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Completed

NCT Number: NCT03941925

Prebiotic Fructans Effect on 1-3 Years Constipated Children's Bowel Habits

The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine

Shanghai, China

About this study

The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children. It is a double-blind, randomized, placebo-controlled trial.This study plans to recruit into the group of 100 participants (at least 80 of them completed) in 2018-2020.The two groups for the study are product group (prebiotic fructans) and control group (placebo maltodextrin).Duration of intervention is 6 weeks, including 2 weeks for run-in and 4 weeks for intervention.Efficacy parameters are stool consistency (assessed with Amsterdam infant stool scale),stool frequency, stool amount and stool color (assessed with Amsterdam infant stool scale, treatment success, tolerance and acceptability).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of functional constipation following ROME4 criteria.
  • Subject is otherwise healthy at the time of pre-examination.
  • Subject is aged 1-3 years at the time of pre-examination.
  • Subject and caretaker are able and willing to follow the study instructions.
  • Subject is suitable for participation in the study according to the investigator/physician/study personnel.
  • Written informed consent is given by parent or legal guardian.

Exclusion criteria

  • No legal guardian's command of any local language.
  • Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc.
  • Other metabolic or renal abnormalities or mental retardation (Child's mental delay).
  • Food allergies or intolerances.
  • Using drugs (e.g. antibiotics) influencing gastrointestinal function (4 weeks before run-in, 6 weeks before intervention).
  • Use of laxatives and labelled pre- and probiotics in the previous 2 weeks before the beginning of run-in (4 weeks before intervention)
  • Subjects who are currently involved or will be involved in another clinical or food study

Treatment and study plan

Prebiotic fructans

Dietary Supplement

Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.

Non-prebiotic maltodextrin

Dietary Supplement

Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.

Primary outcomes

  1. Stool consistency

    Time frame: 4 weeks

    Assessed by the parents in a continuous daily bowel diary over the study period using the Amsterdam Infant Stool Scale (AISS) comprised of a 4-point scale (A: watery, B: soft, C: formed, D: hard)

Secondary outcomes

  1. Stool frequency

    Time frame: 4 weeks

    Assessed by daily parental reporting.

  2. Stool amount and stool colour

    Time frame: 4 weeks

    Assessed by the parents in a continuous daily bowel diary over the study period using the Amsterdam Infant Stool Scale (AISS). Stool amount will be assessed on a 4-point scale (1: smear, 2: up to 25%, 3: 25.50%, 4: >50%, relative to diaper surface). Stool colour will be assessed on a 6-point scale (I: yellow, II: orange, III: green, IV: brown, V: meconium, VI: clay-coloured)

  3. Treatment success

    Time frame: 4 weeks

    ROME IV criteria still met at the end of the intervention.

  4. Faecal microbiota

    Time frame: 4 weeks

    Stool samples will be analyzed by appropriate molecular biological methods like 16S rRNA gene sequencing to gain insight into the composition of the gut microbiota. Furthermore, metabolites like SCFA and other organic acids will be measured with appropriate chromatographic methods.

  5. Faecal Short Chain Fatty Acids concentration

    Time frame: 4 weeks

    Change in Short Chain Fatty Acids over a four week period.

  6. Faecal pH

    Time frame: 4 weeks

    Change in faecal pH over a four week period.

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Beneo GmbH

Registry information

Official study title

Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Fructans on Bowel Habits of Constipated Young Children One to Three Years of Age

Acronym: CONSTICHILD

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 8, 2019
Registry last updated
Aug 12, 2026

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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