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Ineffectiveness of Lactobacillus johnsonii LA1 for prophylaxis of postoperative recurrence in Crohn’s disease: a randomised, double blind, placebo controlled GETAID trial
  1. P Marteau1,
  2. M Lémann2,
  3. P Seksik3,
  4. D Laharie4,
  5. J F Colombel5,
  6. Y Bouhnik6,
  7. G Cadiot7,
  8. J C Soulé8,
  9. A Bourreille9,
  10. E Metman10,
  11. E Lerebours11,
  12. F Carbonnel12,
  13. J L Dupas13,
  14. M Veyrac14,
  15. B Coffin15,
  16. J Moreau16,
  17. V Abitbol17,
  18. S Blum-Sperisen18,
  19. J Y Mary19
  1. 1Department of Gastroenterology, Hôpital Européen Georges Pompidou, Paris, France
  2. 2Department of Gastroenterology, Hôpital Saint-Louis, Paris, France
  3. 3Department of Gastroenterology, Hôpital Saint-Antoine, Paris, France
  4. 4Department of Gastroenterology, Hôpital Haut-Lévêque, Pessac, France
  5. 5Department of Gastroenterology, Hôpital Claude Huriez, CH et U Lille, France
  6. 6Department of Gastroenterology, Hôpital Lariboisière, Paris, France
  7. 7Department of Gastroenterology, Hôpital Robert Debré, Reims, France
  8. 8Department of Gastroenterology, Hôpital Bichat, Paris, France
  9. 9Department of Gastroenterology, Hôtel Dieu, Nantes, France
  10. 10Department of Gastroenterology, Hôpital Trousseau Tours, France
  11. 11Department of Gastroenterology, Hôpital Charles Nicolle, Rouen, France
  12. 12Department of Gastroenterology, Hôpital Jean Minjoz, Besançon, France
  13. 13Department of Gastroenterology, Hôpital Nord, Amiens, France
  14. 14Department of Gastroenterology, Hôpital Saint-Eloi, Montpellier, France
  15. 15Department of Gastroenterology, Hôpital Louis Mourier, Colombes, France
  16. 16Department of Gastroenterology, Hôpital Rangueil, Toulouse, France
  17. 17Department of Gastroenterology, Hôpital Cochin, Paris, France
  18. 18Nestle Research Centre, Vevey, Switzerland
  19. 19INSERM U717, Biostatistics and Clinical Epidemiology, Hôpital Saint-Louis, Université Paris, France
  1. Correspondence to:
    Professor P Marteau
    Départment Médico-Chirurgical de Pathologie Digestive, Hôpital Lariboisière, 2 Rue Ambroise Paré, 75010 Paris, France; philippe.marteau{at}lrb.aphp.fr

Abstract

Background and aims: Early endoscopic recurrence is frequent after intestinal resection for Crohn’s disease. Bacteria are involved, and probiotics may modulate immune responses to the intestinal flora. Here we tested the probiotic strain Lactobacillus johnsonii LA1 in this setting.

Patients and methods: This was a randomised, double blind, placebo controlled study. Patients were eligible if they had undergone surgical resection of <1 m, removing all macroscopic lesions within the past 21 days. Patients were randomised to receive two packets per day of lyophilised LA1 (2×109 cfu) or placebo for six months; no other treatment was allowed. The primary endpoint was endoscopic recurrence at six months, with grade >1 in Rutgeerts’ classification or an adapted classification for colonic lesions. Endoscopic score was the maximal grade of ileal and colonic lesions. Analyses were performed primarily on an intent to treat basis.

Results: Ninety eight patients were enrolled (48 in the LA1 group). At six months, endoscopic recurrence was observed in 30/47 patients (64%) in the placebo group and in 21/43 (49%) in the LA1 group (p = 0.15). Per protocol analysis confirmed this result. Endoscopic score distribution did not differ significantly between the LA1 and placebo groups. There were four clinical recurrences in the LA1 group and three in the placebo group.

Conclusion:L johnsonii LA1 (4×109 cfu/day) did not have a sufficient effect, if any, to prevent endoscopic recurrence of Crohn’s disease.

  • CD, Crohn’s disease
  • CDAI, CD activity index
  • CRP, C reactive protein
  • ITT, intent to treat
  • PP, per protocol
  • OR, odds ratio
  • AE, adverse events
  • Crohn’s disease
  • randomised controlled trial
  • probiotics
  • lactobacillus

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Footnotes

  • Published online first 23 December 2005

  • This study was initiated, designed, and conducted by the GETAID Study Group. It was funded by grant support from the Nestlé Research Centre, Vevey, Switzerland. Study products were provided by Nestlé. All data analysis and manuscript writing were performed independently by the GETAID Study Group, with no involvement of Nestlé representatives.

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