In the present randomised double blind controlled study, we will study the effects of GOS or FOS vs a placebo on stool consistency. Other parameters to be investigated include stool frequency, stool consistency in number of cases (%), painful…
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
Functional constipation (FC) in children is a common gastrointestinal (GI)
disorder with a worldwide prevalence ranging from 0.7% to 29.6%. Complaints
include infrequent bowel movement, painful defecation due to hard and/or large
stools, faecal incontinence, and abdominal pain. Although the condition is
rarely life-threatening, it strongly impairs quality of life. Fibres such as
chicory fructo-oligosaccharides (FOS) and galacto-oligosaccharides (GOS) have
been shown to relieve constipation symptoms in young adults and elderly.
However, sufficient evidence is lacking linking additional fibre intake to
improve symptoms in children with FC. We hypothesize that GOS and FOS might be
able to relieve symptoms of constipation in young children as well, among which
softening stools.
Study objective
In the present randomised double blind controlled study, we will study the
effects of GOS or FOS vs a placebo on stool consistency. 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, and the number of times escape medication was used between
groups.
Study design
Parallel study with three 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, which corresponds to 4,35 g GOS (6.3 g Vivinal GOS); 3,70 g FOS (4.0 g
Frutalose®OFP) or 3,35 g maltodextrin (Roquette Glucidex®) per day added to
foods or drinks for 8 weeks.
Study burden and risks
A significant body of scientific literature can be found which shows that
inulin-type fructans including FOS from chicory roots are well-tolerated,
including infants in human studies. United States Food and Drug Administration
(US FDA) have confirmed chicory root derived inulin-type fructans as a safe
ingredient through its formal review of Sensus* GRAS (Generally Recognized As
Safe) documentation. As part of this formal review process, the FDA
specifically reviewed documentation in two areas: chicory FOS production and
whether or not chicory FOS contained allergens found in chicory and other
inulin containing plants. No allergens were found in Sensus chicory root
derived FOS at detectable levels. Daily doses of 0.612 g/100 ml chicory FOS are
used in commercial Dutch and US infant formulae. Frutalose®OFP FOS is used in
baby and adult food globally i.e. Europe, US and Asia.
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 and products for adults. GOS has
been extensively tested in infant and adult studies all over the world [10-12].
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 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
Exclusion criteria
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.
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 |
|---|---|
| ClinicalTrials.gov | NCT04282551 |
| CCMO | NL70126.081.19 |