Clinical trial NCT06204978: Evaluation of Gastrointestinal Comfort Following Regular Consumption of Short-chain Fructo-oligosaccharides (10-20 g Per Day) by Children Aged 6-12 Years
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tract
Keywords: ScFOS
Tolerability
Childrens
Lead sponsor: Tereos
Sponsor class: INDUSTRY
Collaborators: name: CEN Biotech
First posted: 2024-01-12
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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);
* 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.

Primary outcomes:
measure: Gastrointestinal symptoms evolution
timeFrame: Day 1, Day 2, Day 3,…Day 14
Secondary outcomes:
measure: Stool frequency evolution
timeFrame: Day 1, Day 2, Day 3, …Day 14
measure: Bristol Stool scale evolution (Stool consistency)
timeFrame: Day 1, Day 2, Day 3, …Day 14
measure: Adverse events (except gastro-intestinal symptoms) evolution
timeFrame: Day 1, Day 2, Day 3, …Day 14
measure: Well-being evolution
timeFrame: Day 1, Day 2, Day 3, …Day 14
measure: Consumption compliance
timeFrame: Day 14
Other outcomes:
Locations:
city: Dijon
country: France
facility: CEN Experimental
state: Burgundy
Study officials:
References: