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Ineffectiveness of Lactobacillus GG as an adjunct to lactulose for the treatment of constipation in children: A double-blind, placebo-controlled randomized trial
Abstract
Objective To determine if Lactobacillus GG (LGG) is an effective adjunct to lactulose for treating constipation in children.Study design Eighty-four children (2-16 years of age) with constipation (<3 spontaneous bowel movements [BMs] per week for at least 12 weeks) were enrolled in a double-blind, randomized placebo-controlled trial in which they received 1 mL/kg/day of 70% lactulose plus 10 9 colony-forming units (CFU) of LGG (experimental group, n = 43) or a placebo (control group, n = 41) orally twice daily for 12 weeks. The primary outcome measure was treatment success, and analyses were performed on an intention-to-treat basis.Results Treatment success, defined as >or=3 spontaneous BMs per week with no fecal soiling, was similar in the control and experimental groups at 12 weeks (28/41 [68%] vs 31/43 [72%], respectively; P = .7) and at 24 weeks (27/41 [65%] vs 27/42 [64%], respectively; P = 1.0]. Groups also did not differ in their mean number of spontaneous BMs per week or episodes of fecal soiling per week at 4, 8, and 12 weeks. Adverse events and overall tolerance did not differ between groups.Conclusion LGG, as dosed in this study, was not an effective adjunct to lactulose in treating constipation in children.
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“Two other studies [18,19] showed no evidence of improvement with constipated children using probiotics.”
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“It was concluded that LGG, as used in this study, was not an effective adjunct to lactulose in treating constipation in children (125).”
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“cillus GG as an adjunct to lactulose for children with constipation failed to show additional therapeutic benefit.(107) Another study”
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“Two other studies [18,19] showed no evidence of improvement with constipated children using probiotics.”
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“In their study using Lactobacillus GG as an adjunct to lactulose, Banaszkiewicz and Szajewska found no additional benefit from the probiotic [53].”
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“In another study, the L. rhamnosus GG (LGG) group received lactulose plus LGG orally twice daily for 12 weeks to treat children with constipation, which did not improve the number of spontaneous bowel movements (BMs) and episodes of fecal soiling (Banaszkiewicz and Szajewska, 2005).”
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“%) in 2-week study period Banaszkiewicz and Szajewska 2005 L. rhamnosus GG Dose: 1 mL/kg/day of 70 % lactulose plus 10 9 CFU/day/24 weeks B. lactis DN-173 010 Dose: 4.25 9 10 9 CFU/125 g/pot/b.i.d./ 3 weeks 0.86 (0.70–1.10)* Non-significant :stool frequency over control Mazlyn et al. 2013 14 L.…”
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“Some studies noted an increase in defecation frequency or a reduction in the need for laxatives [28, 29 ].”
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Sansotta, N., Peroni, D. G., Romano, S. L., Rugiano, A., Vuilleumier, P., & Baviera, G. (2019) · Current Opinion in Pediatrics · doi:10.1097/mop.0000000000000808 · Cited by 23
Probiotics in the management of colonic disorders
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Probiotics, Prebiotics, and Dietary Fiber in the Management of Functional Gastrointestinal Disorders
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“Some authors confirm their positive influence on motor activity in the gastrointestinal system [16], while others report that probiotics are not effective as adjuncts in treating functional constipation [17].”
BackgroundSynbiotic preparation in men suffering from functional constipation: a randomised controlled trial
Fateh, R., Iravani, S., Frootan, M., Saadat, S., & Rasouli, M. (2011) · Swiss Medical Weekly · doi:10.4414/smw.2011.13239 · Cited by 46
Effect of probiotics intake on constipation in children: an umbrella review
Dong, M., Wu, Y., Zhang, M., Chen, P., Zhang, Z., & Wang, S. (2023) · Frontiers in Nutrition · doi:10.3389/fnut.2023.1218909 · Cited by 18
Saneian, H., Tavakkol, K., Adhamian, P., & Gholamrezaei, A. (2013) · Europe PMC (PubMed Central) · Cited by 17
Potential benefits of probiotics – main findings of an in-depth review
Weichselbaum, E. (2010) · British Journal of Community Nursing · doi:10.12968/bjcn.2010.15.3.46897 · Cited by 15
“Lactobacillus rhamnosus GG has so far failed to show a significant effect on constipation (Banaszkiewicz and Szajewska, 2005; Hongisto et al, 2006).”
BackgroundUpdated algorithms for managing frequent gastro-intestinal symptoms in infants
Vandenplas, Y., & Alarcon, P. (2014) · Beneficial Microbes · doi:10.3920/bm2014.0075 · Cited by 17
“The literature about the efficacy of probiotics in infant constipation is ambiguous, since about half of the studies are negative and half are positive (Banaszkiewicz and Szajewska, 2005; Bekkali et al. , 2007; Bu et al. , 2007; Coccurullo et al. , 2010; Guerra et al. , 2011; Tabbers et al. , 2011).”
