NCT04282551

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 6, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 24, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

2.4 years

First QC Date

December 6, 2019

Last Update Submit

October 11, 2021

Conditions

Functional Constipation

Keywords

oligosaccharides

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 (3)

oligosaccharide group 1

EXPERIMENTAL
Other: dietary intervention with oligosaccharides

oligosaccharide group 2

EXPERIMENTAL
Other: dietary intervention with oligosaccharides

placebo group

PLACEBO COMPARATOR
Other: dietary intervention with oligosaccharides

Interventions

dietary intervention with oligosaccharidesOTHER

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

oligosaccharide group 1oligosaccharide group 2placebo group

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emma Children's Hospital, UMC Amsterdam

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Related Publications (1)

  • Wegh CAM, Schoterman MHC, Vaughan EE, van der Zalm SCC, Smidt H, Belzer C, A Benninga M. Effect of prebiotic oligosaccharides on bowel habit and the gut microbiota in children with functional constipation (Inside study): study protocol for a randomised, placebo-controlled, multi-centre trial. Trials. 2024 Apr 5;25(1):238. doi: 10.1186/s13063-024-08050-8.

    PMID: 38576033DERIVED

MeSH Terms

Interventions

Diet TherapyOligosaccharides

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeuticsPolysaccharidesCarbohydrates

Study Officials

  • Clara Belzer, PhD

    Wageningen University and Research

    PRINCIPAL INVESTIGATOR

  • Marc A Benninga, PhD

    Emma Children's Hospital, UMC Amsterdam

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara Belzer, PhD

CONTACT

0031317-483742clara.belzer@wur.nl

Carrie A Wegh, MSc

CONTACT

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
Model Details: Parallel study with three arms of 13 weeks in total per participant.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 6, 2019

First Posted

February 24, 2020

Study Start

June 24, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)