Status:
UNKNOWN
The Inside Study II: Oligosaccharides Versus Placebo and Hard Stools
Lead Sponsor:
Wageningen University and Research
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
FrieslandCampina, Amersfoort, The Netherlands
Conditions:
Healthy With Hard and/or Lumpy Stools
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
In the present randomised double blind controlled study, we will study the effects of a oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with hard or lu...
Detailed Description
Firm, hard or lumpy stools can be problematic for young children and might come as a precursor of functional constipation in childhood. The cause of harder stools in childhood is incompletely understo...
Eligibility Criteria
Inclusion
- Written informed consent
- aged 1-4 years
- Hard and/or firm stools as scored by a stool questionnaire
Exclusion
- Children that meet the Rome IV criteria for functional constipation
- Children who suffer from any other GI complaints, 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, as checked by the inclusion questionnaire.
- Children who are allergic to cow's milk or fish
- Use of antibiotics or other medicines or food supplements, and breast milkfeeding, which can influence defecation and gut microbiota 4 weeks prior to the study
- Children that participate in another clinical trial
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT04295213
Start Date
April 28 2021
End Date
September 1 2023
Last Update
July 13 2022
Active Locations (1)
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1
Wageningen University and Research
Wageningen, Gelderland, Netherlands, 6708 WE