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

Primary Purpose

Functional Constipation

Status

Unknown status

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

dietary intervention with oligosaccharides

About this trial

This is an interventional treatment trial for Functional Constipation focused on measuring oligosaccharides

Eligibility Criteria

1 Year - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emma Children's Hospital, UMC AmsterdamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

oligosaccharide group 1

oligosaccharide group 2

placebo group

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Stool frequency in number of cases (%)

Stool frequency - number of times a child has stools a day as reported in a diary.

Stool consistency in number of cases (%)

Stool consistency - % of stools in a certain stool scale score as measured via a 5 point stool scale

Full Information

NCT ID

NCT04282551

First Posted

December 6, 2019

Last Updated

October 11, 2021

Sponsor

Wageningen University and Research

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), FrieslandCampina, Amersfoort, The Netherlands, Sensus (Royal Cosun), the Netherlands.

1. Study Identification

Unique Protocol Identification Number

NCT04282551

Brief Title

The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation

Acronym

Inside

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 24, 2020 (Actual)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wageningen University and Research

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), FrieslandCampina, Amersfoort, The Netherlands, Sensus (Royal Cosun), the Netherlands.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Constipation

Keywords

oligosaccharides

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel study with three arms of 13 weeks in total per participant.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

oligosaccharide group 1

Arm Type

Experimental

Arm Title

oligosaccharide group 2

Arm Type

Experimental

Arm Title

placebo group

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

dietary intervention with oligosaccharides

Intervention Description

intervention with oligosaccharide 1 or 2, or placebo, given once a day

Primary Outcome Measure Information:

Title

Stool consistency

Description

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)

Time Frame

Stool consistency will be measured at different time points during a study period of 13 weeks.

Secondary Outcome Measure Information:

Title

Stool frequency in number of cases (%)

Description

Stool frequency - number of times a child has stools a day as reported in a diary.

Time Frame

These outcome measures will be measured at different time point during a study period of 13 weeks.

Title

Stool consistency in number of cases (%)

Description

Stool consistency - % of stools in a certain stool scale score as measured via a 5 point stool scale

Time Frame

These outcome measures will be measured at different time point during a study period of 13 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clara Belzer, PhD

Phone

0031317-483742

clara.belzer@wur.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Carrie A Wegh, MSc

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clara Belzer, PhD

Organizational Affiliation

Wageningen University and Research

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marc A Benninga, PhD

Organizational Affiliation

Emma Children's Hospital, UMC Amsterdam

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emma Children's Hospital, UMC Amsterdam

City

Amsterdam

State/Province

Noord-Holland

ZIP/Postal Code

1105AZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc A. Benninga, Prof. MD

Phone

003120-56680000

m.a.benninga@amsterdamumc.nl

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation

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