Acute Upper Respiratory Tract Infections (Common Cold) Clinical Trial
Official title:
A Randomized, Double Blind, Placebo-controlled Study to Investigate the Effect of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy Children
| Verified date | October 2018 |
| Source | Probi AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of the present study is to test the efficacy of the combination of two probiotic bacteria in reducing the severity of upper respiratory tract infections (common cold) in healthy children attending day care or school. The probiotic bacteria used are Lactobacillus plantarum strain DSM 15312 and Lactobacillus paracasei DSM 13434 at a total dose of 1 x 10^9 CFU/tablet and day and will be consumed for a period of 12 weeks.
| Status | Completed |
| Enrollment | 550 |
| Est. completion date | September 2018 |
| Est. primary completion date | June 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 3 Years to 7 Years |
| Eligibility |
Inclusion Criteria: 1. Parents / legal guardians signed written informed consent to participate in the study. 2. Healthy children (male and female) aged 3 to 7 years old (inclusive) at enrollment. 3. Children attending day care center or school. 4. No consumption of commercial products containing probiotics during the whole study period. 5. Children not being intensive consumers of regular yoghurts (no more than one 125 g serving per day). 6. Ability of the parents / legal guardians (in the Investigator's opinion) to comprehend the full nature and purpose of the study. 7. Parents' / legal guardians' consent to the study and willing to comply with all its procedures. Exclusion Criteria: Children presenting one or more of the following criteria will not be eligible to enter the study. 1. Flu vaccine administration within the last 3 months prior to enrollment. 2. Use of antibiotics within the last 30 days prior to enrollment. 3. Acute infection or fever at enrollment. 4. Any congenital or chronic disease that in the opinion of the investigator would adversely affect the results of the study. 5. Any kind of immunodeficiency or allergy (including known food allergy). 6. Subjects with known hypersensitivity or allergy to any component of the study products. 7. Significant illness within the 2 weeks prior to the enrollment or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study. 8. Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | AO L. Sacco | Milano |
| Lead Sponsor | Collaborator |
|---|---|
| Probi AB |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Severity of acute upper respiratory tract infections (common cold), by means of the validated Canadian Acute Respiratory Illness and Flu Scale (CARIFS) questionnaire (total sum score), during 12 weeks of daily intake of either Probi Defendum® or placebo. | 12 weeks | ||
| Secondary | Number of common cold episodes | 12 weeks | ||
| Secondary | Duration of common cold episodes | 12 weeks | ||
| Secondary | Incidence of common cold episodes | 12 weeks |