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The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation

NCT04282551 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2021-10-12

No results posted yet for this study

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.

Conditions

  • Functional Constipation

Interventions

OTHER

dietary intervention with oligosaccharides

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

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • FrieslandCampina, Amersfoort, The Netherlands

    collaborator UNKNOWN

  • Sensus (Royal Cosun), the Netherlands.

    collaborator UNKNOWN

  • Wageningen University and Research

    lead OTHER

Principal Investigators

  • Clara Belzer, PhD · Wageningen University and Research

  • Marc A Benninga, PhD · Emma Children's Hospital, UMC Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04282551 on ClinicalTrials.gov