No registrations found.
ID
Source
Brief title
Health condition
Childhood constipation
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the stool frequency change from baseline to 3 weeks of product consumption.
Secondary outcome
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
Background summary
-
Study objective
The study objective is to show that Bifidobacterium animalis is effective in increasing defecation frequency after 3 weeks of product consumption in children with functional constipation.
Study design
The total duration of the study is approximately 5 weeks for each subject. Each patient will attend 3 clinic appointments: Inclusion visit V1 (baseline),
randomisation visit (V2) and clinical evaluation at weeks 3 (V3).
Intervention
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 Streptocccus
thermophilus (1,2.109 cfu/pot).
P.O. Box 22660
Marc A. Benninga
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663053 / +31 (0)20 5666297
m.a.benninga@amc.nl
P.O. Box 22660
Marc A. Benninga
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663053 / +31 (0)20 5666297
m.a.benninga@amc.nl
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 < 3 / week
- subjects must present 1 or more of the following criteria:
- faecal incontinence > 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
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
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 |
|---|---|
| NTR-new | NL1501 |
| NTR-old | NTR1571 |
| Other | : NU233 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |