In the present randomised double blind controlled study, the investigators will study the effects of oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with functional constipation.
Functional constipation (FC) in children is a common gastrointestinal (GI) disorder with a worldwide prevalence ranging from 0.7% to 29.6%. Complaints include infrequent bowel movement, painful defecation due to hard and/or large stools, fecal incontinence, and abdominal pain. Although the condition is rarely life-threatening, it strongly impairs quality of life. Oligosaccharides have been shown to relieve constipation symptoms in young adults and elderly. However, sufficient evidence is lacking linking oligosaccharides intake to improve symptoms in children with FC. The investigators hypothesize that oligosaccharides might be able to relieve symptoms of constipation in young children as well, among which softening stools.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
198
intervention with oligosaccharide 1 or 2, or placebo, given once a day
Emma Children's Hospital, UMC Amsterdam
Amsterdam, North Holland, 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.
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.
Carrie A Wegh, MSc
CONTACT
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