Please select the eligibility criteria that correspond to the clinical trial below.
Title: Open-labelled, Controlled, Parallel Group Study to Assess the Efficacy and Safety of MUTAFLOR in 3 Weeks Treatment for Immunity Improvement in Preterm Infants With 1 Year Follow-up Period
Brief Summary: EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers including those on tube feeding tube, diarrhea in children, prophylactics of pathological colonization in newborns including premature newborns, and improvement of immunity in newborns (mature and premature).

The aim of this trial was to observe efficacy and safety of Mutaflor® SUSPENSION use for immunity improvement in preterm newborn infants


Options:
A: Inclusion Criteria:

* age 12-24 hours of life;
* 1st degree of prematurity (functionally mature infant, gestational age 35-36 weeks);
* exclusive breast feeding during study;
* both parents must sign and date an informed consent for infant's participation in the study.

Exclusion Criteria:

* perinatal asphyxia ( Apgar score less than 8);
* significant concomitant disease (congenital birth defects, perinatal encephalopathy, TORCH - infections and other infectious disease of newborn, respiratory distress syndrome ets);
* clinically significant changes in blood analyze results (if needed);
* use of other probiotics or prebiotics during the first 28 days of study participation.
B: Inclusion Criteria:

* Able to give informed consent
* Over 60 years old without any health problems
* The levels of white blood cells within range 4x10\^3/μL\~10x10\^3/μL

Exclusion Criteria:

* Individuals who get a cold
* Diabetes
* Hypersensitivity or disease history for milk protein
* Epilepsy, neurological, or psychological disease
* Alcoholism or drug addiction
* Liver disease or severe kidney failure disease
* Inflammation-related disease
* Consumption of other test products or drugs within 1 month prior to screening
* Regular consumption of immune-related functional foods including yogurt or milk within 1 month prior to screening
* History of inflammation-related disease or taking medication to treat inflammation-related disease within 1 month prior to screening
* History of cancer within 5 years
* Any inappropriate condition
C: Inclusion Criteria:

* mother or father fo child with doctor diagnoses allergic disease

Exclusion Criteria:

* prematurity, major malformations
D: Inclusion Criteria:

AT ENROLLMENT:

* Subject must be 18-60 years of age.
* Subject must read and sign a copy of the approved Consent Form
* Female subjects must be using an effective birth control method.

INCLUSION CRITERIA AT DAY -28

* Subject must read and sign a copy of the approved Consent Form

AT CHALLENGE:

* Female subjects must be using an effective birth control method.
* Subject must have a serum neutralizing antibody titer of less than or equal to 1:4 to rhinovirus type 39

Exclusion Criteria:

AT ENROLLMENT:

* Current cancer diagnosis or immunosuppressive therapy in the last 6 months
* Any clinically significant abnormalities of the upper respiratory tract
* Any clinically significant acute or chronic respiratory illness
* Any clinically significant bleeding tendency by history
* Hypertension that requires treatment with antihypertensive medications
* History of angina or other clinically significant cardiac disease
* Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study
* History of regular use (more than 3 days in 7) of tobacco products within the preceding two weeks
* History of drug or alcohol abuse in the 6 months preceding the study

EXCLUSION CRITERIA AT DAY -28

* Antibiotic use within 3 months prior to study start
* Female subjects with a positive urine pregnancy screen.
* History of use of probiotics in the preceding 2 weeks.

EXCLUSION CRITERIA AT CHALLENGE:

* Any upper respiratory infection or allergic rhinitis in the two weeks prior to the start of the study
* Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study
* Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold preparation in the two weeks prior to the study

Answer: A