Status:
COMPLETED
Evaluation of Gastrointestinal Comfort Following Regular Consumption of Short-chain Fructo-oligosaccharides (10-20 g Per Day) by Children Aged 6-12 Years
Lead Sponsor:
Tereos
Collaborating Sponsors:
CEN Biotech
Conditions:
Gastrointestinal Tract
Eligibility:
All Genders
6-12 years
Phase:
NA
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 di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06204978
Start Date
November 30 2022
End Date
December 20 2023
Last Update
January 16 2024
Active Locations (1)
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1
CEN Experimental
Dijon, Burgundy, France, 21000