Constipation - FunctionalVEGY-DOWN(A)NCT04028258
Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation
A study of Constipation - Functional, run by Laboratorios Ordesa at 3 sites in Spain.
Trial summary
Once the patients who are candidates to enter the study are identified, the patients will be randomly be assigned to two groups, according to the sequence: Group A: study product+wash out+control product Group B: control product+wash out+study product Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Constipation - Functional
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesSpain
- Study dates
- 13 Feb 2018to Dec 2020
- Phase
- Interventional
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys and girls aged 3 to 12
- Diagnosis of functional constipation according to Rome IV criteria
Who cannot join
- Regular use of a dietary fiber supplement, prebiotics or probiotics in the previous 30 days, or who would have been taking bulk-forming agents or laxatives in the 2 weeks prior to the study
- Use of medications that cause constipation
- Children with organic constipation such as Hirschsprung's disease, cerebral paralysis, anorectal and spinal cord abnormalities and metabolic diseases.
- Patients who are not likely to complete follow-up
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Centro de Salud Perpetuo Socorro
Huesca, Aragon, 22006
Jorge Fuertes, MD, 974 225 450
- Recruiting
Centro de Salud Isabel II
Santander, Cantabria, 39002
Maria Rosa Pardo, 942218161
- Recruiting
Centro de Salud Amparo Poch
Zaragoza, Aragon, 50018
Isabel Lostal, MD, 976 547 499
About this study
Official title: Randomized, Controlled, Crossover, Double-blind Clinical Trial on the Effect of a Mixture of Plant-based Fibers and Carbohydrates on Intestinal Transit in Children Aged 3 to 12 Diagnosed With Functional Constipation
Once the patients who are candidates to enter the study are identified, the patients will be randomly be assigned to two groups, according to the sequence:
- Group A: study product+wash out+control product
- Group B: control product+wash out+study product
Read the detailed description
All patients will be given guidelines for adopting dietary habits and healthy lifestyles to achieve a regular and physiological depositional rhythm and will be given a study supplement and a control supplement, alternatively, for 2 time periods of 3 weeks separated by 2 weeks of wash out.
- Supplement under study: mixture of food fibers of plant origin, in a proportion that contributes 75% soluble fiber / 25% insoluble fiber.
- Control: Placebo supplement: maltodextrin and plum flakes
- Conditions
- Constipation - Functional
- Being tested
- Mixture of fibers + Placebo, Placebo + Mixture of fibers
- Keywords
- Constipation, Fiber
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixture of fibers + PlaceboDietary supplement
Study product: mixture of plant-based food fibers (3 weeks) + wash out (2 weeks) + placebo control : plum flakes + maltodextrin (3 weeks)
Placebo + Mixture of fibersDietary supplement
Placebo control: plum flakes + maltodextrin (3 weeks) + wash out (2 weeks) + study product: mixture of plant-based food fibers (3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Group A: study+wash out+control | Other | Study product (3 weeks) + wash out (2 weeks) + control product (3 weeks) Receives: Dietary Supplement: Mixture of fibers + Placebo |
| Group B: control+wash out+study | Other | Control product (3 weeks) + wash out (2 weeks) + study product (3 weeks) Receives: Dietary Supplement: Placebo + Mixture of fibers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of clinical change obtained from the difference between the initial value and the final value for a combined score of the frequency of passage of faeces, pain to defecation, consistency of stool.
Combined score between this parameters
Measured: From baseline to 8 weeks
Secondary outcomes (8)
Consistency of stool according to Bristol Stool Form Scale
Valuation of stool characteristics (Bristol scale): 7 types of consistency, where type 1 is the hardest consistency.
Measured: From baseline to 8 weeks
Frequency of stool
Equal to or more than 3 times/week, 1-2 times/week, less than 1 time/week
Measured: From baseline to 8 weeks
Change in stool weight
Increase equal to or greater than 50%, increase by 50 - 15%, increase less than 15%
Measured: From baseline to 8 weeks
Gastrointestinal symptoms related to the constipation
Record in the patient's dairy all the gastrointestinal symptoms during the study
Measured: From baseline to 8 weeks
Adherence record to the complement intake (Moriski Green test)
4 questions to the patient about treatment adherence.Patients who follow treatment are considered to be those who answer NO to the four questions and not to those who answer YES to one or more.
