The Inside Study II: Oligosaccharides Versus Placebo and Hard Stools
The Effect of a Oligosaccharides Versus a Placebo on Defecation Parameters in Healthy Children With Hard or Lumpy Stools
1 other identifier
interventional
196
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 4, 2020
CompletedStudy Start
First participant enrolled
April 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedJuly 13, 2022
July 1, 2022
2.2 years
March 2, 2020
July 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Stool frequency in number of cases (%)
These outcome measures will be measured at different time point during a study period of 13 weeks.
Stool consistency in number of cases (%)
These outcome measures will be measured at different time point during a study period of 13 weeks.
Study Arms (2)
oligosaccharide group
EXPERIMENTALintervention with oligosaccharides, total duration of study is 13 weeks
placebo group
PLACEBO COMPARATORPlacebo comparator, total duration of study is 13 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- aged 1-4 years
- Hard and/or firm stools as scored by a stool questionnaire
You may not qualify if:
- Children that meet the Rome IV criteria for functional constipation
- Children who suffer from any other GI complaints, known structural GI abnormalities, or previous GI surgery
- Any condition that would make it unsafe for the child to participate.
- Children who are allergic to cow's milk or fish
- Use of antibiotics or other medicines or food supplements, and breast milkfeeding, which can influence defecation and gut microbiota 4 weeks prior to the study
- Children that participate in another clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wageningen University and Research
Wageningen, Gelderland, 6708 WE, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clara Belzer, PhD
Wageningen University and Research
- PRINCIPAL INVESTIGATOR
Marc Benninga, PhD
Emma Children's Hospital, UMC Amsterdam
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 2, 2020
First Posted
March 4, 2020
Study Start
April 28, 2021
Primary Completion
July 1, 2023
Study Completion
September 1, 2023
Last Updated
July 13, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share