constipation
Conditions
Interventions
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 ferme
Sponsors
Danone Vitapole
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Children (3 - 16 years of age) with untreated constipation fulfilling the Rome III-criteria: ;1) Defecation frequency 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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure: Effect on stool frequency at 3 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed