In the present randomised double blind controlled study, we will study the effects of GOS vs a placebo on stool consistency in children with hard or lumpy stools. Other parameters to be investigated include stool frequency, stool consistency in…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be change in stool consistency.
Secondary outcome
Secondary outcomes includes stool frequency and stool consistency in number of
cases (%).
Background summary
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 withholding behaviour of stools, a low fibre
intake, and the gut microbiota composition. As hard stools may precede
functional constipation, the aim of the study is to investigate the effect of
GOS versus a placebo on defecation parameters and microbiota in healthy
children with hard or lumpy stools, aged 1-6 years. We hypothesize that
consumption of GOS results in softer stools and changes in microbiota.
Study objective
In the present randomised double blind controlled study, we will study the
effects of GOS vs a placebo on stool consistency in children with hard or lumpy
stools. Other parameters to be investigated include stool frequency, stool
consistency in number of cases (%), painful defecation, quality of life of the
child, gastrointestinal symptoms, gut microbiome outcomes, faecal pH, dietary
intake and, if age appropriate abdominal pain.
Study design
Parallel study with two arms of duration one week run-in, 8 week
placebo-controlled randomised double-blind intervention with a 4 week wash-out
afterwards.
Intervention
Research subjects will receive either one spoon of 8.5mL of GOS, FOS or a
placebo. For blindness dosage is based on spoon size, which corresponds to
approximately 4,35 g GOS (6.3 g Vivinal® GOS powder) or 3,35 g maltodextrin
(Roquette Glucidex®) per day added to foods or drinks for 8 weeks.
Study burden and risks
For GOS many studies have been performed to substantiate safety and tolerance.
Vivinal® GOS is used world-wide as an ingredient in standard and premium infant
formula, follow-on formulas, growing up milk young child formulas and products
for adults. GOS has been extensively tested in infant and adult studies all
over the world. Studies in infants showed that consumption of GOS up to
0.8g/100 ml is well-tolerated. Only in subjects with pre-existing allergies in
the Southeast Asian region, a very limited number of Vivinal GOS related
allergic reactions has been reported over the past few years. After completing
extensive scientific research and safety studies, Vivinal GOS received GRAS
approval for use in food and infant food in the USA by the FDA. Furthermore,
the European Union Scientific Committee on Food accepted GOS in infant and
follow-on formulas, and GOS is regulated in the EU Directive 2006/141. Both
chicory FOS and GOS are well-established prebiotics.
Measurements during this study only involve non-invasive measurements,
including filling out of a diary, questionnaires, a dietary assessment, and
faecal sampling. Moreover, the prebiotic group might benefit from the
intervention, resulting in a softer stool consistency.
stippeneng 4
Wageningen 6708 WE
NL
stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
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.
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinicaltrials.gov, NCT04295213 |
| CCMO | NL70820.081.19 |