ConstipationPhase 4SOYFIBERNCT01267370
Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial
A Phase 4 study testing Soy polysaccharide fiber in people with Constipation, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of chronic constipation. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Constipation
- What is being tested?
- Soy polysaccharide fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2002to Oct 2003
- Phase
- Phase 4
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients over two years of age at first consultation and chronic functional constipation were included. Chronic constipation was defined by the occurrence of any of the following, for at least 2 weeks, independently of stool frequency: passage of hard, scybalous, pebble-like or cylindrical cracked stools, straining or painful defecation, passage of large stools that may clog the toilet, or stool frequency less than 3 per week.
Who cannot join
- The exclusion criteria applied were organic constipation, regular use of dietary fiber in the preceding 30 days or drugs causing constipation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Division of Pediatric Gastroenterology UNIFESP
São Paulo, São Paulo, 04039-031
About this study
The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of chronic constipation.
Read the detailed description
The study was performed out at outpatient clinic of Pediatric Gastroenterology at the Federal University of São Paulo (São Paulo, Brazil), located in the southeastern region of Brazil. It is a public referral hospital for pediatric gastroenterology attendance in the Metropolitan area of the São Paulo and in Brazil. In general, the patients go to consultation after a referral from a primary care center.
Study design and sample size The design was a randomized double-blind trial, placebo-controlled study. Sample size was calculated by the formula of comparison of two proportions, using clinical improvement as a primary outcome. It had been previously calculated that a minimum of 14 patients in each group will give a power of 80% to detect a effect size of 50% with significance at the level of 5% (one-sided).
- Conditions
- Constipation
- Being tested
- Soy polysaccharide fiber
- Keywords
- clinical trial, dietary fiber, constipation, children
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy polysaccharide fiberDietary supplement
Also called Soy polysaccharide fiber (Pró-fibra®), Purified soy extract, with no fiber (Soyac®)
Dietary Supplement: Soy polysaccharide fiber First, disimpaction was carried out with phosphate enemas for 1 to 3 days. After the children have been "cleaned out", they received a soy polysaccharide fiber supplement (powder containing 70 g of fiber/100 g) or placebo (purified soy extract, with no fiber) for 6 weeks. Fiber and placebo were given as a standard dose for the different age groups (median of 0,57 g/kg/day) - 2 to 5 years, 10 g/day; 6 to 9 years, 15 g/day; and > 10 years, 20 g/day.
The child that had fecal impaction (a dilated rectum filled with a large amount of stool on rectal examination) during the follow-up was treated by administering phosphate enemas for 1 to 3 consecutive days.
Arms: Soy polysaccharide fiber, purified soy extract, with no fiber
Other Names:
Soy polysaccharide fiber (Pró-fibra®) Purified soy extract, with no fiber (Soyac®)
| Study group | Role | What they receive |
|---|---|---|
| Soy polysaccharide fiber | Active comparator | Dietary fiber for treatment of chronic constipation in children Receives: Dietary Supplement: Soy polysaccharide fiber |
| purified soy extract, with no fiber) | Placebo comparator | blinded control group Receives: Dietary Supplement: Soy polysaccharide fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Frequency of stool passage, paiful defecation, stool consistency
Measured: 6 weeks
Secondary outcomes (1)
total and segmental colonic transit time and fecal weight and moisture
Colonic transit time was evaluated by the technique of Metcalf et al. In brief, a plain abdominal radiograph performed after 24 hours from the last ingestion of 3 sets of 20 distinctive radio-opaque markers taken on 3 consecutive days. In the presence of > 20% of the markers, a further radiography was taken on the 7th day. The colonic segments were delimitated according to Arhan et al. The patients were instructed to collect the 3-day stools separately from the urine. The collected stools were used to determine the fecal weight and moisture.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startJan 2002
- Primary completionDec 2002
- Study completionOct 2003
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Maria Eugênia Farias Almeida Motta, Soraia Tahan, Mauro Batista de Morais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267370
- Sponsor's protocol ID
- FiberCCF-EPM1
- Acronym
- SOYFIBER
- Status last verified
- Oct 2003
- First submitted
- 27 Dec 2010
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial
- ClinicalTrials.gov ID
- NCT01267370
- Acronym / sponsor ID
- SOYFIBER / FiberCCF-EPM1
- Conditions
- Constipation
- Keywords
- clinical trial, dietary fiber, constipation, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Maria Eugênia Farias Almeida Motta, Soraia Tahan, Mauro Batista de Morais
- Study start
- Jan 2002
- Primary completion
- Dec 2002 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 28 Dec 2010 (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.
The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of chronic constipation.
Detailed description
The study was performed out at outpatient clinic of Pediatric Gastroenterology at the Federal University of São Paulo (São Paulo, Brazil), located in the southeastern region of Brazil. It is a public referral hospital for pediatric gastroenterology attendance in the Metropolitan area of the São Paulo and in Brazil. In general, the patients go to consultation after a referral from a primary care center.
Study design and sample size The design was a randomized double-blind trial, placebo-controlled study. Sample size was calculated by the formula of comparison of two proportions, using clinical improvement as a primary outcome. It had been previously calculated that a minimum of 14 patients in each group will give a power of 80% to detect a effect size of 50% with significance at the level of 5% (one-sided).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy polysaccharide fiber | Active comparator | Dietary Supplement: Soy polysaccharide fiberDietary fiber for treatment of chronic constipation in children |
| purified soy extract, with no fiber) | Placebo comparator | Dietary Supplement: Soy polysaccharide fiberblinded control group |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients over two years of age at first consultation and chronic functional constipation were included. Chronic constipation was defined by the occurrence of any of the following, for at least 2 weeks, independently of stool frequency: passage of hard, scybalous, pebble-like or cylindrical cracked stools, straining or painful defecation, passage of large stools that may clog the toilet, or stool frequency less than 3 per week.
Key exclusion criteria (1 listed)
- The exclusion criteria applied were organic constipation, regular use of dietary fiber in the preceding 30 days or drugs causing constipation.
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 |
|---|---|---|
| Soy polysaccharide fiberAlso: Soy polysaccharide fiber (Pró-fibra®), Purified soy extract, with no fiber (Soyac®)Dietary Supplement: Soy polysaccharide fiber First, disimpaction was carried out with phosphate enemas for 1 to 3 days. After the children have been "cleaned out", they received a soy polysaccharide fiber supplement (powder containing 70 g of fiber/100 g) or placebo (purified soy extract, with no fiber) for 6 weeks. Fiber and placebo were given as a standard dose for the different age groups (median of 0,57 g/kg/day) - 2 to 5 years, 10 g/day; 6 to 9 years, 15 g/day; and > 10 years, 20 g/day. The child that had fecal impaction (a dilated rectum filled with a large amount of stool on rectal examination) during the follow-up was treated by administering phosphate enemas for 1 to 3 consecutive days. Arms: Soy polysaccharide fiber, purified soy extract, with no fiber Other Names: Soy polysaccharide fiber (Pró-fibra®) Purified soy extract, with no fiber (Soyac®) | Dietary supplement | Soy polysaccharide fiber, purified soy extract, with no fiber) |
Primary outcome
Clinical response
Time frame: 6 weeks
Frequency of stool passage, paiful defecation, stool consistency
1 secondary outcome
total and segmental colonic transit time and fecal weight and moisture
Time frame: 6 weeks
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 28 Dec 2010.
Related trials for Constipation
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Soy polysaccharide fiber in people with Constipation, run by Federal University of São Paulo at 1 site in 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 1 inclusion and 1 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 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Clinical response (time frame: 6 weeks). 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 28 Dec 2010.