Status:
UNKNOWN
The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation
Lead Sponsor:
Wageningen University and Research
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
FrieslandCampina, Amersfoort, The Netherlands
Conditions:
Functional Constipation
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
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 wi...
Detailed Description
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 defeca...
Eligibility Criteria
Inclusion
- 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
- Aged 1-3 years
- Children that meet the Rome IV criteria for functional constipation
- 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 functional constipation, known structural GI abnormalities, or previous GI surgery
- Any condition that would make it unsafe for the child to participate.
- 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
- Children who are allergic to cow's milk or fish
- Use of antibiotics or other medicines or food supplements, and breast milk-feeding, 4 weeks prior to the study, except for the allowed escape medication
- Children that participate in another clinical trial
Exclusion
Key Trial Info
Start Date :
June 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04282551
Start Date
June 24 2020
End Date
November 1 2022
Last Update
October 12 2021
Active Locations (1)
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1
Emma Children's Hospital, UMC Amsterdam
Amsterdam, North Holland, Netherlands, 1105AZ