Please select the arm or intervention descriptions that belong 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: Intervention Type: DIETARY_SUPPLEMENT; Name: Lactobacillus reuteri (DSM 17938); Assigned to Arm(s): N/A
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: 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
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: A