The Inside Study II: Oligosaccharides Versus Placebo and Hard Stools

Healthy With Hard and/or Lumpy Stools Clinical Trial

Official title:

The Effect of a Oligosaccharides Versus a Placebo on Defecation Parameters in Healthy Children With Hard or Lumpy Stools

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04295213
• Other study ID #: NL70820.081.19
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: September 2023

Study information

• Verified date: July 2022
• Source: Wageningen University and Research
• Contact: Clara Belzer, PhD
• Phone: 0031317-483 742
• Email: clara.belzer[@]wur.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: September 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy With Hard and/or Lumpy Stools

Intervention

Other:
• oligosaccharides
1 dose a day of oligosaccharides or placebo

Locations

Country	Name	City	State
Netherlands	Wageningen University and Research	Wageningen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University and Research	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), FrieslandCampina, Amersfoort, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.