Clinical trial NCT04295213: The Inside Study II: Oligosaccharides Versus Placebo and Hard Stools
Official title: The Effect of a Oligosaccharides Versus a Placebo on Defecation Parameters in Healthy Children With Hard or Lumpy Stools
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy With Hard and/or Lumpy Stools
Keywords: oligosaccharides
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: FrieslandCampina, Amersfoort, The Netherlands
First posted: 2020-03-04
Enrollment: 196
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel study with two arms of 13 weeks in total per participant
Primary purpose: TREATMENT

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 lumpy stools.

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 understood. But it is likely that harder stools in childhood are linked to among others withholding behaviour of stools and a low fibre intake. As hard stools may precede functional constipation, the aim of the study is to investigate the effect of a prebiotic fiber versus a placebo on defecation parameters in healthy children with hard or lumpy stools. We hypothesize that consumption of a prebiotic fiber results in softer stools.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* aged 1-4 years
* Hard and/or firm stools as scored by a stool questionnaire

Exclusion Criteria:

* 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

Primary outcomes:
measure: Stool consistency
timeFrame: Stool consistency will be measured at different time points during a study period of 13 weeks.
Secondary outcomes:
measure: Stool frequency in number of cases (%)
timeFrame: These outcome measures will be measured at different time point during a study period of 13 weeks.
measure: Stool consistency in number of cases (%)
timeFrame: These outcome measures will be measured at different time point during a study period of 13 weeks.
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University and Research
state: Gelderland
Study officials:
affiliation: Wageningen University and Research
name: Clara Belzer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emma Children's Hospital, UMC Amsterdam
name: Marc Benninga, PhD
role: PRINCIPAL_INVESTIGATOR
References: