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
- P Marteau1,
- M Lémann2,
- P Seksik3,
- D Laharie4,
- J F Colombel5,
- Y Bouhnik6,
- G Cadiot7,
- J C Soulé8,
- A Bourreille9,
- E Metman10,
- E Lerebours11,
- F Carbonnel12,
- J L Dupas13,
- M Veyrac14,
- B Coffin15,
- J Moreau16,
- V Abitbol17,
- S Blum-Sperisen18,
- J Y Mary19
- 1Department of Gastroenterology, Hôpital Européen Georges Pompidou, Paris, France
- 2Department of Gastroenterology, Hôpital Saint-Louis, Paris, France
- 3Department of Gastroenterology, Hôpital Saint-Antoine, Paris, France
- 4Department of Gastroenterology, Hôpital Haut-Lévêque, Pessac, France
- 5Department of Gastroenterology, Hôpital Claude Huriez, CH et U Lille, France
- 6Department of Gastroenterology, Hôpital Lariboisière, Paris, France
- 7Department of Gastroenterology, Hôpital Robert Debré, Reims, France
- 8Department of Gastroenterology, Hôpital Bichat, Paris, France
- 9Department of Gastroenterology, Hôtel Dieu, Nantes, France
- 10Department of Gastroenterology, Hôpital Trousseau Tours, France
- 11Department of Gastroenterology, Hôpital Charles Nicolle, Rouen, France
- 12Department of Gastroenterology, Hôpital Jean Minjoz, Besançon, France
- 13Department of Gastroenterology, Hôpital Nord, Amiens, France
- 14Department of Gastroenterology, Hôpital Saint-Eloi, Montpellier, France
- 15Department of Gastroenterology, Hôpital Louis Mourier, Colombes, France
- 16Department of Gastroenterology, Hôpital Rangueil, Toulouse, France
- 17Department of Gastroenterology, Hôpital Cochin, Paris, France
- 18Nestle Research Centre, Vevey, Switzerland
- 19INSERM U717, Biostatistics and Clinical Epidemiology, Hôpital Saint-Louis, Université Paris, France
- 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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Gut 2006; 55 757-759 Published Online First: 11 May 2006. doi: 10.1136/gut.2005.085381