Please select the eligibility criteria that correspond to the clinical trial below.
Title: Lactobacillus Reuteri (DSM 17938) for the Treatment of Infantile Colic: a Randomized Double-blind Placebo Controlled Trial
Brief Summary: Infantile colic is characterized by excessive crying (defined as crying that last at least 3 hours a day, for 3 days a week, for at least 3 weeks) in an otherwise healthy infant. The crying typically starts in the first few weeks of life and ends by 4-5 months of age. The condition is usually self-limited, with no long-term adverse effects; however, it may be very distressing to parents, hence, any safe and effective treatment would be desirable. Recently, it has been suggested that probiotics may offer some benefit.This is based on the results of one open randomized controlled trial. In this trial, 83 breast-fed infants with colic defined as \>3 hours of crying on \>3 days/week were randomly allocated to receive Lactobacillus reuteri DSM 17938 (108 colony-forming units, once daily 30 minutes after feeding) or simethicone (60 mg/day as 15 drops twice a day after feeding) for 28 days. Mothers followed a cow's milk free diet. By day 28 after randomization, mothers of infants in the probiotic group were significantly more likely than mothers of infants in the simethicone group to report a reduction from baseline in average crying time to less than 3 hours per day (95% vs. 7%). In addition, median crying times were significantly shorter in the probiotic group than in the simethicone group. No adverse effects of L. reuteri were reported.

Although the mechanism of action of L. reuteri for treating infantile colic has not been elucidated yet, the findings are very promising. However, there are some methodological limitations to the study, including no allocation concealment, no blinding, and no intention-to-treat analysis; these may result in selection, performance, and/or attrition biases and, eventually, invalidate the results. Another limitation of the study is the lack of a true placebo group. Given these consideration a new study is proposed that is aiming to overcome these limitations.


Options:
A: Inclusion Criteria:

* Full-term infants age \<5 months
* Infantile colic (\>3 hours of crying on \>3 days in the week) within 7 days prior to enrollment
* Exclusive or predominant (\>50%) breastfeeding
* Informed consent

Exclusion Criteria:

* Acute or chronic illness
* Gastrointestinal disorders
* Use of any antibiotics and/or probiotic pharmaceutical products within 7 days prior to the study.
B: Inclusion Criteria:

* neonates of 37-42 week gestational age and appropriate birth weight
* Recruitment age: until 7 days of life
* Informed consent signed

Exclusion Criteria:

* Presence of other gastrointestinal diseases.
* Use of FANS, aspirin or other drugs
* Use of antibiotics and/or PPIs e/o anti-H2
* Participation to other clinical trials
C: Inclusion Criteria:

* Healthy infants.
* Infants 1 -3 months of age at the beginning of the study.
* Parents/guardians of each subject are able to understand study procedures and agree to participate in the study by giving consent.
* Parents and child are planning to remain in Dhaka for the next four months.

Exclusion Criteria:

* Infants with known birth defects.
* Infants who have been hospitalized.
* Infants who have an acute infection or illness at the time of enrolment.
* Infants who are currently taking antibiotics
* Infants \<1 month of age or \>3 months of age.
* Infants three standard deviations below mean on anthropometric measures (will be referred for medical care).
* Infants who are already receiving a probiotic product or treatment.
* A diagnosis or suspicion of immunodeficiency disorder.
* A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
* Family residence outside of Dhaka or families expecting to move outside of Dhaka in the next 4 months.
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: A