Is Bifidobacterium breve effective in the treatment of childhood constipation?

Approximately 100.000 children in The Netherlands suffer from constipation.
Constipation is a debilitating condition characterized by infrequent painful
defecation, involuntary loss of faeces in the underwear and abdominal pain. It
causes distress to child and family and results in severe emotional disturbance
and family discord. However, the compliance of taking medication is
approximately 50%. Therefore there is a need for alternative laxative to
succesfully treat children with constipation. Recently, a mixture of
probiotics was effective in the treatment of childhood constipation. The
hypothesis is that probiotics stimulate colonic motility and thus enhances
defecation.
To date no studies are available evaluating the effect of the probiotic strain
Bifidobacterium breve on childhood constipation.

Hypothesis: The probiotic strain Bifidobacterium breve results in a significant
increase in defecation frequency in children with constipation.

Aim: Is the Bifidobacterium breve effective in the treatment of childhood
constipation.

This is a cohort pilot study.

Prior to the study enrolment, children and their parents record defecation
frequency, consistency of stools, pain during defecation and frequency of
episodes of faecal incontinence in a validated bowel diary for one week. At
intake a general medical history and physical examination will be performed.
Children fulfilling the Rome III criteria for childhood constipation will be
offered to participate in the study.

The study protocol will last 6 weeks. All children receive one sachet of powder
per day for 4 weeks. The patients are allowed to mix the powder with all
liquids on condition that the liquid isn*t hot. The probiotics will be given in
combination with toilet training. If a child does not defecate for three days
during these 4 weeks, a stimulant laxative (bisacodyl 5-10 mg) will be
prescribed on the fourth day. During the treatment phase defecation frequency,
consistency of stools, pain during defecation and the frequency of episodes of
faecal incontinence and possible adverse effects such as abdominal pain,
bloating, flatulence, nausea, diarrhoea and bad taste will be recorded in a
validated defecation diary.

After 4 weeks the study medication is stopped and a follow-up visit is
scheduled at 6 weeks. Also during these 2 weeks defecation frequency,
consistency of stools, pain during defecation and the frequency of episodes of
faecal incontinence and possible adverse effects such as abdominal pain,
bloating, flatulence, nausea, diarrhoea and bad taste will be recorded in a
validated defecation diary.

Clinical evaluation and assessment of diaries will be carried out at enrolment
and at 2, 4 and 6 weeks.

intervention 1 sachet per day of powder with Bifidobacterium breve during 4
weeks

The scarce literature suggests that risk of infection with Lactobacilli or
Bifidobacteria is similar to risks with commensal strains. There have been no
serious adverse events reported in the treatment of children with
Bifidobacteria.