Clinical trial NCT04282551: The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation
Official title: The Effect of Oligosaccharides Versus a Placebo on Bowel Habits in Children With Functional Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Constipation
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
name: Sensus (Royal Cosun), the Netherlands.
First posted: 2020-02-24
Enrollment: 198
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel study with three arms of 13 weeks in total per participant.
Primary purpose: TREATMENT

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 with functional constipation.

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 defecation due to hard and/or large stools, fecal incontinence, and abdominal pain. Although the condition is rarely life-threatening, it strongly impairs quality of life. Oligosaccharides have been shown to relieve constipation symptoms in young adults and elderly. However, sufficient evidence is lacking linking oligosaccharides intake to improve symptoms in children with FC. The investigators hypothesize that oligosaccharides might be able to relieve symptoms of constipation in young children as well, among which softening stools.

Eligibility 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
* 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

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: Amsterdam
country: Netherlands
facility: Emma Children's Hospital, UMC Amsterdam
state: Noord-Holland
Study officials:
affiliation: Wageningen University and Research
name: Clara Belzer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emma Children's Hospital, UMC Amsterdam
name: Marc A Benninga, PhD
role: PRINCIPAL_INVESTIGATOR
References: