Comparing Partially Hydrolyzed Formula With Added Prebiotics Versus Standard Formula for Reducing Infant Colic Episodes
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Background: Infantile colic causes prolonged crying and caregiver distress, while the effectiveness of specialized infant formulas remains uncertain. Objective: To compare partially hydrolyzed whey protein formula supplemented with prebiotics against standard formula for reducing infantile colic symptoms and improving maternal sleep quality. Methods: This double-blind, parallel-group randomized controlled trial was conducted in Islamabad–Rawalpindi, Pakistan, between May 2025 and January 2026. Ninety full-term infants aged 2–6 weeks with colic were randomized equally to receive partially hydrolyzed formula containing galacto-oligosaccharides and fructo-oligosaccharides or standard intact-protein formula for four weeks. Outcomes included daily crying duration, colic episode frequency, and maternal Pittsburgh Sleep Quality Index (PSQI) scores. Data were evaluated using t-tests, repeated measures ANOVA, and Pearson correlation. Results: Eighty-five infants completed follow-up (intervention: n=43; control: n=42). Daily crying duration was lower in the intervention group (1.42 ± 0.44 vs. 2.64 ± 0.62 hours/day; mean difference −1.22; 95% CI −1.45 to −0.99; p<0.001). Colic episodes (1.84 ± 0.72 vs. 3.12 ± 0.91; p<0.001) and maternal PSQI scores (6.81 ± 1.42 vs. 9.34 ± 1.85; p<0.001) also favored the intervention. Conclusion: The specialized formula was associated with reduced colic symptoms and better maternal sleep scores after four weeks. Larger trials with comprehensive safety assessment are warranted
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1. Wolke D, Bilgin A, Samara M. Systematic review and meta-analysis: fussing and crying durations and prevalence of colic in infants. J Pediatr. 2017;185:55-61.e4. doi:10.1016/j.jpeds.2017.02.020.
2. Zeevenhooven J, Koppen IJ, Benninga MA. The diagnosis and management of functional gastrointestinal disorders in infants and toddlers. Early Hum Dev. 2020;147:105028.
3. Vandenplas Y, Cruchet S, Faure C, Lee HC, Di Lorenzo C, Marion G, et al. When should an infant formula be prescribed? A practical guide for clinicians. J Pediatr Gastroenterol Nutr. 2023;76(4):511-523.
4. Savino F, Garro M, Montanari P, Tarasco V, Locatelli E, Di Nardo G. Crying time and gastric emptying in infants with colic fed with a partially hydrolyzed formula: a randomized controlled trial. Nutrients. 2021;13(9):3144.
5. Salvatore S, Agosti M, Baldassarre ME, D'Auria E, Pensabene L, Dituri F, et al. Cow's milk allergy or infantile colic: a diagnostic dilemma. World J Pediatr. 2021;17(5):465-472.
6. Cruchet S, Chouraqui JP, Marteano O, Garcia-Alloza S. Efficacy of a partially hydrolyzed formula with prebiotics in functional gastrointestinal disorders of infancy. Minerva Pediatr. 2020;72(3):191-201.
7. Hegar B, Alatas FS, Advani N, Sungkar A, Vandenplas Y. Infantile colic: management and nutritional dietary interventions. J Korean Med Sci. 2022;37(24):e185.
8. Szajewska H, Dryja G, Pieścik-Lech M, Horvath A, van Goudoever JB. Synbiotics, prebiotics, and probiotics for the treatment of infantile colic: a systematic review. Nutrition. 2023;108:111942.
9. Steutel NF, Zeevenhooven J, Scarpato E, Vandenplas Y, Tabbers MM, Benninga MA. Prevalence of functional gastrointestinal disorders in European infants and toddlers using Rome IV criteria. J Pediatr. 2020;221:107-114.
10. Meyer R, Groetch M, Venter C. Dietary management of infantile colic: an update for pediatric practitioners. Curr Pediatr Rep. 2024;12(1):45-56.
11. Indrio F, Dargenio R, Giordano P, Francavilla R. Intestinal microbiota and functional gastrointestinal disorders in children: an unmapped territory. Front Psychiatry. 2022;13:892045.
12. Belkind-Gerson J, Powell N, Moore DJ. Visceral hypersensitivity and gut motility changes in colicky infants: a clinical overview. Neurogastroenterol Motil. 2021;33(8):e14112.
13. Thapar N, Benninga MA, Crowell MD, Di Lorenzo C, Mack D, Nurko S, et al. Paediatric functional gastrointestinal disorders: Rome IV to Rome V perspectives. Lancet Gastroenterol Hepatol. 2023;8(7):658-670.
14. Gerasimidis K, Bryden K, Jenkins JA, Edwards CA. The effect of protein hydrolysates on gut microenvironment parameters and transient fermentation gas. Am J Clin Nutr. 2020;112(4):985-994.
15. Karas J, Ashby D, Lindley KJ. Oligosaccharide supplementation in routine infant nutrition: a comparative review of bifidogenic effects. J Hum Nutr Diet. 2021;34(5):812-824.
16. Pärtty A, Kalliomäki M, Isolauri E. Probiotics, prebiotics, and the infant gut microbiota: perspectives on colic resolution. Pediatr Res. 2020;88(Suppl 1):34-39.
17. Iacovou M, Craig SS, Yelland L, Muir JG, Gibson PR. Infant feeding practices and their association with colic symptoms: a regional cohort study. J Paediatr Child Health. 2022;58(6):1011-1018.
18. Hall B, Chebar Lozinsky A, Skrapac AC. Validity and reliability of parent-reported infant behavior diaries in clinical trials. Infant Behav Dev. 2023;71:101825.