Signs and Symptoms, DigestiveFiber - TICNCT02677090
Fiber Tolerability in Children Aged 3-7 Year
A study testing Dose 1 - Promitor®, Dose 2 - Promitor® and Dose 3 - Promitor® in people with Signs and Symptoms, Digestive, run by Société des Produits Nestlé (SPN) at 1 site in France.
Trial summary
Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years old. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Signs and Symptoms, Digestive
- What is being tested?
- Dose 1 - Promitor®, Dose 2 - Promitor® and Dose 3 - Promitor®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Mar 2016
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children
- Aged between 3 and 7 years old
- Acceptance of the taste of the product
- Having breakfast on daily basis
- Consent and/or assent received according to regulation
- Informed consent of both parents/guardians (in respect with the French regulation)
- Parents/guardians affiliated to a health insurance (in respect with the French regulation)
Who cannot join
- Specific food regimen
- Intolerability or food allergy
- Antibiotic or any medication impacting the gut transit during the 2 weeks before the study
- Chronic gastrointestinal disease
- Gastroenteritis in the 2 weeks preceding the study
- Constipation or diarrhea based on ROMEIII criteria (in average: more than 3 stools per day or less than 3 stools per week)
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- Children and parents expected not to understand and perform the trial correctly (i.e.: troubles in learning and/or speaking)
- Child in a situation which, in the opinion of the principal investigator, could interfere with the optimal participation to the study or constitute a particular risk of non-compliance
- Having participated in another clinical trial for 1 month, or currently participating in a clinical trial
- Under legal protection or deprived from his rights following administrative or judicial decision (in respect with the French regulation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fiber Tolerability In Children Aged 3-7 Year
Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years old.
Read the detailed description
The aim of the trial is to determine, using a dose escalation design, the digestive tolerability of the PROMITOR®given at the doses of 6, then 9 and finally 12 g (corresponding to 4, 6, and 8 g of fibers respectively) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fiber) over one week of intake in children from 3 to 7 years old.
As it is an exploratory study there is no categorization between primary and secondary objectives.
- Conditions
- Signs and Symptoms, Digestive
- Being tested
- Placebo (including Maltodextrin), Dose 1 - Promitor®, Dose 2 - Promitor®, Dose 3 - Promitor®
- Keywords
- Fiber tolerability, Children
- Medical subject headings
- Signs and Symptoms, Digestive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (including Maltodextrin)Drug
Dose 1 - Promitor®Drug
Dose 2 - Promitor®Drug
Dose 3 - Promitor®Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo (including Maltodextrin) |
| Dose 1 - Promitor® | Active comparator | Investigational product Dose 1 Receives: Drug: Dose 1 - Promitor® |
| Dose 2 - Promitor® | Active comparator | Investigational product Dose 2 Receives: Drug: Dose 2 - Promitor® |
| Dose 3 - Promitor® | Active comparator | Investigational product Dose 3 Receives: Drug: Dose 3 - Promitor® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the digestive tolerability of the Investigational Product (abdominal pain) using analog visual scale
Using analog visual scale
Measured: 7 days of intake
Assessment of the digestive tolerability of the Investigational Product (rumbling) using analog visual scale
Using analog visual scale
Measured: 7 days of intake
Assessment of the digestive tolerability of the Investigational Product (bloating) using analog visual scale
Using analog visual scale
Measured: 7 days of intake
Assessment of the digestive tolerability of the Investigational Product (flatulence) using analog visual scale
Using analog visual scale
Measured: 7 days of intake
Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency) using analog visual scale
Using analog visual scale
Measured: 7 days of intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Signs and Symptoms, DigestiveStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677090
- Sponsor's protocol ID
- 15.10.NRC
- Acronym
- Fiber - TIC
- Status last verified
- Jan 2016
- First submitted
- 29 Jan 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiber Tolerability In Children Aged 3-7 Year
- ClinicalTrials.gov ID
- NCT02677090
- Acronym / sponsor ID
- Fiber - TIC / 15.10.NRC
- Conditions
- Signs and Symptoms, Digestive
- Keywords
- Fiber tolerability, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Feb 2016 (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.
Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years old.
Detailed description
The aim of the trial is to determine, using a dose escalation design, the digestive tolerability of the PROMITOR®given at the doses of 6, then 9 and finally 12 g (corresponding to 4, 6, and 8 g of fibers respectively) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fiber) over one week of intake in children from 3 to 7 years old.
As it is an exploratory study there is no categorization between primary and secondary objectives.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo (including Maltodextrin)Placebo |
| Dose 1 - Promitor® | Active comparator | Drug: Dose 1 - Promitor®Investigational product Dose 1 |
| Dose 2 - Promitor® | Active comparator | Drug: Dose 2 - Promitor®Investigational product Dose 2 |
| Dose 3 - Promitor® | Active comparator | Drug: Dose 3 - Promitor®Investigational product Dose 3 |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy children
- Aged between 3 and 7 years old
- Acceptance of the taste of the product
- Having breakfast on daily basis
- Consent and/or assent received according to regulation
Key exclusion criteria (10 listed)
- Specific food regimen
- Intolerability or food allergy
- Antibiotic or any medication impacting the gut transit during the 2 weeks before the study
- Chronic gastrointestinal disease
- Gastroenteritis in the 2 weeks preceding 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 |
|---|---|---|
| Placebo (including Maltodextrin) | Drug | Placebo |
| Dose 1 - Promitor® | Drug | Dose 1 - Promitor® |
| Dose 2 - Promitor® | Drug | Dose 2 - Promitor® |
| Dose 3 - Promitor® | Drug | Dose 3 - Promitor® |
Primary outcome
Assessment of the digestive tolerability of the Investigational Product (abdominal pain) using analog visual scale
Time frame: 7 days of intake
Using analog visual scale
Assessment of the digestive tolerability of the Investigational Product (rumbling) using analog visual scale
Time frame: 7 days of intake
Using analog visual scale
Assessment of the digestive tolerability of the Investigational Product (bloating) using analog visual scale
Time frame: 7 days of intake
Using analog visual scale
Assessment of the digestive tolerability of the Investigational Product (flatulence) using analog visual scale
Time frame: 7 days of intake
Using analog visual scale
Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency) using analog visual scale
Time frame: 7 days of intake
Using analog visual scale
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 10 Mar 2016.
- Individual participant dataSharing planned: No
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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.
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 study testing Dose 1 - Promitor®, Dose 2 - Promitor® and Dose 3 - Promitor® in people with Signs and Symptoms, Digestive, run by Société des Produits Nestlé (SPN) at 1 site in France.
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 7 inclusion and 10 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 10 Mar 2016. 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 France. 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.
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?
Assessment of the digestive tolerability of the Investigational Product (abdominal pain) using analog visual scale (time frame: 7 days of intake). The study lists 5 primary outcomes in all. 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 10 Mar 2016.