Probiotics for treatment of chronic constipation in children
Wallace, C., Gordon, M. A., Akobeng, A. K., Saps, M., Llanos‐Chea, A., Febo‐Rodriguez, L., Fifi, A. C., Valdes, L. F., Axelrod, C. H., Langshaw, A. H., et al. (2021) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd014257 · Cited by 14
Potential Targets in Constipation Research: A Review
Ravichandiran, V., Arumugam, S., Bisht, P., Dagar, N., & Kumar, N. (2022) · Current Drug Targets · doi:10.2174/1389450124666221209123541 · Cited by 16
What is the evidence for the use of probiotics in functional disorders?
Quigley, E. M. M. (2008) · Current Gastroenterology Reports · doi:10.1007/s11894-008-0072-1 · Cited by 14
Health benefits of probiotics for the elderly: a review
Baker, H. C., Tran, D. N., & Thomas, L. V. (2009) · Journal of Foodservice · doi:10.1111/j.1748-0159.2009.00147.x · Cited by 15
Rosa, D., Zablah, R. A., & Vázquez-Frías, R. (2024) · Frontiers in Pediatrics · doi:10.3389/fped.2023.1283389 · Cited by 15
Nutritional Aspects of Pediatric Gastrointestinal Diseases
Chio, T. D., Sokollik, C., Peroni, D. G., Hart, L., Simonetti, G. D., Righini‐Grunder, F., & Borrelli, O. (2021) · Nutrients · doi:10.3390/nu13062109 · Cited by 11
“Lactobacillus rhamnosus GG as adjunctive therapy to lactulose and lactobacillus casei rhamnosus Lcr35 did not show a superior effect compared to placebo [70].”
BackgroundLee, K. J., Ryoo, E., Lee, Y. M., Yoon, J. M., Jang, H.-J., Choi, S. Y., Choi, Y. J., Kim, H. J., Chung, J., & Shim, J. O. (2022) · Journal of Neurogastroenterology and Motility · doi:10.5056/jnm21130 · Cited by 10
“rhamnosus GG group.(15) However, other studies have reported beneficial effects of L.”
ResultProbiotics for functional constipation in children: an overview of overlapping systematic reviews
Zhang, Y., Li, A., Qiu, J., Wen, H., Zhang, H., & Sun, X. (2024) · Frontiers in Cellular and Infection Microbiology · doi:10.3389/fcimb.2023.1323521 · Cited by 11
Yang, W.-C., Zeng, B., Liang, C., Hsu, C., Su, K., Wu, Y., Tu, Y., Lin, P., Stubbs, B., Chen, T., et al. (2024) · European Journal of Pediatrics · doi:10.1007/s00431-024-05568-6 · Cited by 10
“Finally, we included nine articles in the NMA (eTable 4) [11, 29–36].”
BackgroundMinas Frescal Cheese as a Probiotic Carrier
Pimentel, T. C., Marcolino, V. A., Barão, C. E., Klososki, S. J., & Rosset, M. (2017) · Reference series in phytochemistry · doi:10.1007/978-3-319-54528-8_66-1 · Cited by 9
Cabré, E. (2011) · e-SPEN the European e-Journal of Clinical Nutrition and Metabolism · doi:10.1016/j.eclnm.2011.01.003 · Cited by 8
Novel and alternative therapies for childhood constipation
Liem, O., Benninga, M. A., Mousa, H. M., & Lorenzo, C. D. (2007) · Current Gastroenterology Reports · doi:10.1007/s11894-007-0021-4 · Cited by 9
Strategies used for childhood chronic functional constipation: the SUCCESS evidence synthesis
Todhunter‐Brown, A., Booth, L., Campbell, P., Cheer, B., Cowie, J., Elders, A., Hagen, S., Jankulak, K., Mason, H., Millington, C., et al. (2024) · Health Technology Assessment · doi:10.3310/pltr9622 · Cited by 13
Functional laxative foods: Concepts, trends and health benefits
Tabrizi, A., Dargahi, R., Ghadim, S. T., Javadi, M., Pirouzian, H. R., Azizi, A., & Rad, A. H. (2020) · Studies in natural products chemistry · doi:10.1016/b978-0-12-817907-9.00011-8 · Cited by 8
Metadata
- Authors
- Banaszkiewicz, A., & Szajewska, H.
- Affiliations
- Medical University of Warsaw (PL)
- Corresponding author
- Szajewska, Hania
- Venue
- The Journal of Pediatrics
- Publisher
- Elsevier BV
- Published
- 2005-03
- Volume
- 146
- Issue
- 3
- Pages
- 364-369
- ISSN
- 0022-3476 (ISSN-L)
- OpenAlex
- W2076373003
- Cited by
- 150
- References
- 18
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 6 · 2023: 3 · 2022: 10 · 2021: 4 · 2020: 4 · 2019: 7 · 2018: 10 · 2017: 5 · 2016: 1 · 2015: 6 · 2014: 14 · 2013: 10 · 2012: 3
- FWCI
- 6.12
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Pediatrics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- Lactobacillus rhamnosus GG, lactulose, pediatric constipation, probiotics, adjunctive therapy, fecal soiling, spontaneous bowel movements, treatment efficacy
- MeSH terms
- Adolescent, Algorithms, Child, Child, Preschool, Constipation, Defecation, Double-Blind Method, Gastrointestinal Agents, Humans, Lactobacillus, Lactulose, Treatment Outcome, Probiotics
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