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

NCT06204978 | Completed

• 1 other identifier: C1712
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Tract

Keywords

ScFOS; Tolerability; Childrens

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Stool frequency evolution

  Day 1, Day 2, Day 3, …Day 14

• Bristol Stool scale evolution (Stool consistency)

  Day 1, Day 2, Day 3, …Day 14

• Adverse events (except gastro-intestinal symptoms) evolution

  Day 1, Day 2, Day 3, …Day 14

• Well-being evolution

  Day 1, Day 2, Day 3, …Day 14

• Consumption compliance

  Day 14

Study Arms (2)

scFOS Dose 1

OTHER

scFOS 10g

Dietary Supplement: short-chain fructo-oligosaccharides (dose 1); Other: Baseline

scFOS Dose 2

OTHER

scFOS 20g

Dietary Supplement: short-chain fructo-oligosaccharides (dose 2); Other: Baseline

Interventions

short-chain fructo-oligosaccharides (dose 1) DIETARY_SUPPLEMENT

10 g / day at breakfast during 7 days (Day 8 - Day 14)

scFOS Dose 1

short-chain fructo-oligosaccharides (dose 2) DIETARY_SUPPLEMENT

20 g / day at breakfast during 7 days (Day 8 - Day 14)

scFOS Dose 2

Baseline OTHER

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

scFOS Dose 1; scFOS Dose 2

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Tereos: lead
• CEN Biotech: collaborator

Study Sites (1)

CEN Experimental

Dijon, Burgundy, 21000, France

Location

MeSH Terms

Interventions

BaseLine dental cement

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: November 30, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)