal was determined at baseline and D30 of each period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Constipation is a common symptom in the pediatric clinics. It is usually defined in terms of&#xD;
      difficulty of passage of faeces, faecal consistency and frequency of evacuation. A diet&#xD;
      containing high amounts in fiber can promote beneficial effects constipation therapy. Beside&#xD;
      the fiber, functional foods, such as prebiotics, have been considered useful to regulate&#xD;
      bowel movements. Prebiotic is defined as nondigestible food components that affect the host&#xD;
      for stimulating selectively growth of potentially beneficial bacteria in the intestines,&#xD;
      specially the colon. Nowadays, there are few clinical trials evaluating prebiotic use for&#xD;
      relieving constipation symptoms in children. This clinical trial aimed to evaluate the effect&#xD;
      of Galactooligossacharides (GOS) on constipated children. The trial consisted of a 75-day&#xD;
      period double blind intervention, controlled with placebo and cross over delimitation, with&#xD;
      two sequences of evaluation and two treatments, placebo and galactooligossacharides. It&#xD;
      included 20 children (4-16 years) with functional constipation defined by the ROMA III&#xD;
      criteria. Children have received 6g of GOS or 6g Maltodextrin (placebo), the solution was&#xD;
      ingested for 30 days, followed by a washout period of 15 days, and afterwards, 30 more days&#xD;
      of GOS or Maltodextrin, alternately with the product ingested in the first 30 days. The study&#xD;
      was designed according to crossover delimitation (GOS and Placebo). Eleven patients were&#xD;
      evaluated according to the sequence GOS/placebo and nine patients with the sequence&#xD;
      Placebo/GOS. A severity score was measured at the beginning, 2nd and 4th week in each&#xD;
      experiment. Clinical scores, elaborated for this Trial, were used to evaluate the effect of&#xD;
      the products considering: stool frequency, presence of pain/discomfort/effort during&#xD;
      evacuation, consistency of stool and loss of appetite or early satiety. Scores were&#xD;
      calculated at day zero (D0), 15th day (D15) and 30th day (D30) of the study, in each phase of&#xD;
      the &quot;crossover&quot;. Oroanal transit evaluation was performed on D0 and D30 of each sequence, by&#xD;
      activated charcoal ingestion.&#xD;
&#xD;
      Descriptive analysis trough measures of position and dispersion were realized for numerical&#xD;
      variables. ANOVA was used for the analysis of GOS effect. The significance level assumed for&#xD;
      the statistical tests was 5%. The GOS presented significant effect compared to placebo,&#xD;
      reducing the stool consistency p&lt; 0,0001 and rising the stool frequency, p=0,0014. The value&#xD;
      of the oroanal transit time were significant lower in GOS period, p&lt;0,0001. GOS was effective&#xD;
      at the improvement of mild constipation symptoms and may represent an alternative option for&#xD;
      the therapy of this condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2010</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of constipation improvement after GOS use in children compared to use of placebo.</measure>
    <time_frame>within 30 days of GOS use.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>6 mL once a day diluted in juice during 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Galactooligosaccharide prebiotic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>6 mL once a day diluted in juice during 30 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Galactooligosaccharide prebiotic</intervention_name>
    <description>6 mL once a day</description>
    <arm_group_label>Galactooligosaccharide prebiotic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <description>6 mL once a day</description>
    <arm_group_label>Maltodextrin</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Functional constipation defined by Rome III criteria&#xD;
&#xD;
          -  Consent form signed by parent or guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with systemic, genetic or neurological diseases.&#xD;
&#xD;
          -  Lactose intolerance&#xD;
&#xD;
          -  Laxative use&#xD;
&#xD;
          -  Probiotic use&#xD;
&#xD;
          -  Antibiotic use during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celia Beleli, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Campinas</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 2, 2014</last_update_submitted>
  <last_update_submitted_qc>July 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
    <investigator_full_name>Celia Aparecida Valbon Beleli</investigator_full_name>
    <investigator_title>Master</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02183766
org study id: 366/2009
secondary id: 0280.0.146.000-09
nct id: NCT02183766
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Evidence of constipation improvement after GOS use in children compared to use of placebo.
time frame: within 30 days of GOS use.
arm group label: Maltodextrin
arm group type: Placebo Comparator
description: 6 mL once a day diluted in juice during 30 days.
arm group label: Galactooligosaccharide prebiotic
arm group type: Active Comparator
description: 6 mL once a day diluted in juice during 30 days.
intervention type: Dietary Supplement
intervention name: Galactooligosaccharide prebiotic
description: 6 mL once a day
arm group label: Galactooligosaccharide prebiotic
intervention type: Drug
intervention name: Maltodextrin
description: 6 mL once a day
arm group label: Maltodextrin
other name: Placebo
criteria: 
gender: All
minimum age: 4 Years
maximum age: 16 Years
healthy volunteers: No
last name: Celia Beleli, Master
role: Principal Investigator
affiliation: University of Campinas
responsible party type: Principal Investigator
investigator affiliation: University of Campinas, Brazil
investigator full name: Celia Aparecida Valbon Beleli
investigator title: Master
mesh term: Constipation