Ineffectiveness of Lactobacillus johnsonii LA1 for prophylaxis of postoperative recurrence in Crohn’s disease: a randomised, double blind, placebo controlled GETAID trial (original) (raw)

Inflammatory bowel disease

Ineffectiveness of Lactobacillus johnsonii LA1 for prophylaxis of postoperative recurrence in Crohn’s disease: a randomised, double blind, placebo controlled GETAID trial

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  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
  20. 1Department of Gastroenterology, Hôpital Européen Georges Pompidou, Paris, France
  21. 2Department of Gastroenterology, Hôpital Saint-Louis, Paris, France
  22. 3Department of Gastroenterology, Hôpital Saint-Antoine, Paris, France
  23. 4Department of Gastroenterology, Hôpital Haut-Lévêque, Pessac, France
  24. 5Department of Gastroenterology, Hôpital Claude Huriez, CH et U Lille, France
  25. 6Department of Gastroenterology, Hôpital Lariboisière, Paris, France
  26. 7Department of Gastroenterology, Hôpital Robert Debré, Reims, France
  27. 8Department of Gastroenterology, Hôpital Bichat, Paris, France
  28. 9Department of Gastroenterology, Hôtel Dieu, Nantes, France
  29. 10Department of Gastroenterology, Hôpital Trousseau Tours, France
  30. 11Department of Gastroenterology, Hôpital Charles Nicolle, Rouen, France
  31. 12Department of Gastroenterology, Hôpital Jean Minjoz, Besançon, France
  32. 13Department of Gastroenterology, Hôpital Nord, Amiens, France
  33. 14Department of Gastroenterology, Hôpital Saint-Eloi, Montpellier, France
  34. 15Department of Gastroenterology, Hôpital Louis Mourier, Colombes, France
  35. 16Department of Gastroenterology, Hôpital Rangueil, Toulouse, France
  36. 17Department of Gastroenterology, Hôpital Cochin, Paris, France
  37. 18Nestle Research Centre, Vevey, Switzerland
  38. 19INSERM U717, Biostatistics and Clinical Epidemiology, Hôpital Saint-Louis, Université Paris, France
  39. 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.

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