Measured: At 8 weeks
Patient anthropometric measures: weight
Anthropometric records: weight (Kg)
Measured: Up to 8 weeks
Patient anthropometric measures: size
Anthropometric records: size (cm)
Measured: Up to 8 weeks
Patient anthropometric measures: waist perimeter
Waist perimeter (cm)
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start13 Feb 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerardo Rodríguez, MD, Principal investigator, Instituto de Investigación Sanitaria Aragón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028258
- Sponsor's protocol ID
- VEGY-DOWN (A)-05-17
- Acronym
- VEGY-DOWN(A)
- Status last verified
- Mar 2020
- First submitted
- 15 Jul 2019
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Crossover, Double-blind Clinical Trial on the Effect of a Mixture of Plant-based Fibers and Carbohydrates on Intestinal Transit in Children Aged 3 to 12 Diagnosed With Functional Constipation
- ClinicalTrials.gov ID
- NCT04028258
- Acronym / sponsor ID
- VEGY-DOWN(A) / VEGY-DOWN (A)-05-17
- Conditions
- Constipation - Functional
- Keywords
- Constipation, Fiber
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Jul 2019 (actual)
- 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.
Once the patients who are candidates to enter the study are identified, the patients will be randomly be assigned to two groups, according to the sequence:
- Group A: study product+wash out+control product
- Group B: control product+wash out+study product
Detailed description
All patients will be given guidelines for adopting dietary habits and healthy lifestyles to achieve a regular and physiological depositional rhythm and will be given a study supplement and a control supplement, alternatively, for 2 time periods of 3 weeks separated by 2 weeks of wash out.
- Supplement under study: mixture of food fibers of plant origin, in a proportion that contributes 75% soluble fiber / 25% insoluble fiber.
- Control: Placebo supplement: maltodextrin and plum flakes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: study+wash out+control | Other | Dietary Supplement: Mixture of fibers + PlaceboStudy product (3 weeks) + wash out (2 weeks) + control product (3 weeks) |
| Group B: control+wash out+study | Other | Dietary Supplement: Placebo + Mixture of fibersControl product (3 weeks) + wash out (2 weeks) + study product (3 weeks) |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Boys and girls aged 3 to 12
- Diagnosis of functional constipation according to Rome IV criteria
Key exclusion criteria (4 listed)
- Regular use of a dietary fiber supplement, prebiotics or probiotics in the previous 30 days, or who would have been taking bulk-forming agents or laxatives in the 2 weeks prior to the study
- Use of medications that cause constipation
- Children with organic constipation such as Hirschsprung's disease, cerebral paralysis, anorectal and spinal cord abnormalities and metabolic diseases.
- Patients who are not likely to complete follow-up
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 |
|---|---|---|
| Mixture of fibers + PlaceboStudy product: mixture of plant-based food fibers (3 weeks) + wash out (2 weeks) + placebo control : plum flakes + maltodextrin (3 weeks) | Dietary supplement | Group A: study+wash out+control |
| Placebo + Mixture of fibersPlacebo control: plum flakes + maltodextrin (3 weeks) + wash out (2 weeks) + study product: mixture of plant-based food fibers (3 weeks) | Dietary supplement | Group B: control+wash out+study |
Primary outcome
Percentage of clinical change obtained from the difference between the initial value and the final value for a combined score of the frequency of passage of faeces, pain to defecation, consistency of stool.
Time frame: From baseline to 8 weeks
Combined score between this parameters
8 secondary outcomes
Consistency of stool according to Bristol Stool Form Scale
Time frame: From baseline to 8 weeks
Frequency of stool
Time frame: From baseline to 8 weeks
Change in stool weight
Time frame: From baseline to 8 weeks
Gastrointestinal symptoms related to the constipation
Time frame: From baseline to 8 weeks
Adherence record to the complement intake (Moriski Green test)
Time frame: At 8 weeks
Patient anthropometric measures: weight
Time frame: Up to 8 weeks
Patient anthropometric measures: size
Time frame: Up to 8 weeks
Patient anthropometric measures: waist perimeter
Time frame: Up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
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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.
Gerardo Rodríguez, MD principal investigator
Instituto de Investigación Sanitaria Aragón
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Constipation - Functional, run by Laboratorios Ordesa at 3 sites in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roser De Castellar, MD (+34 902105243, Roser.DeCastellar@ordesa.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of clinical change obtained from the difference between the initial value and the final value for a combined score of the frequency of passage of faeces, pain to defecation, consistency of stool. (time frame: From baseline to 8 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 9 Mar 2020.