ConstipationPhase 1NCT02183766
GOS Prebiotic Effect in Children Constipation
A Phase 1 study testing Galactooligosaccharide prebiotic and Maltodextrin in people with Constipation, run by University of Campinas, Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Constipation
- What is being tested?
- Galactooligosaccharide prebiotic and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Functional constipation defined by Rome III criteria
- Consent form signed by parent or guardian
Who cannot join
- Patients with systemic, genetic or neurological diseases.
- Lactose intolerance
- Laxative use
- Probiotic use
- Antibiotic use during the study
About this study
Official title: Effect of the Prebiotic 4'Galactooligosaccharides in Children and Adolescents With Functional Constipation
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.
Read the 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.
- Conditions
- Constipation
- Being tested
- Galactooligosaccharide prebiotic, Maltodextrin
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galactooligosaccharide prebioticDietary supplement
6 mL once a day
MaltodextrinDrug
Also called Placebo
6 mL once a day
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | 6 mL once a day diluted in juice during 30 days. Receives: Drug: Maltodextrin |
| Galactooligosaccharide prebiotic | Active comparator | 6 mL once a day diluted in juice during 30 days. Receives: Dietary Supplement: Galactooligosaccharide prebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of constipation improvement after GOS use in children compared to use of placebo.
Measured: within 30 days of GOS use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 2010
- Primary completionMar 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celia Aparecida Valbon Beleli, University of Campinas, Brazil
- Investigators
- Celia Beleli, Master, Principal investigator, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183766
- Sponsor's protocol ID
- 366/2009
- Other IDs
- 0280.0.146.000-09
- Status last verified
- Jul 2014
- First submitted
- 26 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Prebiotic 4'Galactooligosaccharides in Children and Adolescents With Functional Constipation
- ClinicalTrials.gov ID
- NCT02183766
- Acronym / sponsor ID
- 366/2009
- Conditions
- Constipation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Drug: Maltodextrin6 mL once a day diluted in juice during 30 days. |
| Galactooligosaccharide prebiotic | Active comparator | Dietary Supplement: Galactooligosaccharide prebiotic6 mL once a day diluted in juice during 30 days. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Functional constipation defined by Rome III criteria
- Consent form signed by parent or guardian
Key exclusion criteria (5 listed)
- Patients with systemic, genetic or neurological diseases.
- Lactose intolerance
- Laxative use
- Probiotic use
- Antibiotic use during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galactooligosaccharide prebiotic6 mL once a day | Dietary supplement | Galactooligosaccharide prebiotic |
| MaltodextrinAlso: Placebo6 mL once a day | Drug | Maltodextrin |
Primary outcome
Evidence of constipation improvement after GOS use in children compared to use of placebo.
Time frame: within 30 days of GOS use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celia Beleli, Master principal investigator
University of Campinas
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Galactooligosaccharide prebiotic and Maltodextrin in people with Constipation, run by University of Campinas, Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of constipation improvement after GOS use in children compared to use of placebo. (time frame: within 30 days of GOS use.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.