In the present randomised double blind controlled study, we will study the effects of a oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with hard or lumpy stools.
Firm, hard or lumpy stools can be problematic for young children and might come as a precursor of functional constipation in childhood. The cause of harder stools in childhood is incompletely understood. But it is likely that harder stools in childhood are linked to among others withholding behaviour of stools and a low fibre intake. As hard stools may precede functional constipation, the aim of the study is to investigate the effect of a prebiotic fiber versus a placebo on defecation parameters in healthy children with hard or lumpy stools. We hypothesize that consumption of a prebiotic fiber results in softer stools.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
196
1 dose a day of oligosaccharides or placebo
Wageningen University and Research
Wageningen, Gelderland, Netherlands
RECRUITINGStool consistency
Change in stool consistency measured by the a stool questionnaire; 5 points stool scale from 1 hard to 5 watery (modified Bristol Stool Form Scale)
Time frame: Stool consistency will be measured at different time points during a study period of 13 weeks.
Stool frequency in number of cases (%)
Stool frequency - number of times a child has stools a day as reported in a diary.by a stool questionnaire
Time frame: These outcome measures will be measured at different time point during a study period of 13 weeks.
Stool consistency in number of cases (%)
Stool consistency - % of stools in a certain stool scale score as measured via a 5 point stool scale
Time frame: These outcome measures will be measured at different time point during a study period of 13 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.