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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.
Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.
Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai, China
Stool consistency
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)
Time frame: 4 weeks
Stool frequency
Assessed by daily parental reporting.
Time frame: 4 weeks
Stool amount and stool colour
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)
Time frame: 4 weeks
Treatment success
ROME IV criteria still met at the end of the intervention.
Time frame: 4 weeks
Faecal microbiota
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.
Time frame: 4 weeks
Faecal Short Chain Fatty Acids concentration
Change in Short Chain Fatty Acids over a four week period.
Time frame: 4 weeks
Faecal pH
Change in faecal pH over a four week period.
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Time frame: 4 weeks