Childhood constipation
Conditions
Interventions
Fermented dairy product Activia® (125-g pot) containing
Bifidobacterium animalis DN-173 010, 1.2 1010 colony forming units (cfu) per pot
and a yoghurt symbiosis Lactobacillus bulgaricus and Streptoccc
Sponsors
Danone Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children (boys and girls) aged from 3 to 16 years 2. Children with a diagnosis of functional constipation according to Rome III criteria (Rasquin et al.): - subjects must present defecation frequency 1 / week - large amount of stools which clog the toilet - painful defecation - withholding behaviour - abdominal or rectal faecal impaction upon physical examination 3. Children with a diagnosis of functional constipation according to Rome III criteria fulfilled for the last 2 months 4. Children with usual consumption of dairy products and ready to consume 2 pots per day 5. Children having given written consent to take part in the study (in The Netherlands: children and parents for children above 12 years and only parents for children under 12 years; in Poland: children and parents for children above 16 years and only parents for children under 16 years)
Exclusion criteria
Exclusion criteria: 1. Children with a diagnosis of IBS according to Rome III criteria 2. Children treated for constipation less than 2 weeks before intake in the study 3. Children with mental retardation or metabolic disease (hypothyroidism) 4. Children with Hirschsprung¡¯s disease or spinal anomalies or anorectal pathology 5. Children who underwent gastro-intestinal surgery 6. Children with functional non-retentive faecal incontinence 7. Children with lactose intolerance or known allergy to product component (milk protein for example) 8. Children who started a medication with antibiotics in the prior month 9. Children receiving medication influencing gastrointestinal motility (for examples Cisapride, Motilium, Erythromycin, laxatives, Loperamide)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the stool frequency change from baseline to 3 weeks of product consumption. | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool frequency over 3 weeks and at week 1 and 2 of product consumption. - Stool consistency over 3 weeks and per week of product consumption. - Frequency of episodes of faecal incontinence over 3 weeks and per week of product consumption. - Pain during defecation over 3 weeks and per week of product consumption. - Digestive symptoms: abdominal pain and flatulence over 3 weeks and per week of product consumption. - Adverse effects: nausea, diarrhoea and bad taste over 3 weeks and per week of product consumption. - Intake of Bisacodyl over 3 weeks and per week of product consumption. - Rate of success defined as 3 or more bowel movements per week and less than 1 faecal incontinence episode in 2 weeks over the last 2 weeks of product consumption - Rate of responders defined as a subject who reports a stool frequency ¡Ý 3 on the last week of product consumption | — |
Contacts
Public ContactMarc A. Benninga
Kinderarts MDL, AMC, H7-248 P.O. Box 22660
Outcome results
None listed