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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy With Hard and/or Lumpy Stools
• Intervention / Treatment: Other: oligosaccharides

Detailed Description

Firm, hard or lumpy stools can be problematic for young children and might come as a precursor of functional constipation in childhood. The cause of harder stools in childhood is incompletely understood. But it is likely that harder stools in childhood are linked to among others withholding behaviour of stools and a low fibre intake. As hard stools may precede functional constipation, the aim of the study is to investigate the effect of a prebiotic fiber versus a placebo on defecation parameters in healthy children with hard or lumpy stools. We hypothesize that consumption of a prebiotic fiber results in softer stools.

• Study Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clara Belzer, PhD; Phone Number: 0031317-483 742; Email: clara.belzer@wur.nl
• Study Contact Backup: Name: Carrie Wegh, MSc; Email: carrie.wegh@wur.nl

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WE
      • Recruiting
      • Wageningen University and Research
      • Contact: Carrie A.M. Wegh, MSc; Phone Number: 00316-39267118; Email: carrie.wegh@wur.nl
      • Contact: Clara Belzer, PhD; Email: clara.belzer@wur.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent
• aged 1-4 years
• Hard and/or firm stools as scored by a stool questionnaire

Exclusion Criteria:

• 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 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, as checked by the inclusion questionnaire.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oligosaccharide group; intervention with oligosaccharides, total duration of study is 13 weeks	Other: oligosaccharides; 1 dose a day of oligosaccharides or placebo
Placebo Comparator: placebo group; Placebo comparator, total duration of study is 13 weeks	Other: oligosaccharides; 1 dose a day of oligosaccharides or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool consistency in number of cases (%)	Stool consistency - % of stools in a certain stool scale score as measured via a 5 point stool scale	These outcome measures will be measured at different time point during a study period of 13 weeks.
Stool frequency in number of cases (%)	Stool frequency - number of times a child has stools a day as reported in a diary.by a stool questionnaire	These outcome measures will be measured at different time point during a study period of 13 weeks.

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); FrieslandCampina, Amersfoort, The Netherlands
• Investigators: Principal Investigator: Marc Benninga, PhD, Emma Children's Hospital, UMC Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: oligosaccharides
• Other Study ID Numbers: NL70820.081.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No