Effect of Probiotics on Infections in Infants. Clinical Trial
Official title:
Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months: a Double-blind, Randomized, Placebo-controlled Study.
| Verified date | October 2013 |
| Source | Fonterra Research Centre |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
The purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week probiotic supplementation on the incidence and duration of infectious episodes in infants aged 6 to 12 months.
| Status | Completed |
| Enrollment | 192 |
| Est. completion date | April 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Months to 12 Months |
| Eligibility |
Inclusion Criteria: - Age 6 to 12 months. - Known vaccination history. - Ability of the participant's parent or legal guardian to comprehend the full nature and purpose of the study including possible risks and side effects. - Parental or legal guardian's consent to the study and willing to comply with study procedures. Exclusion Criteria: - Symptoms of any infection at screening. - History of =5 infections in the previous 2 months. - Lactose intolerance or unable to drink milk. - Leukopenia or leukocytosis. - Immunodeficient or use of immunosuppressive drugs. - Use of antibiotic and anti-inflammatory medications within the last 2 weeks. - Use of products containing prebiotics or probiotics within the last 2 weeks. - Use of low-lactose or lactose-free infant or follow-on formula within the last 2 weeks. - Hepatitis B or C. - Medications or supplements that may affect subject safety or confound study outcomes in the opinion of the investigator. - Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator. - Participation in another study with any investigational product within 3 months of screening. - Any other condition that, in the investigator's opinion, may preclude the subject's ability to safely complete the trial. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| China | Shanghai Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Fonterra Research Centre | Sprim Advanced Life Sciences, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The proportion of subjects with one or more of confirmed bacterial or viral infections at any time during the study | The primary endpoint of this clinical trial is the proportion of subjects with one or more of the following confirmed bacterial or viral infections at any time during the study: fever > 37.5ºC (axillary), upper respiratory tract infection, lower respiratory tract infection, pneumonia, strep throat, diarrhea, and otitis media. | 12 weeks | No |
| Secondary | Cumulative days with infectious symptoms | Cumulative number of days with infectious symptoms will be defined as the total number of days during the study on which a subject has symptoms of a confirmed infection. Confirmed infections that count toward the primary endpoint include: fever >37.5°C (axillary), upper respiratory tract infection, lower respiratory tract infection, pneumonia, strep throat, diarrhea, and otitis media. | 12 weeks | No |
| Secondary | Cumulative number of infectious episodes | Cumulative number of infectious episodes will be defined as the total number of infectious episodes (defined as presence of one of more symptoms of a confirmed infection) experienced during the study. An infectious episode will be defined as a period when symptoms of a confirmed infection last for more than 24 hours and are followed by at least 3 days of no symptoms. | 12 weeks | No |
| Secondary | Stool frequency | Parents will record the number of infant defecations each day in a diary during the 12-week supplementation period. | 12 weeks | No |
| Secondary | Stool Consistency | Parents will rate the consistency of each infant bowel movement by using the Bristol Stool Scale Form. Parents will record stool consistency each day during the 12-week supplementation period. | 12 weeks | No |
| Secondary | Infant Characteristics Questionnaire | The Infant Characteristic Questionnaire for infants approximately 6 months old (ICQ-6) measures parental perception of infant temperament, focusing on difficult temperament 8. The questionnaire is comprised of 24 items describing infant behavior. The parent or primary caregiver ranks each item on a 7-point scale, indicating the level of perceived difficulty in dealing with the described behavior. Four subscales have been identified through principal components analyses: Fussy/Difficult, Unadaptable, Dull, and Unpredictable. | 12 weeks | No |
| Secondary | Treatments for infectious episodes | Treatments that are taken to alleviate infectious symptoms will be documented in a daily diary. | 12 weeks | No |
| Secondary | Adverse events | Adverse events will be recorded in the daily diary and at study visits during the 12-week supplementation period. | 12 weeks | No |