Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Lactobacillus Rhamnosus (LGG®) on the Defence Against Pathogens in the Upper Respiratory Tract in Healthy Children - a Single-center, Randomized, Double-blind, Placebo-controlled Study With 16 Weeks Intervention.
Brief Summary: This study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study in healthy children aged 2-6 years. The study will investigate the effect of daily intake of a probiotic on Upper Respiratory Tract Infections (URTI) during a 16-week intervention.


Options:
A: 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.
B: Inclusion Criteria:

* males and females
* age 18-70 years
* increased risk for common cold (at least 4 episodes within 12 months)
* commitment to adhere to former diet and physical activity
* commitment not to use any products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) during the study (except for rescue medication, see 7.5)
* women of child-bearing potential have to agree to use appropriate birth control methods Written consent of the subject to participate is a prerequisite for study participation.

Exclusion Criteria:

* acute / chronic upper / lower airways disease
* chronic cough of any origin
* any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis)
* history of nasal reconstructive surgery
* presence of nasal ulcers or nasal polyps
* severe nasal septum deviation or other condition that could cause nasal obstruction
* congenital or acquired immunodeficiency disease (e.g. HIV infection)
* Bechterew's disease
* body temperature above 37.5°C
* suspected swine flu or influenza
* vaccination with a vaccine containing an adjuvant within 3 months prior to study start and during the study
* vaccination with a vaccine not containing an adjuvant within 6 weeks prior to study start and during the study
* stomach/gastrointestinal diseases
* serious organ or systemic diseases
* sleep disorder
* psychiatric disorders
* known sensitivity to the ingredients of the investigational product
* regular intake of products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) within the last 4 weeks prior to study start
* habitual usage of nasal drops/spray
* pregnancy or nursing
* alcohol / drug abuse
* simultaneous participation in another clinical trial or participation in a clinical trial within the last 30 days
* insufficient compliance
C: Inclusion Criteria:

* Apparently healthy children aged 1-6 years, with emphasize on aged 2-5 years, living permanently in low socio-economic urban areas of East Jakarta for at least 6 months
* Parents are willing to sign the informed consent and give the supplements to the children for the period of 6 months
* Capable and willing to drink liquid milk with a straw (acceptance to be tested at screening by providing a sample drink and placebo straw to be consumed under supervision for 2 days)

Exclusion Criteria:

* Calcium intake exceeding 75% of the RDA for calcium (\<375 mg/d) based on a Food Frequency Questionnaire
* Currently breastfed children
* Siblings of already included children that are living in the same household, except if it is a twin sibling
* Severely malnourished with or without oedema (Weight for height-WHZ Z-score of \<-3.00 SD)
* Symptoms of chronic/congenital diseases and disabilities, suspected Tuberculosis by clinical examination, and /or history of allergic disease.
* Taking (any) antibiotics during 2 weeks prior to start of the study (children will be included after 3 weeks of last antibiotic intake
* Participation in another clinical trial at the same time or 2 months prior to the start of this study
* Both mothers and other caregivers present in the family are illiterate
D: Inclusion Criteria:

1. Children aged 2-6 years, both inclusive, at the time of informed consent
2. No URTI at the time of inclusion as assessed by a GP
3. Attending day-care with at least 10 children or primary school with at least 10 children in the class for at least 20 hours a week
4. Generally healthy as determined by a GP
5. Guardian consents to participate in the study and to comply with all its procedures

Exclusion Criteria:

1. Any known concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis, congenital cardiac defects.
2. Suspected or challenge-proved food allergy
3. Use of any prescribed immune suppressive medications at enrolment
4. Use of oral or IV antibiotics in the 1 month before randomisation
5. Not willing to exclude pre/pro/synbiotics during the study
6. Intake of Echinacea, high dose vitamins or Zinc four weeks before and during the study period.
7. Language limitations regarding interviews or questionnaires
8. Participation in other clinical studies in the last 2 months
9. Planning extensive travel (for \>1 month) during the duration of the study

Answer: D