A randomized, double-blind trial of lactobacillus GG versus placebo in addition to standard maintenance therapy for children with Crohn's disease

Athos Bousvaros, Stefano Guandalini, Robert N. Baldassano, Christine Botelho, Jonathan Evans, George D. Ferry, Barry Goldin, Lori Hartigan, Subra Kugathasan, Joseph Levy, Karen F. Murray, Maria Oliva-Hemker, Joel R. Rosh, Vasundhara Tolia, Anna Zholudev, Jon A. Vanderhoof, Patricia L. Hibberd

Research output: Contribution to journalArticle

265 Citations (Scopus)

Abstract

Probiotics are widely used by patients with Crohn's disease (CD) in an attempt to improve their health, but few controlled studies have been done to evaluate the efficacy of these therapies. We conducted a randomized, placebo-controlled trial of the probiotic Lactobacillus rhamnosus strain GG (LGG) to see if the addition of LGG to standard therapy prolonged remission in children with CD. Concomitant medications allowed in the study included amino-salicylates, 6-mercaptopurine, azathioprine, and low-dose alternate day corticosteroids. Seventy-five children (age range, 5-21 yr) with CD in remission were randomized to either LGG (n = 39) or placebo (n = 36) and followed for up to 2 years. The median time to relapse was 9.8 months in the LGG group and 11.0 months in the placebo group (P = 0.24); 31% (12/39) of patients in the LGG group developed a relapse compared with 6/36 (17%) of the placebo group (P = 0.18). The LGG was well tolerated, with a side effect profile comparable with placebo. This study suggests that LGG does not prolong time to relapse in children with CD when given as an adjunct to standard therapy.

Original languageEnglish (US)
Pages (from-to)833-839
Number of pages7
JournalInflammatory bowel diseases
Volume11
Issue number9
DOIs
StatePublished - Sep 1 2005

Fingerprint

Lactobacillus rhamnosus
Crohn Disease
Placebos
Probiotics
Recurrence
Therapeutics
6-Mercaptopurine
Salicylates
Azathioprine
Adrenal Cortex Hormones
Randomized Controlled Trials
Health

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Gastroenterology

Cite this

Bousvaros, Athos ; Guandalini, Stefano ; Baldassano, Robert N. ; Botelho, Christine ; Evans, Jonathan ; Ferry, George D. ; Goldin, Barry ; Hartigan, Lori ; Kugathasan, Subra ; Levy, Joseph ; Murray, Karen F. ; Oliva-Hemker, Maria ; Rosh, Joel R. ; Tolia, Vasundhara ; Zholudev, Anna ; Vanderhoof, Jon A. ; Hibberd, Patricia L. / A randomized, double-blind trial of lactobacillus GG versus placebo in addition to standard maintenance therapy for children with Crohn's disease. In: Inflammatory bowel diseases. 2005 ; Vol. 11, No. 9. pp. 833-839.
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Bousvaros, A, Guandalini, S, Baldassano, RN, Botelho, C, Evans, J, Ferry, GD, Goldin, B, Hartigan, L, Kugathasan, S, Levy, J, Murray, KF, Oliva-Hemker, M, Rosh, JR, Tolia, V, Zholudev, A, Vanderhoof, JA & Hibberd, PL 2005, 'A randomized, double-blind trial of lactobacillus GG versus placebo in addition to standard maintenance therapy for children with Crohn's disease', Inflammatory bowel diseases, vol. 11, no. 9, pp. 833-839. https://doi.org/10.1097/01.MIB.0000175905.00212.2c

A randomized, double-blind trial of lactobacillus GG versus placebo in addition to standard maintenance therapy for children with Crohn's disease. / Bousvaros, Athos; Guandalini, Stefano; Baldassano, Robert N.; Botelho, Christine; Evans, Jonathan; Ferry, George D.; Goldin, Barry; Hartigan, Lori; Kugathasan, Subra; Levy, Joseph; Murray, Karen F.; Oliva-Hemker, Maria; Rosh, Joel R.; Tolia, Vasundhara; Zholudev, Anna; Vanderhoof, Jon A.; Hibberd, Patricia L.

In: Inflammatory bowel diseases, Vol. 11, No. 9, 01.09.2005, p. 833-839.

Research output: Contribution to journalArticle

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T1 - A randomized, double-blind trial of lactobacillus GG versus placebo in addition to standard maintenance therapy for children with Crohn's disease

AU - Bousvaros, Athos

AU - Guandalini, Stefano

AU - Baldassano, Robert N.

AU - Botelho, Christine

AU - Evans, Jonathan

AU - Ferry, George D.

AU - Goldin, Barry

AU - Hartigan, Lori

AU - Kugathasan, Subra

AU - Levy, Joseph

AU - Murray, Karen F.

AU - Oliva-Hemker, Maria

AU - Rosh, Joel R.

AU - Tolia, Vasundhara

AU - Zholudev, Anna

AU - Vanderhoof, Jon A.

AU - Hibberd, Patricia L.

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N2 - Probiotics are widely used by patients with Crohn's disease (CD) in an attempt to improve their health, but few controlled studies have been done to evaluate the efficacy of these therapies. We conducted a randomized, placebo-controlled trial of the probiotic Lactobacillus rhamnosus strain GG (LGG) to see if the addition of LGG to standard therapy prolonged remission in children with CD. Concomitant medications allowed in the study included amino-salicylates, 6-mercaptopurine, azathioprine, and low-dose alternate day corticosteroids. Seventy-five children (age range, 5-21 yr) with CD in remission were randomized to either LGG (n = 39) or placebo (n = 36) and followed for up to 2 years. The median time to relapse was 9.8 months in the LGG group and 11.0 months in the placebo group (P = 0.24); 31% (12/39) of patients in the LGG group developed a relapse compared with 6/36 (17%) of the placebo group (P = 0.18). The LGG was well tolerated, with a side effect profile comparable with placebo. This study suggests that LGG does not prolong time to relapse in children with CD when given as an adjunct to standard therapy.

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