Gastrointestinal TractFOSTINCT06204978
Evaluation of Gastrointestinal Comfort Following Regular Consumption of Short-chain Fructo-oligosaccharides (10-20 g Per Day) by Children Aged 6-12 Years
A study testing short-chain fructo-oligosaccharides (dose 1), short-chain fructo-oligosaccharides (dose 2) and Baseline in people with Gastrointestinal Tract, run by Tereos at 1 site in France.
Trial summary
The current intake of dietary fiber by children in France and Europe is below established nutritional recommendations. Therefore, promoting fiber consumption from childhood as part of a diversified diet is crucial. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tract
- What is being tested?
- short-chain fructo-oligosaccharides (dose 1), short-chain fructo-oligosaccharides (dose 2) and Baseline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2022to 20 Dec 2023
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children who were willing to participate in the study during school period;
- Have regular stool frequency: less than or equal to 3 stools per day and greater than or equal to 3 stools per week during the week prior to enrollment;
- Wanting to maintain their dietary and physical activity habits during the study;
- Agree to participate and have written informed consent from their parents or legal representatives ;
- A parent or legal representative must have a smartphone compatible with the e-PRO data collection application.
Who cannot join
- Children who had a high fiber intake, as determined by the PNNS-GS2 score during the 7 days prior to inclusion;
- Children who regularly experience gastrointestinal symptoms or have a known ongoing or chronic gastrointestinal condition;
- Children who have any known pathologies, allergies, or food intolerances;
- Children who have received antibiotic treatment in the 2 months prior to inclusion;
- Consumption of any dietary supplement or medication that affects intestinal transit or the gastrointestinal sphere (such as fiber-based supplements, prebiotics, probiotics, symbiotics, osmotic laxatives, or intestinal dressings) within the two weeks prior to inclusion;
- History of gastrointestinal tract surgery (excluding appendectomy);
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- Any medical or surgical history or treatment that could potentially influence the study criteria according to the investigator;
- Children been involved in another study within the last 2 months;
- Girl who have reached menarche and experience dysmenorrhea (abdominal pain and/or changes in bowel movements);
- Parents or legal guardians who are unable to understand, speak, and read French fluently, as well as those who are likely to disregard the protocol and questionnaire completion;
- Legal representative who are unable to provide informed consent due to a court decision or any other condition that may affect their judgment;
- Not affiliated to a health insurance fund through their parents or legal representative.
Trial locations and contacts
1 site in 1 country.
About this study
The current intake of dietary fiber by children in France and Europe is below established nutritional recommendations. Therefore, promoting fiber consumption from childhood as part of a diversified diet is crucial. For over 20 years, the food industry has been using scFOS (short-chain fructo-oligosaccharides), a fiber produced from sugar beet, as an additional source of dietary fiber. This solution can help increase daily fiber intake, meet nutritional recommendations, and provide positive health effects. Although scFOS are commonly used, there has not yet been a prospective study specifically on children aged 6 to 12 to assess gastrointestinal comfort following their regular consumption at dietary doses of 10-20 g per day.
The European Food Safety Authority (EFSA) recommends that all manufacturers document the safety of food ingredients (EFSA, 2021). This is based on Directive 2002/46/EC, which states that substances added to foods, including those intended for specific groups, must be safe and bioavailable. The study aims to assess gastrointestinal comfort and scFOS tolerance in children aged 6 to 12 and is fully compliant with Directive 2002/46/EC and EFSA recommendations.
- Conditions
- Gastrointestinal Tract
- Being tested
- short-chain fructo-oligosaccharides (dose 1), short-chain fructo-oligosaccharides (dose 2), Baseline
- Keywords
- ScFOS, Tolerability, Childrens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short-chain fructo-oligosaccharides (dose 1)Dietary supplement
10 g / day at breakfast during 7 days (Day 8 - Day 14)
short-chain fructo-oligosaccharides (dose 2)Dietary supplement
20 g / day at breakfast during 7 days (Day 8 - Day 14)
BaselineOther
0 g / day of short-chain fructo-oligosaccharides during 7 days (Day 1 - Day 7)
| Study group | Role | What they receive |
|---|---|---|
| scFOS Dose 1 | Other | scFOS 10g Receives: Dietary Supplement: short-chain fructo-oligosaccharides (dose 1); Other: Baseline |
| scFOS Dose 2 | Other | scFOS 20g Receives: Dietary Supplement: short-chain fructo-oligosaccharides (dose 2); Other: Baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal symptoms evolution
Daily gastrointestinal global and invidual symptom scores evaluated on 4-point Likert scales (1:none, 2:mild, 3:moderate, 4:severe) for the following symptoms: bloating, gurgling, flatulence, nausea, vomiting, abdominal pain, heartburn, acid reflux).
