To determine the clinical effect and tolerance of BA in children with functional constipation aged 3-16 years.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure:
Effect on stool frequency at 3 weeks.
Secondary outcome
Secondary outcomes:
- Effect on stool frequency over 3 weeks.
- Effect on stool consistency over 3 weeks.
- Effect on frequency of episodes of faecal incontinence over 3 weeks.
- Effect on pain during defecation over 3 weeks.
- Effect on digestive symptoms (abdominal pain and flatulence) over 3 weeks.
- Effect on adverse effects (nausea, diarrhea and bad taste) over 3 weeks.
- Effect on rate of success defined as three or more bowel movements per week
and less than 1 faecal incontinence episode over the last 2 weeks of product
consumption.
- Effect on rate of responders according to stool frequency at 3 weeks (a
responder will be defined as a subject who has a stool frequency of 3 or more
on the last week of product consumption).
- Effect on intake of Bisacodyl over 3 weeks.
Background summary
Chronic constipation is a common problem in childhood with an estimated
prevalence of 3% in the western world.(1,2) Approximately 100.000 children in
The Netherlands suffer from constipation. Constipation is a debilitating
condition characterized by infrequent painful defecation, fecal incontinence
and abdominal pain. It causes distress to child and family and results in
severe emotional disturbance and family discord. Presently, there is no proper
therapy available, mainly due to lack of pathophysiological insight.
Approximately 50% of the constipated children have a low compliance taking oral
laxatives for prolonged periods, mainly caused by side effects such as
abdominal pain, nausea, diarrhea, flatulence, and bad taste of the different
compounds. Low compliance is probably of major importance with respect to the
low percentage of children cured after 6 months of laxative treatment. We
hypothesize that the compliance increases by taking yoghurt containing
Bifidobacterium animalis DN-173010. If this study indeed shows a significant
better effect of BA compared to placebo, this will change the treatment of
newly diagnosed children with constipation.
Recently, studies have shown that the bifidobacterium animalis strain DN-173010
(BA) significantly decreased colonic transit time in young and elderly healthy
adults.(5-8) A recent randomized double-blind controlled trial in IBS patients
with constipation (<3 bowel movements/week), showed a significant increase, as
compared to control, in stool frequency over the 6-weeks BA consumption.(9) In
a small pilot study in our centre 8 consecutive children with untreated
constipation with a defecation frequency < 3 per week and hard stools were
treated with BA 2 times/day for one month. A normalization of the defecation
frequency and improvement from hard to soft stools were seen in five of them.
In the three other children no improvement was found. None of the children
reported side effects. A multi-centre RCT is now required to assess whether BA
is effective in the treatment of childhood constipation.
Study objective
To determine the clinical effect and tolerance of BA in children with
functional constipation aged 3-16 years.
Study design
Two nation (The Netherlands, Poland) multi-centre double-blind randomized
controlled trial.
Intervention
The BA group will receive 2 times daily a fermented milk containing 125 g BA in
combination with a bowel diary and toilet training. The placebo group will
receive 2 times daily a bottle with a fermented milk in combination with a
bowel diary and toilet training. In case defecation frequency is less than 3
times per week, bisacodyl 5mg two times per week will be given to the patient.
Compliance of treatment will be evaluated by our standardized bowel diary. The
study treatment will last 3 weeks.
Study burden and risks
There is no risk.
Burden could be considered as minimal ( and not different from "conventional
method"):
Clinical evaluation (and assessment of diaries) will be carried out at
enrolment and at 3 weeks ( each evaluation will last 20 minutes). This schedule
of outpatient clinical visits is standard practice in order to enhance
motivation and compliance of children and their parents with therapy.
Nowadays, these evaluations are also performed in standard therapy of
constipated children.
This trial is important to perform in children because it is such an important
pediatric health problem which can lead, if treated not sufficiently, to severe
morbidity. Presently, there is no proper therapy available, mainly due to lack
of pathophysiological insight. Furthermore, approximately 50% of the
constipated children have a low compliance taking oral laxatives for prolonged
periods, mainly caused by side effects such as abdominal pain, nausea,
diarrhea, flatulence, and bad taste of the different compounds. Low compliance
is probably of major importance with respect to the low percentage of children
cured after 6 months of laxative treatment. We hypothesize that the compliance
increases by taking yoghurt containing Bifidobacterium animalis DN-173010. If
this study indeed shows a significant better effect of BA compared to placebo,
this will change the treatment of newly diagnosed children with constipation.
Because of all prior mentioned reasons, we think it is of great importance that
this trial will be performed in children and not in adults.
Route Départementale 128,
91767 Palaiseau Cedex
Frankrijk
Route Départementale 128,
91767 Palaiseau Cedex
Frankrijk
Listed location countries
Age
Inclusion criteria
Children (3 - 16 years of age) with untreated constipation fulfilling the Rome III-criteria: ;1) Defecation frequency < 3/week ;And at least 1 or more of the following criteria:
2) Fecal incontinence > 1 /week
3) Large amount of stools which clog the toilet
4) Painful defecation
5) Withholding behavior
6) Abdominal or rectal fecal impaction upon physical examination
Exclusion criteria
1) Children treated for constipation
2) Mental retardation / metabolic disease (hypothyroidism)
3) Hirschsprung*s disease / spinal anomalies / anorectal pathology
4) Children who underwent gastro-intestinal surgery
5) Children with functional non-retentive fecal incontinence
6) Children with cow's milk allergy
Design
Recruitment
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 | NL14086.018.07 |