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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03941925

Acronym

CONSTICHILD

Enrollment

100

Registered

2019-05-08

Start date

2019-08-19

Completion date

2021-10-26

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

prebiotic

Brief summary

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

Detailed description

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).

Interventions

DIETARY_SUPPLEMENTPrebiotic fructans

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

DIETARY_SUPPLEMENTNon-prebiotic maltodextrin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 3 Years

Healthy volunteers

Inclusion criteria

1. Diagnosis of functional constipation following ROME4 criteria. 2. Subject is otherwise healthy at the time of pre-examination. 3. Subject is aged 1-3 years at the time of pre-examination. 4. Subject and caretaker are able and willing to follow the study instructions. 5. Subject is suitable for participation in the study according to the investigator/physician/study personnel. 6. Written informed consent is given by parent or legal guardian.

Exclusion criteria

1. No legal guardian's command of any local language. 2. Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc. 3. Other metabolic or renal abnormalities or mental retardation (Child's mental delay). 4. Food allergies or intolerances. 5. Using drugs (e.g. antibiotics) influencing gastrointestinal function (4 weeks before run-in, 6 weeks before intervention). 6. Use of laxatives and labelled pre- and probiotics in the previous 2 weeks before the beginning of run-in (4 weeks before intervention) 7. Subjects who are currently involved or will be involved in another clinical or food study

Design outcomes

Primary

Measure	Time frame	Description
Stool consistency	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

Measure	Time frame	Description
Stool frequency	4 weeks	Assessed by daily parental reporting.
Stool amount and stool colour	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)
Treatment success	4 weeks	ROME IV criteria still met at the end of the intervention.
Faecal microbiota	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.
Faecal Short Chain Fatty Acids concentration	4 weeks	Change in Short Chain Fatty Acids over a four week period.
Faecal pH	4 weeks	Change in faecal pH over a four week period.