Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru
Brief Summary: This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr) strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric diarrhea in Peru.


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:

* Children ages 2-5 years with no exclusion criteria

Exclusion Criteria:

* 1) No enrollment of family members in households where any of the following are present:

  1. Another study participant in the household
  2. Pregnancy or current breastfeeding by any household member
  3. Presence of an infant under age 6 months living in the household
  4. Presence of immune suppressed individuals or use of immunosuppressive agents (including but not limited to corticosteroids and methotrexate, etc.) by any household member
  5. Presence of a serious congenital anomaly or chronic medical condition that in the opinion of the investigators would contraindicate participation in any household member, including history of gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy, or abnormal bowel functionality

     2) Allergy to penicillin or cephalosporins or gentamicin 3) History of antibiotic use in the last 30 days 4) Use of probiotic products within the past 90 days, including masato (local product with fermenting bacteria) and yogurt products containing live bacterial cultures.

     5) History of diarrheal illness within the past 30 days 6) Presence of fever or a pre-existing adverse event monitored in the study 7) Positive results on serum diagnostic tests for antibodies to HIV.

     Testing for Hepatitis B core antigen, and Hepatitis C is not necessary in children as in adults, since there is universal vaccination for Hepatitis B among children in this community, and both forms of hepatitis are rare and largely asymptomatic in this age group.

     8) Presence of severe anemia, defined as serum hemoglobin \< 8 gm/dL

     9) Out of range laboratory values for tests monitored as potential adverse events, as described in Appendix 2, B. LABORATORY VALUES, and detected based on Day 0 blood test results. However, subjects will only be excluded based on serum hemoglobin if they meet exclusion criterion 8.

     10) Pre-enrollment stool sample (collected within 14 days of Day 1 of the study) is positive for L. reuteri by PCR.
C: 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
D: Inclusion Criteria:

* Children hospitalized at the Department of Paediatrics, Children's Hospital Zagreb
* Age from 1 year to 18 years
* Signed informed consent by the parents

Exclusion Criteria:

* Immunodeficiency
* Infants from neonatal period until 1 year of age
* Re-hospitalisation (readmission in a hospital within one month)
* Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to hospitalization)
* Neoplasms
* Severe chronic diseases
* Hospitalization shorter than 3 days

Answer: B