The Inside Study II: Oligosaccharides Versus Placebo and Hard Stools

Wageningen University and Research

Status: Enrolling

Conditions: Healthy With Hard and/or Lumpy Stools

Treatments: Other: oligosaccharides

Study type: Interventional

Funder types: Other

Identifiers

NCT04295213

NL70820.081.19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 estimated patients

Sex: All

Ages: 1 to 3 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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196 participants in 2 patient groups, including a placebo group

oligosaccharide group

Experimental group

Description:

intervention with oligosaccharides, total duration of study is 13 weeks

Treatment:

Other: oligosaccharides

placebo group

Placebo Comparator group

Description:

Placebo comparator, total duration of study is 13 weeks

Treatment:

Other: oligosaccharides