Evaluation of Gastrointestinal Comfort Following Regular Consumption of Short-chain Fructo-oligosaccharides (10-20 g Per Day) by Children Aged 6-12 Years

Gastrointestinal Tract Clinical Trial

— FOSTI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06204978
• Other study ID #: C1712
• Status: Completed
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: January 2024
• Source: Tereos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Tract

Intervention

Dietary Supplement:
• short-chain fructo-oligosaccharides (dose 1)
10 g / day at breakfast during 7 days (Day 8 - Day 14)
• short-chain fructo-oligosaccharides (dose 2)
20 g / day at breakfast during 7 days (Day 8 - Day 14)

Other:
• Baseline
0 g / day of short-chain fructo-oligosaccharides during 7 days (Day 1 - Day 7)

Locations

Country	Name	City	State
France	CEN Experimental	Dijon	Burgundy

Sponsors (2)

Lead Sponsor	Collaborator
Tereos	CEN Biotech

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 1, Day 2, Day 3,…Day 14
Secondary	Stool frequency evolution	Number of stools per day	Day 1, Day 2, Day 3, …Day 14
Secondary	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)	Day 1, Day 2, Day 3, …Day 14
Secondary	Adverse events (except gastro-intestinal symptoms) evolution	Number and description of adverse event each day	Day 1, Day 2, Day 3, …Day 14
Secondary	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");	Day 1, Day 2, Day 3, …Day 14
Secondary	Consumption compliance	Number of unused bags of product	Day 14