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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).

Tabbers MM, Chmielewska A, Roseboom MG, Boudet C, Perrin C, Szajewska H, Benninga MA - BMC Pediatr (2009)

Bottom Line: 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).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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Paediatric Gastroenterology and Nutrition, Emma's Children's Hospital/Academic Medical Centre, Amsterdam, The Netherlands. m.m.tabbers@amc.nl

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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Related in: MedlinePlus

Study planning in days (D-11 to D+21).
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Figure 1: Study planning in days (D-11 to D+21).

Mentions: See figure 1 for the study planning. 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). When a child is eligible for inclusion, a list of non-authorized products will be discussed with the child and parents at visit 1. The first 8 days will be used to obtain baseline values for the outcome parameters. After 3 days of enemas, the 3 subsequent weeks (day 0 to day 20) will constitute the treatment phase. The subjects will receive and consume 2 products (test or control product) per day. Between days 7 and 10, the subjects will receive new products, to be consumed during the second part of the treatment period, to ensure consumption before end of shelf-life of the products. They will cease consumption of the study product at the end of week 3 (day 20) and will then have their last visit on day 21. During the treatment phase, patients can take Bisacodyl 5 mg if they have no defecation for 3 consecutive days.


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).

Tabbers MM, Chmielewska A, Roseboom MG, Boudet C, Perrin C, Szajewska H, Benninga MA - BMC Pediatr (2009)

Study planning in days (D-11 to D+21).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2662858&req=5

Figure 1: Study planning in days (D-11 to D+21).
Mentions: See figure 1 for the study planning. 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). When a child is eligible for inclusion, a list of non-authorized products will be discussed with the child and parents at visit 1. The first 8 days will be used to obtain baseline values for the outcome parameters. After 3 days of enemas, the 3 subsequent weeks (day 0 to day 20) will constitute the treatment phase. The subjects will receive and consume 2 products (test or control product) per day. Between days 7 and 10, the subjects will receive new products, to be consumed during the second part of the treatment period, to ensure consumption before end of shelf-life of the products. They will cease consumption of the study product at the end of week 3 (day 20) and will then have their last visit on day 21. During the treatment phase, patients can take Bisacodyl 5 mg if they have no defecation for 3 consecutive days.

Bottom Line: 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).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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Paediatric Gastroenterology and Nutrition, Emma's Children's Hospital/Academic Medical Centre, Amsterdam, The Netherlands. m.m.tabbers@amc.nl

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.

Show MeSH
Related in: MedlinePlus