Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
Brief Summary: Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. One of the most common indications for probiotic treatment is the prevention of antibiotic-associated diarrhea (AAD). Unfortunately, many probiotic products used for AAD are not supported by rigorous independent research, and often results in non-evidence-based usage. The overarching objective is to move research forward for the most well-studied Bifidobacterium strain. The primary aim is to test the efficacy of high dose, BB-12-supplemented yogurt in preventing AAD, compared to yogurt without BB-12, in children receiving antibiotics. Other aims are to further assess the safety of yogurt supplemented with BB-12, and to carry out longitudinal community structure and gene expression analysis of fecal microbiota to evaluate the impact of high dose BB-12 in a pediatric population receiving antibiotics. The microbiota includes hundreds of species, and its disruption is hypothesized to be an important factor in the development of AAD.


Options:
A: Inclusion criteria

1. Children at the age of 1-11 years that have been ordinated to start antibiotic treatment except for penicillin.
2. Possibility to initiate the probiotic treatment within 24 hours after the first dose of the antibiotic treatment.
3. Children whose parents or legal caregivers have signed the informed consent to participate in the study.

Exclusion criteria

1. Chronic intestinal disease.
2. Current immunodeficiency or immunosuppressive treatment.
3. Chronic or acute diarrhoeal disease.
4. Use of laxatives the week before inclusion in the study.
5. Antibiotic treatment for the last four weeks before inclusion in the study.
6. Known hypersensitivity to any of the ingredients in the probiotic product or the placebo \[potato starch, silicon dioxide, capsule (hypromellose, water) ± bacterial culture\].
7. Intake of any probiotic products for the last two weeks before inclusion in the study.
8. Patient requiring hospitalisation. Lack of parents´/legal guardians´ informed consent.
B: Inclusion Criteria:

1. Child is between ages of 3-12 years
2. Caregiver has the ability to read, speak and write English or Spanish
3. Household has refrigerator for proper storage of drink
4. Household has telephone access
5. Enrollment must take place within 24 hours of starting antibiotics
6. Child was outpatient treated
7. Child was prescribed treatment with a penicillin or cephalosporin class antibiotic regimen for 7-10 days for a respiratory infection;

The following is a list (non-exhaustive) of inclusive antibiotics:

1. Amoxicillin
2. Augmentin (amoxicillin/clavulanate)
3. Ancef (cefazolin)
4. Cefadroxil
5. Cephalexin
6. Cephradine
7. Duricef (cefadroxil)
8. Keflex (cephalexin)
9. Kefzol (cefazolin)
10. Velosef (cephradine)
11. Ceclor (cefaclor)
12. Cefotan
13. Cefoxitin
14. Ceftin (cefuroxime)
15. Cefzil (cefprozil)
16. Lorabid (loracarbef)
17. Mefoxin (Cefoxitin)
18. Zinacef (cefuroxime)
19. Omnicef (cefdinir)
20. Suprax (cefixime)
21. Dicloxacillin
22. Pen-Vee K (penicillin)

Exclusion Criteria:

1. Developmental delays
2. Any chronic condition, such as diabetes or asthma, that requires medication
3. Prematurity, or born prior to 37 weeks gestation/of pregnancy
4. Congenital anomalies
5. Failure to thrive
6. Allergy to strawberry
7. Active diarrhea (diarrhea is defined in this study as three or more loose stools per day for two consecutive days)
8. Any other medicines used except anti-pyretic medicines (pro re nata concomitant medications are allowed)
9. Parental belief of lactose intolerance
10. History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic
11. History of gastrointestinal surgery or disease
12. Milk-protein allergy
13. Allergy to any component of the product or the yogurt vehicle
14. Allergy or a hypersensitivity to the antibiotic prescribed by her/his provider
15. Allergy to any of the following medications:

    1. Tetracycline
    2. Erythromycin
    3. Trimethoprim
    4. Ciprofloxacin
16. blood oxygen saturation is less than 90% (if enrollment/baseline visit is completed in person and if the participant was prescribed antibiotics during a telemedicine visit)
C: Inclusion Criteria:

* Admission to the medical, surgical, or cardiac ICU
* Age 19 years or greater (the age of majority in the state of Nebraska)
* Anticipated need for \>72 hours of endotracheal intubation
* Initial intubation during hospitalization
* Approval of the attending physician responsible for the patient's care
* Informed surrogate consent within 24 hours of intubation

Exclusion Criteria:

* Pregnancy
* Pharmacologic immunosuppression (\>10mg prednisone daily or equivalent for at least 14 days)
* Native immunosuppression: 1)known HIV disease or AIDS, 2)history of malignancy, 3)multiple organ system failure
* History of prosthetic or bioprosthetic cardiac valve placement
* History of prosthetic vascular graft placement
* Cardiac trauma
* History of rheumatic fever, endocarditis, congenital cardia abnormality, or acquired cardia abnormality
* Gastroesophageal surgery or perforation associated with current admission
* Intestinal surgery or perforation associated with current admission
* Significant oropharyngeal mucosal injury
* Placement of a tracheostomy
D: Inclusion Criteria:

* age 1-48 mo
* cause of hospitalization must be other than acute gastroenteritis or diarrhea

Exclusion Criteria:

* acute gastroenteritis within 3 days before admission
* other symptoms which suggest gastroenteritis
* usage of probiotics and/or prebiotics within 7 days before admission
* visible blood in the stool
* patient in bad condition
* lack of approval from patients parents
* breastfeeding
* no compliance

Answer: B