The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation (Inside)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Functional Constipation
• Intervention / Treatment: Other: dietary intervention with oligosaccharides

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.

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clara Belzer, PhD; Phone Number: 0031317-483742; Email: clara.belzer@wur.nl
• Study Contact Backup: Name: Carrie A Wegh, MSc

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Recruiting
      • Emma Children's Hospital, UMC Amsterdam
      • Contact: Marc A. Benninga, Prof. MD; Phone Number: 003120-56680000; Email: m.a.benninga@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo group	Other: dietary intervention with oligosaccharides; intervention with oligosaccharide 1 or 2, or placebo, given once a day
EXPERIMENTAL: oligosaccharide group 1	Other: dietary intervention with oligosaccharides; intervention with oligosaccharide 1 or 2, or placebo, given once a day
EXPERIMENTAL: oligosaccharide group 2	Other: dietary intervention with oligosaccharides; intervention with oligosaccharide 1 or 2, or placebo, given once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); FrieslandCampina, Amersfoort, The Netherlands; Sensus (Royal Cosun), the Netherlands.
• Investigators: Principal Investigator: Marc A Benninga, PhD, Emma Children's Hospital, UMC Amsterdam

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 24, 2020
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (ACTUAL): February 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: oligosaccharides
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: NL70126.081.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No