GOS Prebiotic Effect in Children Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Galactooligosaccharide prebiotic; Maltodextrin
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 6 mL once a day; 6 mL once a day
Other intervention name(s): Placebo
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment