Effect of the consumption of a fermented dairy product on constipation in childhood: a multi-centre randomized controlled trial.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR1571
• Date of registration: 02/12/2008
• Primary sponsor: Academic Medical Center (AMC), Emma Children's Hospital
• Public title: Effect of the consumption of a fermented dairy product on constipation in childhood: a multi-centre randomized controlled trial.
• Scientific title: Effect of the consumption of a fermented dairy product on constipation in childhood: a multi-centre randomized controlled trial. - Nu233
• Date of first enrolment: 1/1/2008
• Target sample size: 160
• Recruitment status: other
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1571
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: Marc A. Benninga

• Name: Marc A. Benninga

Key inclusion & exclusion criteria

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)


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Constipation, Children

Intervention(s)

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).

Primary Outcome(s)

The primary endpoint is the stool frequency change from baseline to 3 weeks of product consumption.

Secondary Outcome(s)

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

Secondary ID(s)

NU233

Source(s) of Monetary Support

Danone Research B.V.