Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study of Tolerance of an Infant Formula Supplemented With Lactobacillus Fermentum CECT5716
Brief Summary: In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.


Options:
A: Inclusion Criteria:

* Child 36-48 months of age
* Child is currently attending a daycare and has attended for 6 months or less
* Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
* Signed informed consent

Exclusion Criteria:

* Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
* Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
* Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
* Child's z-score of weight for height \< -3 according to World Health Organization criteria
B: Inclusion Criteria:

* Healthy 1 month infants exclusively formula-fed

Exclusion Criteria:

* gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux)
* gastrointestinal surgery
* cow's milk protein allergy
* metabolic disorders (diabetes, lactose intolerance)
* immune deficiency
* antibiotic prescription 1-week prior to inclusion and previous use of formula containing prebiotics or probiotics
C: Inclusion Criteria:

* Subject whose parents/legal guardians had given written informed consent,
* Male or female, aged 3 to 6 years (upper bound excluded),
* Attending day-care centres or preschools 5 days a week in the Moscow area,
* Subject found medically healthy (in particular, free of respiratory and GI tract symptoms),
* Subject who appreciated dairy products and multi-fruit flavour.

Exclusion Criteria:

* Subject whose parents were not reading and writing Russian, or not understanding informed consent or study protocol.
* Subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose, milk proteins), or with any known food or respiratory allergy.
* Subject presenting a severe evolutive or chronic pathology (Ex: cancer, tuberculosis, Crohn disease, cirrhosis, multiple sclerosis, Type I diabetes...) or any past or actual health condition that could interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease, failure to thrive...).
* Subject having experienced any infectious disease during the last 7 days.
* Subject with current diarrhoea or constipation Subject who was frequently using laxatives or who had been using laxatives during the week prior his participation to the study.
* Subject who was under artificial nutrition, had gastro-intestinal surgery or any intervention requiring general anaesthesia the last 2 months prior to his participation to the study.
* Subject with special medicated diet (obesity, anorexia, metabolic pathology, nutritional complementation...) or with eating disorders (anorexia, bulimia...).
* Subject currently receiving, or who had received during the last months, systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, antiseptics, antifungal, corticoids, vaccines, anti-histaminic molecules, non-corticoid antiinflammatory substances, immunosuppressant treatment...
* Subject already enrolled in another clinical study, or currently under an exemption period from a previous study.
* Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
D: Inclusion Criteria:

* Pregnant women from families with at least one family member having an allergic disease

Exclusion Criteria:

* Women presenting severe immunological or other chronic diseases (rheumatoid arthritis, diabetes, inflammatory bowel disease, thyroid diseases, malignancies etc.)
* Women who cannot be expected to comply with treatment
* Women currently participating or having participated in other clinical trial during the last 2 months prior to the beginning of the intervention.

Answer: B