difficulty passing stool, hard stools constipation
Conditions
Interventions
Subjects will receive a can of Frutalose® OFP oligofructose or a placebo Roquette Glucidex Premium IT19 maltodextrin. Cans and scoops will look similar to ensure blinding. The scoop will be used to ad
Sponsors
Sensus B.V. (Royal Cosun)
Eligibility
Age
No minimum to 11 Years
Inclusion criteria
Inclusion criteria: 1. Aged 1-4 years old (12 - 48 months at the day of inclusion). 2. Hard stools (score of 1 or 2 according to the mBSFS) for most (i.e. more than 50%) of the defecations in the past month, as reported by the parents. 3. Written informed consent was obtained from both parents or guardians of toddlers meeting the eligibility criteria and those willing to comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Children diagnosed with functional constipation or have a history of large-diameter stools that may obstruct the toilet. 2. Children who are diagnosed with gastrointestinal (GI) disorders or known structural GI abnormalities, or previous GI surgery. 3. Children on a vegetarian/vegan diet. 4. Use of antibiotics or laxatives 4 weeks prior to the study run-in period. 5. Children on other supplements/medication that would affect bowel functioning one week prior to the study run in. This includes e.g., breast milk, fibre supplements, pre-, pro-, and synbiotics; also infant-, follow-on-, or young child formula with prebiotics, probiotics or synbiotics; alternative formula without pre-, pro-, and synbiotics will be offered. 6. 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 include (change in) stool frequency and stool consistency innumber of cases (%). Tertiary outcomes include gastrointestinal symptoms, quality of life, and gut microbiome outcomes. | — |
Countries
Netherlands
Contacts
Public ContactR.C. Havermans
Universiteit Maastricht
Outcome results
None listed