- Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject, such as, but not limited to , concomitant chronic systemic diseases, congenital cardiac defects, active tuberculosis, autoimmune diseases, immunodeficiency, chronic inflammatory bowel diseases, celiac disease, cystic fibrosis, metabolic diseases, lactose intolerance, malignancy, chronic pulmonary diseases, malformations of the gastrointestinal tract.