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Effect of the consumption of a fermented dairy product containing Bifidobacterium lactis DN-173 010 on constipation in childhood: a multicentre randomised controlled trial (NTRTC: 1571).
BMC Pediatr 2009; 9:22BPed

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.

Authors+Show Affiliations

Department of Paediatric Gastroenterology and Nutrition, Emma's Children's Hospital/Academic Medical Centre, Amsterdam, The Netherlands. m.m.tabbers@amc.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19296845

Citation

Tabbers, Merit M., et al. "Effect of the Consumption of a Fermented Dairy Product Containing Bifidobacterium Lactis DN-173 010 On Constipation in Childhood: a Multicentre Randomised Controlled Trial (NTRTC: 1571)." BMC Pediatrics, vol. 9, 2009, p. 22.
Tabbers MM, Chmielewska A, Roseboom MG, et al. Effect of the consumption of a fermented dairy product containing Bifidobacterium lactis DN-173 010 on constipation in childhood: a multicentre randomised controlled trial (NTRTC: 1571). BMC Pediatr. 2009;9:22.
Tabbers, M. M., Chmielewska, A., Roseboom, M. G., Boudet, C., Perrin, C., Szajewska, H., & Benninga, M. A. (2009). Effect of the consumption of a fermented dairy product containing Bifidobacterium lactis DN-173 010 on constipation in childhood: a multicentre randomised controlled trial (NTRTC: 1571). BMC Pediatrics, 9, p. 22. doi:10.1186/1471-2431-9-22.
Tabbers MM, et al. Effect of the Consumption of a Fermented Dairy Product Containing Bifidobacterium Lactis DN-173 010 On Constipation in Childhood: a Multicentre Randomised Controlled Trial (NTRTC: 1571). BMC Pediatr. 2009 Mar 18;9:22. PubMed PMID: 19296845.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of the consumption of a fermented dairy product containing Bifidobacterium lactis DN-173 010 on constipation in childhood: a multicentre randomised controlled trial (NTRTC: 1571). AU - Tabbers,Merit M, AU - Chmielewska,Ania, AU - Roseboom,Maaike G, AU - Boudet,Claire, AU - Perrin,Catherine, AU - Szajewska,Hania, AU - Benninga,Marc A, Y1 - 2009/03/18/ PY - 2008/12/22/received PY - 2009/03/18/accepted PY - 2009/3/20/entrez PY - 2009/3/20/pubmed PY - 2009/5/14/medline SP - 22 EP - 22 JF - BMC pediatrics JO - BMC Pediatr VL - 9 N2 - 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. SN - 1471-2431 UR - https://www.unboundmedicine.com/medline/citation/19296845/Effect_of_the_consumption_of_a_fermented_dairy_product_containing_Bifidobacterium_lactis_DN_173_010_on_constipation_in_childhood:_a_multicentre_randomised_controlled_trial__NTRTC:_1571__ L2 - https://bmcpediatr.biomedcentral.com/articles/10.1186/1471-2431-9-22 DB - PRIME DP - Unbound Medicine ER -