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A Randomized Controlled Trial of Lactobacillus GG in Children With Functional Abdominal Pain
Abstract
OBJECTIVE: Our aim was to determine whether Lactobacillus rhamnosus GG (LGG) relieves symptoms in children with recurrent abdominal pain. PATIENTS AND METHODS: A total of 141 children with irritable bowel syndrome (IBS) or functional pain were enrolled in 9 primary care sites and a referral center. Children entered a randomized, double-blind, placebo-controlled trial and received LGG or placebo for 8 weeks and entered follow-up for 8 weeks. The primary outcome was overall pain at the end of the intervention period. At entry and at the end of the trial, children underwent a double-sugar intestinal permeability test. RESULTS: Compared with baseline, LGG, but not placebo, caused a significant reduction of both frequency (P < .01) and severity (P < .01) of abdominal pain. These differences still were significant at the end of follow-up (P < .02 and P < .001, respectively). At week 12, treatment success was achieved in 48 children in the LGG group compared with 37 children in the placebo group (P < .03); this difference still was present at the end of follow-up (P < .03). At entry, 59% of the children had abnormal results from the intestinal permeability test; LGG, but not placebo, determined a significant decrease in the number of patients with abnormal results from the intestinal permeability testing (P < .03). These effects mainly were in children with IBS. CONCLUSIONS: LGG significantly reduces the frequency and severity of abdominal pain in children with IBS; this effect is sustained and may be secondary to improvement of the gut barrier.
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“and in humans [161,175]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [161]
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Suthivanich, P., Vongseenin, S., Auvichayapat, V., Supronsinchai, W., Tumwasorn, S., Chayanupatkul, M., & Bongsebandhu‐phubhakdi, S. (2025) · Scientific Reports · doi:10.1038/s41598-025-24928-2 · Cited by 1
Treatment of pediatric abdominal pain: what is the evidence?
Saps, M., & Arrizabalo, S. (2025) · Expert Review of Gastroenterology & Hepatology · doi:10.1080/17474124.2025.2592089 · Cited by 1
“Among them, Lactobacillus rhamnosus GG received a conditional recommendation for IBS based on two studies, supported by moderate certainty for reducing pain frequency [10,11].”
Irritable Bowel Syndrome: A Review of Management Strategies
Lebowitz, J., Barash, L., & Perez, M. E. (2026) · Current Treatment Options in Pediatrics · doi:10.1007/s40746-026-00366-8 · Cited by 2
“Two RCTs showed significant reduction in frequency and severity of abdominal pain with lactoba-cillus rhamnosus compared to placebo in pediatric patients with functional abdominal pain [35, 36].”
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Viable and Heat-Inactivated Bifidobacterium bifidum MIMBb75 Protect the Intestinal Barrier
Storr, M., & Gschwender, M. (2026) · Microorganisms · doi:10.3390/microorganisms14061349 · Cited by 1
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Early Nutrition and its Effect on the Development of Functional GI Disorders
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Management of irritable bowel syndrome in children
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Recurring Abdominal Pain in Pediatrics
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“From these data, LGG is effective in reducing the severity of pain in IBS patients [29].”
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Metadata
- Authors
- Francavilla, R., Miniello, V., Magistà, A. M., De Canio, A., Bucci, N., Gagliardi, F., Lionetti, E., Castellaneta, S., Polimeno, L., Peccarisi, L., Indrio, F., & Cavallo, L.
- Affiliations
- Departments of Developmental Biomedicine and
- University of Catania (IT)
- Ospedale San Paolo (IT)
- University of Bari Aldo Moro (IT)
- ASL-Bari, Bari, Italy
- Corresponding author
- Francavilla, Ruggiero
- ORCID
- Venue
- Pediatrics
- Publisher
- American Academy of Pediatrics (AAP)
- Published
- 2010-12-01
- Volume
- 126
- Issue
- 6
- Pages
- e1445-e1452
- ISSN
- 0031-4005 (ISSN-L)
- 1098-4275
- OpenAlex
- W2146310450
- Cited by
- 242
- References
- 46
- Citations by year
- 2026: 6 · 2025: 9 · 2024: 16 · 2023: 10 · 2022: 18 · 2021: 18 · 2020: 13 · 2019: 13 · 2018: 21 · 2017: 18 · 2016: 18 · 2015: 17 · 2014: 20 · 2013: 15 · 2012: 17
- FWCI
- 14.50
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- PEDIATRICS (publishedVersion)
- PubMed (publishedVersion)
- AIRUS (submittedVersion)
- Università Politecnica delle Marche (Università Politecnica delle Marche) (submittedVersion)
- CINECA IRIS Institutional Research Information System (University of Bari Aldo Moro) (submittedVersion)
- 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, probiotics, functional abdominal pain, irritable bowel syndrome, children, intestinal permeability, intestinal barrier
- MeSH terms
- Adolescent, Child, Child, Preschool, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Retrospective Studies, Abdominal Pain, Treatment Outcome, Probiotics, Irritable Bowel Syndrome, Lacticaseibacillus rhamnosus
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