NCT02183766

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2010

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

1.9 years

First QC Date

June 26, 2014

Last Update Submit

July 2, 2014

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

  • Evidence of constipation improvement after GOS use in children compared to use of placebo.

    within 30 days of GOS use.

Study Arms (2)

Maltodextrin

PLACEBO COMPARATOR

6 mL once a day diluted in juice during 30 days.

Drug: Maltodextrin

Galactooligosaccharide prebiotic

ACTIVE COMPARATOR

6 mL once a day diluted in juice during 30 days.

Dietary Supplement: Galactooligosaccharide prebiotic

Interventions

Galactooligosaccharide prebioticDIETARY_SUPPLEMENT

6 mL once a day

Galactooligosaccharide prebiotic
MaltodextrinDRUG

6 mL once a day

Also known as: Placebo
Maltodextrin

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Patients with systemic, genetic or neurological diseases.
  • Lactose intolerance
  • Laxative use
  • Probiotic use
  • Antibiotic use during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Constipation

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Celia Beleli, Master

    University of Campinas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master

Study Record Dates

First Submitted

June 26, 2014

First Posted

July 8, 2014

Study Start

April 1, 2010

Primary Completion

March 1, 2012

Study Completion

July 1, 2013

Last Updated

July 8, 2014

Record last verified: 2014-07