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.
ID
Bron
Verkorte titel
Aandoening
Childhood constipation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint is the stool frequency change from baseline to 3 weeks of product consumption.
Achtergrond van het onderzoek
-
Doel van het onderzoek
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.
Onderzoeksopzet
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).
Onderzoeksproduct en/of interventie
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).
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1501 |
| NTR-old | NTR1571 |
| Ander register | : NU233 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |