Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00823056
Other study ID # Version 2
Secondary ID
Status Completed
Phase Phase 3
First received January 14, 2009
Last updated April 22, 2012
Start date January 2009
Est. completion date December 2011

Study information

Verified date April 2012
Source Roskilde County Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 454
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 7 Months
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Intervention

Dietary Supplement:
probiotics
placebo
probiotics
0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months

Locations

Country Name City State
Denmark Paediatr. Depart., University Hospital Holbaek, University of Copenhagen Holbaek Region Zealand

Sponsors (5)

Lead Sponsor Collaborator
Roskilde County Hospital Chr Hansen A/S, Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK, Ferrosan A/S, Holbaek Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary fewer infections 9 months No
Secondary growth 9 months No
See also
  Status Clinical Trial Phase
Completed NCT01214785 - Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India N/A
Recruiting NCT05073003 - A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants Phase 1/Phase 2
Completed NCT01969214 - Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea N/A
Completed NCT01202383 - Double-blinded Trial of Household-based Chlorination in India Phase 3
Completed NCT01087892 - Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection N/A
Completed NCT00979056 - Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin Phase 3
Completed NCT02072629 - HCU: Can VHVs Trained in ICCM Improve Care for Children N/A
Completed NCT00408356 - Immunological and Clinical Responses to Zinc in Children With Diarrhoea Phase 3
Completed NCT01517230 - Can Mass Media Campaigns Reduce Child Mortality N/A
Completed NCT02858609 - Improving the Diagnosis of Diarrhoea in Emergency Rooms N/A
Completed NCT01306383 - Solar Disinfection (SODIS) of Drinking Water for Use in Developing Countries or in Emergency Situations N/A
Completed NCT00352716 - Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children Phase 3
Active, not recruiting NCT02606526 - Early Versus Late BCG Vaccination in HIV-1 Exposed Infants in Uganda in Uganda Phase 3
Completed NCT00352989 - Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children Phase 3
Completed NCT00324285 - Oral Rehydration SolutionContaining Amylase Resistant Starch in Severely Malnourished Children. Phase 3
Recruiting NCT02144168 - The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients N/A
Completed NCT02797353 - Strengthening Maternal Neonatal and Child Health Services in a Rural District of Pakistan N/A
Withdrawn NCT01491659 - A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate Phase 4
Completed NCT01557673 - Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow Phase 1/Phase 2
Completed NCT01154803 - Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection N/A