The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation

Functional Constipation Clinical Trial

— Inside  

Official title:

The Effect of Oligosaccharides Versus a Placebo on Bowel Habits in Children With Functional Constipation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04282551
• Other study ID #: NL70126.081.19
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2020
• Est. completion date: November 2022

Study information

• Verified date: October 2021
• Source: Wageningen University and Research
• Contact: Clara Belzer, PhD
• Phone: 0031317-483742
• Email: clara.belzer[@]wur.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Other:
• dietary intervention with oligosaccharides
intervention with oligosaccharide 1 or 2, or placebo, given once a day

Locations

Country	Name	City	State
Netherlands	Emma Children's Hospital, UMC Amsterdam	Amsterdam	Noord-Holland

Sponsors (4)

Lead Sponsor	Collaborator
Wageningen University and Research	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), FrieslandCampina, Amersfoort, The Netherlands, Sensus (Royal Cosun), the Netherlands.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool consistency	Change in stool consistency measured by the a stool questionnaire; 5 points stool scale from 1 hard to 5 watery (modified Bristol Stool Form Scale)	Stool consistency will be measured at different time points during a study period of 13 weeks.
Secondary	Stool frequency in number of cases (%)	Stool frequency - number of times a child has stools a day as reported in a diary.	These outcome measures will be measured at different time point during a study period of 13 weeks.
Secondary	Stool consistency in number of cases (%)	Stool consistency - % of stools in a certain stool scale score as measured via a 5 point stool scale	These outcome measures will be measured at different time point during a study period of 13 weeks.