The effect of galacto-oligosaccharides (GOS) versus a placebo on defecation parameters and microbiota in healthy children with hard or lumpy stools

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 196

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria, as considered by the researchers:
1. 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
2. Aged 1-6 years (12 to 72 months at the day of inclusion)
3. Hard or firm stools (score of 1 or 2 according to the mBSFS) for more than
50% of the defecations in the past month, as reported by parents and confirmed
by the diary of the first week of the study.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Children who suffer from FC according to the Rome IV criteria: Must include 1
month of at least 2 of the following in infants and children up to 4 years of
age:
o 2 or fewer defecations per week
o History of excessive stool retention
o History of painful or hard bowel movements
o History of large-diameter stools
o Presence of a large fecal mass in the rectum
In toilet-trained children, the following additional criteria may be used:
o At least 1 episode/week of incontinence after the acquisition of toileting
skills
o History of large-diameter stools that may obstruct the toilet
- Children who suffer from GI complaints, 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 allergic to fish
- Use of antibiotics 4 weeks prior to the study run-in period.
- Children on other supplements/ medication that would affect bowel function 1
week prior to the study run-in. This includes e.g. breast milk, fibre
supplements, pre-, pro-, and synbiotics, infant formula, follow on formula or,
young child formula
- Children that participate in another clinical trial.