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The Inside Study II: Oligosaccharides Versus Placebo and Hard Stools

NCT04295213 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2022-07-13

No results posted yet for this study

Summary

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.

Conditions

  • Healthy With Hard and/or Lumpy Stools

Interventions

OTHER

oligosaccharides

1 dose a day of oligosaccharides or placebo

Sponsors & Collaborators

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

    collaborator OTHER

  • FrieslandCampina, Amersfoort, The Netherlands

    collaborator UNKNOWN

  • Wageningen University and Research

    lead OTHER

Principal Investigators

  • Clara Belzer, PhD · Wageningen University and Research

  • Marc 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
Yes

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2023-07-31
Completion
2023-09-30

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 NCT04295213 on ClinicalTrials.gov