The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation

Wageningen University and Research

Status: Unknown

Conditions: Functional Constipation

Treatments: Other: dietary intervention with oligosaccharides

Study type: Interventional

Funder types: Other

Identifiers

NCT04282551

NL70126.081.19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 estimated patients

Sex: All

Ages: 1 to 3 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 3 patient groups, including a placebo group

oligosaccharide group 1

Experimental group

Treatment:

Other: dietary intervention with oligosaccharides

oligosaccharide group 2

Experimental group

Treatment:

Other: dietary intervention with oligosaccharides

placebo group

Placebo Comparator group

Treatment:

Other: dietary intervention with oligosaccharides