The effect of galacto-oligosaccharides (GOS) or chicory fructo-oligosaccharides (FOS) versus a placebo on bowel habits in children with functional constipation.
- Conditions
- constipationfunctional constipation10017977
- Registration Number
- NL-OMON54813
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 198
In order to be eligible to participate in this study, a subject must meet all
of the following criteria, as considered by a medical doctor:
- Written informed consent obtained from parents or guardians of toddlers
meeting the eligibility criteria and those willing to comply with the
requirements of the study
- Aged 1-6 years (12 to 72 months at the day of inclusion) (at least 25% 1-2
years of age and at least 25% 2-3 years of age)
- Children that meet the following (Rome IV criteria): must include 1 month of
at least 2 of the following in infants up to 4 years of age:
1. 2 or fewer defecations per week
2. History of excessive stool retention
3. History of painful or hard bowel movements
4. History of large-diameter stools
5. Presence of a large fecal mass in the rectum
In toilet-trained children, the following additional criteria may be used:
6. At least 1 episode/week of incontinence after the acquisition of toileting
skills
7. History of large-diameter stools that may obstruct the toilet
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 FC, known structural GI
abnormalities, or previous GI surgery
- Any condition that would make it unsafe for the child to participate. This
can include developmental delays associated with musculoskeletal or neurologic
conditions affecting the gastrointestinal tract. Children with underlying cause
of defecation disorder (for example: Hirschsprung*s disease, spina bifida
occulta, cystic fibrosis, or gastrointestinal malformations).
- 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 lactose intolerant for whom it is expected that low doses of
lactose could lead to diarrhoea or children that are allergic to cow*s milk
(GOS is derived from cow*s milk)
- Children who are allergic to fish
- Use of antibiotics or breast-feeding 4 weeks prior to the study
- Other medicines or food supplements, which can influence defecation and gut
microbiota 1 week prior to the study run-in period. This includes e.g. infant
formula(IF), follow-on formula (FOF) and young child formula (YCF), or products
with labelled pre-and probiotics in the previous week prior to the study run-in
period.
- Children on other supplements/ medication that would affect bowel function
e.g. fibre supplements, and pre-, pro- and synbiotics (excluding escape
medication during the trial as mentioned in chapter 3 and 5.3) for the past
week.
- Children that participate in another clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure will be change in stool consistency. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes includes stool frequency and stool consistency in number of<br /><br>cases (%). </p><br>