difficulty with defecation hard or lumpy stools
Conditions
Interventions
Research subjects will receive either one spoon of 8.5mL of GOS, FOS or a
placebo. For blindness dosage is based on spoon size, which corresponds to
approximately 4,35 g GOS (6.3 g Vivinal® GOS powd
Sponsors
Wageningen Universiteit
Eligibility
Age
No minimum to 11 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria, as considered by the researchers: 1. Written informed consent obtained from parents or guardians of toddlers meeting the eligibility criteria and those willing to comply with the requirements of the study 2. Aged 1-6 years (12 to 72 months at the day of inclusion) 3. Hard or firm stools (score of 1 or 2 according to the mBSFS) for more than 50% of the defecations in the past month, as reported by parents and confirmed by the diary of the first week of the study.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Children who suffer from FC according to the Rome IV criteria: Must include 1 month of at least 2 of the following in infants and children up to 4 years of age: o 2 or fewer defecations per week o History of excessive stool retention o History of painful or hard bowel movements o History of large-diameter stools o Presence of a large fecal mass in the rectum In toilet-trained children, the following additional criteria may be used: o At least 1 episode/week of incontinence after the acquisition of toileting skills o History of large-diameter stools that may obstruct the toilet - Children who suffer from GI complaints, known structural GI abnormalities, or previous GI surgery - Any condition that would make it unsafe for the child to participate. This can include developmental delays associated with musculoskeletal or neurologic conditions affecting the gastrointestinal tract. Children with underlying cause of defecation disorder (for example: Hirschsprung*s disease, spina bifida occulta, cystic fibrosis, or gastrointestinal malformations). - Children with clinically significant cardiac, vascular, liver, pulmonary, psychiatric disorders, severe renal insufficiency, human immunodeficiency virus, acquired immunodeficiency syndrome, hepatitis B or C or known abnormalities of haematology, urinalysis, or blood biochemistry, as checked by the inclusion questionnaire. - Children who are lactose intolerant for whom it is expected that low doses of lactose could lead to diarrhoea or children that are allergic to cow*s milk (GOS is derived from cow*s milk) - Children allergic to fish - Use of antibiotics 4 weeks prior to the study run-in period. - Children on other supplements/ medication that would affect bowel function 1 week prior to the study run-in. This includes e.g. breast milk, fibre supplements, pre-, pro-, and synbiotics, infant formula, follow on formula or, young child formula - Children that participate in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be change in stool consistency. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes includes stool frequency and stool consistency in number of cases (%). | — |
Countries
Netherlands
Outcome results
None listed