Measured: Day 1, Day 2, Day 3,…Day 14
Secondary outcomes (5)
Stool frequency evolution
Number of stools per day
Measured: Day 1, Day 2, Day 3, …Day 14
Bristol Stool scale evolution (Stool consistency)
Daily score (Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating softy stools, and 6 and 7 indicate diarrhoea)
Measured: Day 1, Day 2, Day 3, …Day 14
Adverse events (except gastro-intestinal symptoms) evolution
Number and description of adverse event each day
Measured: Day 1, Day 2, Day 3, …Day 14
Well-being evolution
Daily score (10-point numerical scale;from 1: "felt not at all well, in bad shape" to 10: "felt very well, in great shape");
Measured: Day 1, Day 2, Day 3, …Day 14
Consumption compliance
Number of unused bags of product
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start30 Nov 2022
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal TractStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tereos
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEN Biotech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204978
- Sponsor's protocol ID
- C1712
- Acronym
- FOSTI
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastrointestinal Comfort Following Regular Consumption of Short-chain Fructo-oligosaccharides (10-20 g Per Day) by Children Aged 6-12 Years
- ClinicalTrials.gov ID
- NCT06204978
- Acronym / sponsor ID
- FOSTI / C1712
- Conditions
- Gastrointestinal Tract
- Keywords
- ScFOS, Tolerability, Childrens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TereosIndustry (pharma, biotech, devices)
- Collaborators
- CEN Biotech
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 12 Jan 2024 (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.
The current intake of dietary fiber by children in France and Europe is below established nutritional recommendations. Therefore, promoting fiber consumption from childhood as part of a diversified diet is crucial. For over 20 years, the food industry has been using scFOS (short-chain fructo-oligosaccharides), a fiber produced from sugar beet, as an additional source of dietary fiber. This solution can help increase daily fiber intake, meet nutritional recommendations, and provide positive health effects. Although scFOS are commonly used, there has not yet been a prospective study specifically on children aged 6 to 12 to assess gastrointestinal comfort following their regular consumption at dietary doses of 10-20 g per day.
The European Food Safety Authority (EFSA) recommends that all manufacturers document the safety of food ingredients (EFSA, 2021). This is based on Directive 2002/46/EC, which states that substances added to foods, including those intended for specific groups, must be safe and bioavailable. The study aims to assess gastrointestinal comfort and scFOS tolerance in children aged 6 to 12 and is fully compliant with Directive 2002/46/EC and EFSA recommendations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scFOS Dose 1 | Other | Dietary Supplement: short-chain fructo-oligosaccharides (dose 1), Other: BaselinescFOS 10g |
| scFOS Dose 2 | Other | Dietary Supplement: short-chain fructo-oligosaccharides (dose 2), Other: BaselinescFOS 20g |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children who were willing to participate in the study during school period;
- Have regular stool frequency: less than or equal to 3 stools per day and greater than or equal to 3 stools per week during the week prior to enrollment;
- Wanting to maintain their dietary and physical activity habits during the study;
- Agree to participate and have written informed consent from their parents or legal representatives ;
- A parent or legal representative must have a smartphone compatible with the e-PRO data collection application.
Key exclusion criteria (12 listed)
- Children who had a high fiber intake, as determined by the PNNS-GS2 score during the 7 days prior to inclusion;
- Children who regularly experience gastrointestinal symptoms or have a known ongoing or chronic gastrointestinal condition;
- Children who have any known pathologies, allergies, or food intolerances;
- Children who have received antibiotic treatment in the 2 months prior to inclusion;
- Consumption of any dietary supplement or medication that affects intestinal transit or the gastrointestinal sphere (such as fiber-based supplements, prebiotics, probiotics, symbiotics, osmotic laxatives, or intestinal dressings) within the two weeks prior to inclusion;
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 |
|---|---|---|
| short-chain fructo-oligosaccharides (dose 1)10 g / day at breakfast during 7 days (Day 8 - Day 14) | Dietary supplement | scFOS Dose 1 |
| short-chain fructo-oligosaccharides (dose 2)20 g / day at breakfast during 7 days (Day 8 - Day 14) | Dietary supplement | scFOS Dose 2 |
| Baseline0 g / day of short-chain fructo-oligosaccharides during 7 days (Day 1 - Day 7) | Other | scFOS Dose 1, scFOS Dose 2 |
Primary outcome
Gastrointestinal symptoms evolution
Time frame: Day 1, Day 2, Day 3,…Day 14
Daily gastrointestinal global and invidual symptom scores evaluated on 4-point Likert scales (1:none, 2:mild, 3:moderate, 4:severe) for the following symptoms: bloating, gurgling, flatulence, nausea, vomiting, abdominal pain, heartburn, acid reflux).
5 secondary outcomes
Stool frequency evolution
Time frame: Day 1, Day 2, Day 3, …Day 14
Bristol Stool scale evolution (Stool consistency)
Time frame: Day 1, Day 2, Day 3, …Day 14
Adverse events (except gastro-intestinal symptoms) evolution
Time frame: Day 1, Day 2, Day 3, …Day 14
Well-being evolution
Time frame: Day 1, Day 2, Day 3, …Day 14
Consumption compliance
Time frame: Day 14
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 16 Jan 2024.
- 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 short-chain fructo-oligosaccharides (dose 1), short-chain fructo-oligosaccharides (dose 2) and Baseline in people with Gastrointestinal Tract, run by Tereos 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 5 inclusion and 12 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 16 Jan 2024. 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. 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?
Gastrointestinal symptoms evolution (time frame: Day 1, Day 2, Day 3,…Day 14). 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 16 Jan 2024.