Abstract | BACKGROUND:
Constipation is a frustrating symptom affecting 3% of children worldwide. Randomised controlled trials show that both polyethylene glycol and lactulose are effective in increasing defecation frequency in children with constipation. However, in 30-50%, these children reported abdominal pain, bloating, flatulence, diarrhoea, nausea and bad taste of the medication. Two recent studies have shown that the fermented dairy product containing Bifidobacterium lactis strain DN-173 010 is effective in increasing stool frequency in constipation-predominant irritable bowel syndrome patients with a defecation frequency < 3/week and in constipated women with a defecation frequency < 3/week. Goal of this study is to determine whether this fermented dairy product is effective in the treatment of constipated children with a defecation frequency < 3/week. METHODS/DESIGN: It is a two nation (The Netherlands and Poland) double-blind, placebo-controlled randomised multicentre trial in which 160 constipated children (age 3-16 years) with a defecation frequency <3/week will be randomly allocated to consume a fermented dairy product containing Bifidobacterium lactis DN-173 010 or a control product, twice a day, for 3 weeks. During the study all children are instructed to try to defecate on the toilet for 5-10 minutes after each meal (3 times a day) and daily complete a standardized bowel diary. Primary endpoint is stool frequency. Secondary endpoints are stool consistency, faecal incontinence frequency, pain during defecation, digestive symptoms ( abdominal pain, flatulence), adverse effects ( nausea, diarrhoea, bad taste) and intake of rescue medication ( Bisacodyl). Rate of success and rate of responders are also evaluated, with success defined as > or = 3 bowel movements per week and < or =1 faecal incontinence episode over the last 2 weeks of product consumption and responder defined as a subject reporting a stool frequency > or = 3 on the last week of product consumption. To demonstrate that the success percentage in the intervention group will be 35% and the success percentage in the control group (acidified milk without ferments, toilet training, bowel diary) will be 15%, with alpha 0.05 and power 80%, a total sample size of 160 patients was calculated. CONCLUSION: This study is aimed to show that the fermented dairy product containing Bifidobacterium lactis strain DN-173 010 is effective in increasing stool frequency after 3 weeks of product consumption in children with functional constipation and a defecation frequency < 3/week.
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Authors | Merit M Tabbers, Ania Chmielewska, Maaike G Roseboom, Claire Boudet, Catherine Perrin, Hania Szajewska, Marc A Benninga |
Journal | BMC pediatrics
(BMC Pediatr)
Vol. 9
Pg. 22
(Mar 18 2009)
ISSN: 1471-2431 [Electronic] England |
PMID | 19296845
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Topics |
- Adolescent
- Bifidobacterium
- Child
- Child, Preschool
- Constipation
(ethnology, physiopathology, therapy)
- Dairy Products
- Defecation
- Double-Blind Method
- Female
- Humans
- Male
- Netherlands
- Poland
- Treatment Outcome
- Yogurt
(microbiology)
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