constipation functional constipation
Conditions
Interventions
Research subjects will receive either one spoon of 8.5mL of GOS, FOS or a
placebo, which corresponds to 4,35 g GOS (6.3 g Vivinal GOS)
3,70 g FOS (4.0 g
Frutalose®OFP) or 3,35 g maltodextrin (Roquette Glucidex®) per day added to
foods or drinks for 8 weeks.
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 a medical doctor: - 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 - Aged 1-6 years (12 to 72 months at the day of inclusion) (at least 25% 1-2 years of age and at least 25% 2-3 years of age) - Children that meet the following (Rome IV criteria): must include 1 month of at least 2 of the following in infants up to 4 years of age: 1. 2 or fewer defecations per week 2. History of excessive stool retention 3. History of painful or hard bowel movements 4. History of large-diameter stools 5. Presence of a large fecal mass in the rectum In toilet-trained children, the following additional criteria may be used: 6. At least 1 episode/week of incontinence after the acquisition of toileting skills 7. History of large-diameter stools that may obstruct the toilet
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 any other GI complaints than FC, 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 who are allergic to fish - Use of antibiotics or breast-feeding 4 weeks prior to the study - Other medicines or food supplements, which can influence defecation and gut microbiota 1 week prior to the study run-in period. This includes e.g. infant formula(IF), follow-on formula (FOF) and young child formula (YCF), or products with labelled pre-and probiotics in the previous week prior to the study run-in period. - Children on other supplements/ medication that would affect bowel function e.g. fibre supplements, and pre-, pro- and synbiotics (excluding escape medication during the trial as mentioned in chapter 3 and 5.3) for the past week. - 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