Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation.
Brief Summary: Aim of the study. To evaluate if L. reuteri DSM 17938 supplementation since the first days of life can reduce the onset of gaseous colic in neonates and the onset of minor digestive disorders such as regurgitation and constipation.

Study Design. Double blind, randomized, controlled, multicenter study. 492 neonates of 37-42 gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28 days.

After the inclusion, at baseline will be performed :

* Paediatric visit
* antropometric valutation
* number of the daily crying minutes, number of regurgitation and number of daily evacuation

The patients will receive the probiotics/placebo every days for 28 days and the 29th will be repeated the following analyses:

* Paediatric visit
* antropometric valutation
* number of daily crying minutes
* numbers of regurgitation
* numbers of evacuations

Primary outcome :

To define if Lactobacillus reuteri supplementation can reduce the onset of gaseous colic, regurgitation and of constipation.

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


Options:
A: Arm Label: daily probiotic; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Lactobacillus reuteri DSM 17938, Dietary Supplement: Bifidobacterium longum infantis | Arm Label: weekly probiotic; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Lactobacillus reuteri DSM 17938, Dietary Supplement: Bifidobacterium longum infantis | Arm Label: bi-weekly probiotic; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Lactobacillus reuteri DSM 17938, Dietary Supplement: Bifidobacterium longum infantis | Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DIETARY_SUPPLEMENT; Name: Lactobacillus reuteri DSM 17938; Assigned to Arm(s): bi-weekly probiotic, daily probiotic, weekly probiotic | Intervention Type: DIETARY_SUPPLEMENT; Name: Bifidobacterium longum infantis; Assigned to Arm(s): bi-weekly probiotic, daily probiotic, weekly probiotic
B: Arm Label: Lactobacillus reuteri; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Lactobacillus reuteri | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Lactobacillus reuteri; Assigned to Arm(s): Lactobacillus reuteri | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo
C: Intervention Type: DRUG; Name: Mixture of probiotic bacteria and prebiotic oligosaccharide; Assigned to Arm(s): N/A
D: Arm Label: Probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Probiotics | Arm Label: Probiotics + Dietary counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary counselling and probiotics | Arm Label: Dietary counseling + placebo; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary counselling and placebo | Arm Label: Prebiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Prebiotics | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo capsules | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Dietary counselling and placebo; Assigned to Arm(s): Dietary counseling + placebo | Intervention Type: BEHAVIORAL; Name: Dietary counselling and probiotics; Assigned to Arm(s): Probiotics + Dietary counseling | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo capsules; Assigned to Arm(s): Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotics; Assigned to Arm(s): Probiotics | Intervention Type: DIETARY_SUPPLEMENT; Name: Prebiotics; Assigned to Arm(s): Prebiotics

Answer: B