The Effect of Probiotics on Infections in Toddlers

Zealand University Hospital

Status and phase: Completed; Phase 3

Conditions: Respiratory Diseases; Diarrhoea

Treatments: Dietary Supplement: probiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00823056

Version 2

Details and patient eligibility

About

Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children.

The investigators hypothesis is: if young children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.

Full description

Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children.

Our hypothesis is: if young healthy children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics( BB12 and TH4) in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.

Enrollment: 454 patients

Sex: All

Ages: 6 to 7 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Children born in University Hospital Holbaek,Hospital North,Region Zealand, Denmark in the period of Jan. 2009 to Oct. 2010
• Gestational age > 36. weeks

Exclusion criteria

• Chronical heart or lung conditions
• Short Bowel Syndrome
• CVC (Central Venous Catheter)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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454 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Dietary Supplement: probiotics

Dietary Supplement: probiotics

2

Active Comparator group

Treatment:

Dietary Supplement: probiotics

Dietary Supplement: probiotics