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

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 Overview

• Status: Completed
• Conditions: Gastrointestinal Tract
• Intervention / Treatment: Dietary supplement: short-chain fructo-oligosaccharides (dose 1); Other: Baseline; Dietary supplement: short-chain fructo-oligosaccharides (dose 2)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Burgundy
    • Dijon, Burgundy, France, 21000
      • Cen Experimental

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: scFOS Dose 1; scFOS 10g	Dietary supplement: short-chain fructo-oligosaccharides (dose 1); 10 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)
Other: scFOS Dose 2; scFOS 20g	Other: Baseline; 0 g / day of short-chain fructo-oligosaccharides during 7 days (Day 1 - Day 7); Dietary supplement: short-chain fructo-oligosaccharides (dose 2); 20 g / day at breakfast during 7 days (Day 8 - Day 14)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tereos
• Collaborators: CEN Biotech

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Tolerability; Childrens; ScFOS
• Other Study ID Numbers: C1712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No