This randomised double-blind placebo-controlled study will investigate the effects of a oligofructose vs a placebo on (change in) stool consistency in healthy children with hard stools. Other parameters to be investigated include (change in) stool…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
harde ontlasting
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be (change in) stool consistency.
Secondary outcome
Secondary outcomes include (change in) stool frequency and stool consistency in
number of cases (%). Tertiary outcomes include gastrointestinal symptoms,
quality of life, and gut microbiome outcomes.
Background summary
Stool frequency and consistency change as transition takes place from breast
milk or infant formula to more solid foods. When stools become firm, hard or
lumpy this might be a precursor of functional constipation in childhood. The
cause of harder stools in childhood is incompletely understood. Harder stools
may be linked to low fibre intake, withholding behaviour, due to various
reasons, and the gut microbiota. As both persistent or hard stools can be a
burden for children, this study aims to investigate the effect of chicory
oligofructose (synonym fructooligosaccharides; FOS) versus a placebo on
defecation parameters and intestinal microbiota composition in healthy children
with hard stools aged 1 until 4 years (12 - 48 months). We hypothesise that
consumption of the oligosaccharide, oligofructose, results in softer stools and
changes in the intestinal microbiota.
Study objective
This randomised double-blind placebo-controlled study will investigate the
effects of a oligofructose vs a placebo on (change in) stool consistency in
healthy children with hard stools. Other parameters to be investigated include
(change in) stool frequency, stool consistency in number of cases (%),
gastrointestinal symptoms, quality of life, and gut microbiota composition.
Study design
Parallel study with two arms, placebo-controlled, randomised, double-blind
intervention, with a run-in and wash-out period.
Intervention
Subjects will receive a can of Frutalose® OFP oligofructose or a placebo
Roquette Glucidex Premium IT19 maltodextrin. Cans and scoops will look similar
to ensure blinding. The scoop will be used to add the study product to foods or
drinks for the duration of the intervention period (6 weeks).
Study burden and risks
A significant body of scientific literature can be found which shows that
inulin-type fructans including inulin and fructooligosaccharides (FOS) from
chicory roots are well-tolerated, including infants in human studies. The
United States Food and Drug Administration (US FDA) has confirmed chicory
root-derived inulin-type fructans as a safe ingredient through its formal
review of Sensus* GRAS (Generally Recognized As Safe) documentation. No
allergens were found in Sensus chicory root-derived inulin or FOS at detectable
levels. Inulin/FOS are used in baby and adult food globally i.e., Europe, US
and Asia.
Measurements during this study only involve non-invasive measurements,
including the modified Bristol Stool Form Scale (mBSFS), the Infant Toddler
Quality of Life Questionnaire (ITQOL), faecal sampling and filling out a diary.
Moreover, the prebiotic group might benefit from the intervention, resulting in
a softer stool consistency.
Nassaustraat 36
Venlo 5911 BV
NL
Nassaustraat 36
Venlo 5911 BV
NL
Listed location countries
Age
Inclusion criteria
1. Aged 1-4 years old (12 - 48 months at the day of inclusion).
2. Hard stools (score of 1 or 2 according to the mBSFS) for most (i.e. more
than 50%) of the defecations in the past month, as reported by the parents.
3. Written informed consent was obtained from both parents or guardians of
toddlers meeting the eligibility criteria and those willing to comply with the
requirements of the study.
Exclusion criteria
1. Children diagnosed with functional constipation or have a history of
large-diameter stools that may obstruct the toilet.
2. Children who are diagnosed with gastrointestinal (GI) disorders or known
structural GI abnormalities, or previous GI surgery.
3. Children on a vegetarian/vegan diet.
4. Use of antibiotics or laxatives 4 weeks prior to the study run-in period.
5. Children on other supplements/medication that would affect bowel functioning
one week prior to the study run in. This includes e.g., breast milk, fibre
supplements, pre-, pro-, and synbiotics; also infant-, follow-on-, or young
child formula with prebiotics, probiotics or synbiotics; alternative formula
without pre-, pro-, and synbiotics will be offered.
6. Children that participate in another clinical trial.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL82995.068.22 |