Original Investigation | Journal Club

Prophylactic Use of a Probiotic in the Prevention of Colic, Regurgitation, and Functional Constipation:  A Randomized Clinical Trial

Flavia Indrio, MD1; Antonio Di Mauro, MD1; Giuseppe Riezzo, MD2; Elisa Civardi, MD3; Cristina Intini, MD4; Luigi Corvaglia, MD5; Elisa Ballardini, MD6; Massimo Bisceglia, MD7; Mauro Cinquetti, MD8; Emanuela Brazzoduro, MD9; Antonio Del Vecchio, MD10; Silvio Tafuri, MD, PhD11; Ruggiero Francavilla, MD, PhD1
[+] Author Affiliations
1Department of Pediatrics, Aldo Moro University of Bari, Bari, Italy
2Laboratory of Experimental Physiopathology, National Institute for Digestive Diseases, IRCCS “Saverio de Bellis,” Castellana Grotte, Italy
3Division of Neonatology, Department of Pediatrics, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
4Division of Neonatology, Department of Pediatrics, Ospedale S.S. Annunziata, Taranto, Italy
5Division of Neonatology, Department of Pediatrics, S. Orsola-Malpighi University Hospital, Bologna, Italy
6Division of Neonatology, Department of Pediatrics, University of Ferrara, Ferrara, Italy
7Division of Neonatology, Department of Pediatrics, San Giovanni di Dio Hospital, Crotone, Italy
8Department of Pediatrics, Ospedale Fracastoro, San Bonifacio, Italy
9Division of Neonatology, Department of Pediatrics, Ospedale Sesto San Giovanni, Sesto San Giovanni, Italy
10Division of Neonatology, Di Venere Hospital, Bari, Italy
11Department of Biomedical Sciences and Human Oncology, Section of Hygiene, Aldo Moro University of Bari, Bari, Italy
JAMA Pediatr. 2014;168(3):228-233. doi:10.1001/jamapediatrics.2013.4367.
Text Size: A A A
Published online

Importance  Infantile colic, gastroesophageal reflux, and constipation are the most common functional gastrointestinal disorders that lead to referral to a pediatrician during the first 6 months of life and are often responsible for hospitalization, feeding changes, use of drugs, parental anxiety, and loss of parental working days with relevant social consequences.

Objective  To investigate whether oral supplementation with Lactobacillus reuteri DSM 17938 during the first 3 months of life can reduce the onset of colic, gastroesophageal reflux, and constipation in term newborns and thereby reduce the socioeconomic impact of these conditions.

Design  A prospective, multicenter, double-masked, placebo-controlled randomized clinical trial was performed on term newborns (age <1 week) born at 9 different neonatal units in Italy between September 1, 2010, and October 30, 2012.

Setting  Parents were asked to record in a structured diary the number of episodes of regurgitation, duration of inconsolable crying (minutes per day), number of evacuations per day, number of visits to pediatricians, feeding changes, hospitalizations, visits to a pediatric emergency department for a perceived health emergency, pharmacologic interventions, and loss of parental working days.

Participants  In total, 589 infants were randomly allocated to receive L reuteri DSM 17938 or placebo daily for 90 days.

Interventions  Prophylactic use of probiotic.

Main Outcomes and Measures  Reduction of daily crying time, regurgitation, and constipation during the first 3 months of life. Cost-benefit analysis of the probiotic supplementation.

Results  At 3 months of age, the mean duration of crying time (38 vs 71 minutes; P < .01), the mean number of regurgitations per day (2.9 vs 4.6; P < .01), and the mean number of evacuations per day (4.2 vs 3.6; P < .01) for the L reuteri DSM 17938 and placebo groups, respectively, were significantly different. The use of L reuteri DSM 17938 resulted in an estimated mean savings per patient of €88 (US $118.71) for the family and an additional €104 (US $140.30) for the community.

Conclusions and Relevance  Prophylactic use of L reuteri DSM 17938 during the first 3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition.

Trial Registration  clinicaltrials.gov Identifier: NCT01235884

Figures in this Article

Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours


Place holder to copy figure label and caption
Flowchart of the Participants’ Progression Through the Study

Data represent children included in the study and the total number evaluated.

Graphic Jump Location





You need to register in order to view this quiz.
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).
Submit a Comment
Was infant feeding a confounder?
Posted on January 23, 2014
Maureen Minchin
Conflict of Interest: None Declared
Can you please supply all relevant details of infant feeding data collected? How many -if any- children were exclusively breastfed from birth to study end?What duration of exclusive breastfeeding (If any) in others? How many were solely formula fed from birth to study end? Was a comparison of solely breastfed and solely formula-fed for the three months study period attempted or possible? What type of infant formula was used? how many parents changed formulas during the study, and was this significant? What detailed analysis of infant feeding as a potential confounder was undertaken, (or could be now undertaken from data collected) given the significant effects of feeds on infant microbiome, and the 700+spp in breastmilk? Were any comparative faecal flora studies done?
Submit a Comment


Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

Related Content

Customize your page view by dragging & repositioning the boxes below.

See Also...
Articles Related By Topic
Related Topics
PubMed Articles