Please select the eligibility criteria that correspond to the clinical trial below.
Title: Influence of a Delivery System on the Efficacy of a Probiotic Intervention
Brief Summary: In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or after fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time); 2) the ecology of the bacterial community in the GIT; and 3) immune status of healthy human volunteers. In addition to providing information about the relative efficacy of the delivery vehicles on probiotic function it will provide novel information about the influence of the yogurt smoothie alone (control) on all the parameters measured.


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:

* 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
C: Inclusion Criteria:

* mother or father fo child with doctor diagnoses allergic disease

Exclusion Criteria:

* prematurity, major malformations
D: Inclusion Criteria:

* Generally healthy
* Men and women
* 18-40 years of age
* Body mass index between 20 and 35 kg/m\^2
* Persons with irregular bowel function as determined using the Rome III criteria (1) which is used to classify functional gastrointestinal disorders.
* Increased gastrointestinal transit time \> 60 hours.

Exclusion Criteria:

* Smoking and/or use of other tobacco products
* Blood pressure greater than 140/90 mm Hg
* A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease and thyroid disease (unless controlled by medication and blood results within the previous 6 months are provided).
* Lactation, pregnancy or desire to become pregnant during the study
* Use of cholesterol-lowering medication
* Refusal to discontinue intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, stanol/sterol supplemented foods
* Refusal to discontinue probiotics,nutritional supplements, herbs or vitamins
* Vegetarianism/Veganism
* Lactose intolerance
* Clinical diagnosis of Inflammatory Bowel Disease (IBD), e.g. Crohn's Disease or ulcerative colitis
* Excessive alcohol consumption (\> 14 standard drinks per week)
* Chronic use of anti-inflammatory medications (unless able to discontinue)
* Individuals taking stool softeners or enemas on a regular basis.
* Allergy to polyvinyl chloride (PVC) or any other type of plastic
* Individuals with a bowel transit time of \< 60 hours at time of screening
* Individuals with swallowing disorders or dysphagia to food or pills
* Suspected strictures, fistulas, or physiological GI Obstruction
* GI surgery within the past three months
* Refusal to agree to give blood or plasma for the length of the study.

Note: If a participant experiences a delay in passing the capsule (beyond five days) they will be treated accordingly and excluded from future participation in the study.

Answer: D