Effect of Probiotics on Infantile Colic in Breast-Fed Infants: A Randomized Single-Blind Clinical Trial


  • Hamed Roohanizadeh Departments of Pediatrics, Mazandaran University of Medical Sciences, Sari
  • Hasan Karami Departments of Pediatrics, Mazandaran University of Medical Sciences, Sari
  • Seyyed Abbas Hashemi Department of Internal Medicine, Mazandaran University of Medical Sciences, Sari




Probiotics, colic, infantile.


Aim: This study examined the impact of probiotics on children's colic in breast-fed infants.

Methods: This study was a randomized single-blind clinical trial. 100 infants were referred to pediatric gastroenterology clinic of Avicenna diagnosed by gastroenterologist of children who suffered from infantile colic and they were qualified after justifying parents and obtaining written consent. (IRCT registration number: IRCT2016082829573N1).

Results: Results showed that there was a statistically significant difference in terms of crying time (p = 0.000) and the arrival and departure of the group. (p = 0.000).

Conclusion: The outcomes indicated that using probiotics could reduce colic in infants and improve the quality of life in this group.


[1] Steutel NF, Benninga MA, Langendam MW, de Kruijff I, Tabbers MM. Reporting Outcome Measures in Trials of Infant Colic: A Systematic Review. Journal of Pediatric Gastroenterology and Nutrition 2014.
[2] Savino F, Tarasco V, Sorrenti M, Lingua C, Moja L, Gordon M, et al. Dietary modifications for infantile colic. The Cochrane Library 2014.
[3] Savino F, Cresi F, Pautasso S, Palumeri E, Tullio V, Roana J, et al. Intestinal microflora in breastfed colicky and non?colicky infants. Acta Paediatrica 2004; 93: 825-829.
[4] Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics 2007; 119: e124-e130.
[5] Saavedra JM, Abi-Hanna A, Moore N, Yolken RH. Long-term consumption of infant formulas containing live probiotic bacteria: tolerance and safety. The American Journal of Clinical Nutrition 2004; 79: 261-267.
[6] Rosen LD. “The Gripe”: An Integrative Approach to Infant Colic. Explore: The Journal of Science and Healing 2007; 3: 417-422.
[7] Connolly E, Mollstam B. Use of selected lactic acid bacteria for reducing infantile colic. In: Google Patents; 2007.
[8] Barr RG, Rotman A, Yaremko J, Leduc D, Francoeur TE. The crying of infants with colic: a controlled empirical description. Pediatrics 1992; 90: 14-21.
[9] Brazelton TB. Crying and colic. Helping Parents Solve Their Children's Behavior Problems 1998; 239.
[10] Schrezenmeir J, de Vrese M. Probiotics, prebiotics, and synbiotics—approaching a definition. The American journal of clinical nutrition 2001; 73: 361s-364s.
[11] Ouwehand AC, Derrien M, de Vos W, Tiihonen K, Rautonen N. Prebiotics and other microbial substrates for gut functionality. Current Opinion in Biotechnology 2005; 16: 212-217.
[12] Preidis GA, Versalovic J. Targeting the human microbiome with antibiotics, probiotics, and prebiotics: gastroenterology enters the metagenomics era. Gastroenterology 2009; 136: 2015-2031.
[13] Saavedra J, Tschernia A. Human studies with probiotics and prebiotics: clinical implications. British Journal of Nutrition 2002; 87: S241-S246.
[14] Andersson H, Asp N-G, Bruce Å, Roos S, Wadström T, Wold AE. Health effects of probiotics and prebiotics. A literature review on human studies. Food & Nutrition Research 2001; 45: 58-75.
[15] Savino F, Bailo E, Oggero R, Tullio V, Roana J, Carlone N, et al. Bacterial counts of intestinal Lactobacillus species in infants with colic. Pediatric Allergy and Immunology 2005; 16: 72-75.
[16] Savino F. Focus on infantile colic. Acta Paediatrica 2007; 96: 1259-1264.
[17] Sung V, Hiscock H, Tang M, Mensah FK, Heine RG, Stock A, et al. Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial. BMC Pediatrics 2012; 12: 135.






General Articles