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

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

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).

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