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Completed

NCT Number: NCT06204978

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

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEN Experimental

Dijon, Burgundy, 21000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

short-chain fructo-oligosaccharides (dose 1)

Dietary Supplement

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

short-chain fructo-oligosaccharides (dose 2)

Dietary Supplement

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

Baseline

Other

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

Primary outcomes

  1. Gastrointestinal symptoms evolution

    Time frame: Day 1, Day 2, Day 3,…Day 14

    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).

Secondary outcomes

  1. Stool frequency evolution

    Time frame: Day 1, Day 2, Day 3, …Day 14

    Number of stools per day

  2. Bristol Stool scale evolution (Stool consistency)

    Time frame: Day 1, Day 2, Day 3, …Day 14

    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)

  3. Adverse events (except gastro-intestinal symptoms) evolution

    Time frame: Day 1, Day 2, Day 3, …Day 14

    Number and description of adverse event each day

  4. Well-being evolution

    Time frame: Day 1, Day 2, Day 3, …Day 14

    Daily score (10-point numerical scale;from 1: "felt not at all well, in bad shape" to 10: "felt very well, in great shape");

  5. Consumption compliance

    Time frame: Day 14

    Number of unused bags of product

Sponsors and collaborators

Lead sponsor

Tereos

Industry

Collaborators

  • CEN Biotech

Registry information

Acronym: FOSTI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2024
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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