The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.
The fermentation of prebiotic inulin-type fructans leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA). The introduction of solid foods is frequently associated with harder stools which are more difficult to pass and can cause painful defecations. Subsequently, the changes in bowel habits associated with weaning and the introduction of complementary foods could be minimized by the addition of prebiotics to complementary foods and, thus, the transition from milk-feeding to family food could be facilitated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
140
Hospital Universitari Sant Joan de Reus - Magatzem
Reus, Spain
RECRUITINGHospital Universitari Joan XXIII de Tarragona - Almacén general
Tarragona, Spain
RECRUITINGStool consistency
Assessed by the parents in a continuous daily bowel diary over the study period
Time frame: 4 weeks
Stool frequency
Assessed by daily parental reporting
Time frame: 4 weeks
Stool colour
Assessed by the parents in a continuous daily bowel diary over the study period
Time frame: 4 weeks
Stool amount
Assessed by the parents in a continuous daily bowel diary over the study period
Time frame: 4 weeks
Sleep
Change in sleep behavior assessed by parental questionnaire (Brief Infant Sleep Questionnaire) at the beginning and end of the trial
Time frame: 4 weeks
Stool pH
change in stool pH over a four week period
Time frame: 4 weeks
stool short-chain fatty acids
change in amount and relative distribution of short-chain fatty acids in stool over a four week period
Time frame: 4 weeks
Tolerance and acceptability
Tolerance and acceptability of the study products assessed by customized parental questionnaire at the end of the trial
Time frame: 4 weeks
Body weight
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changes in body weight (kg) assessed by an investigator
Time frame: 4 weeks
Body height
changes in body height (m) assessed by an investigator
Time frame: 4 weeks
Faecal Microbiota
Stool samples will be analysed by appropriate molecular biological methods like 16S rRNA gene sequencing to gain insight into the composition of the gut microbiota.
Time frame: 4 weeks