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

Philippe Marteau ^1*, Marc Lémann ², Philippe Seksik ³, David Laharie ⁴, Jean Frédéric Colombel ⁵, Yoram Bouhnik ⁶, Guillaume Cadiot ⁷, Jean Claude Soulé ⁸, Arnaud Boureille ⁹, Etienne Metman ¹⁰, Eric Lerebours ¹¹, Franck Carbonnel ¹², Jean Louis Dupas ¹³, Michel Veyrac ¹⁴, Benoit Coffin ¹⁵, Jacques Moreau ¹⁶, Vered Abitbol ¹⁷, Stéphanie Blum-Sperisen ¹⁸ and Jean Yves Mary ¹⁹

¹ HEGP, Paris, France
² Hôpital St Louis, Paris, France
³ Hôpital St Antoine, Paris, France
⁴ Hôpital Haut-Lévêque, Pessac, France
⁵ Hôpital Claude Huriez, Lille, France
⁶ Hôpital Lariboisiére, Paris, France
⁷ Hôpital Robert Debré, Reims, France
⁸ Hôpital Bichat, Paris, France
⁹ Hôpital Dieu, Nantes, France
¹⁰ Hôpital Trousseau Tours, France
¹¹ Hôpital Charles Nicolle, Rouen, France
¹² Hôpital Jean Minjoz, Besançon, France
¹³ Hôpital Nord, Amiens, France
¹⁴ Hôpital Saint-Eloi, Montpellier, France
¹⁵ Hôpital Louis Mourier, Colombes, France
¹⁶ Hôpital Rangueil, Toulouse, France
¹⁷ Hôpital Cochin, Paris, France
¹⁸ Nestle Research Centre, Vevey, Switzerland
¹⁹ INSERM U717, Biostatistics and Clinical Epidemiology, Hôpital Saint-Louis,, France

^* To whom correspondence should be addressed. E-mail: philippe.marteau{at}egp.ap-hop-paris.fr.

Accepted 25 October 2005

Abstract

BACKGROUD AND AIMS: Early endoscopic recurrence is frequent after intestinal resection for Crohn's disease. Bacteria are involved, and probiotics might 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 randomized double- blind, placebo-controlled study. Patients were eligible if they had undergone surgical resection <1 m removing all macroscopic lesions within the past 21 days. Patients were randomized to receive two packets per day of lyophilized LA1 (2 x 109 cfu) or placebo for 6 months; no other treatment was allowed. The primary endpoint was endoscopic recurrence at 6 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 6 months, endoscopic recurrence was observed in 30/47 patients (64%) in the placebo group, and 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 x 109 cfu/day) did not have a sufficient effect, if any, to prevent endoscopic recurrence of Crohn's disease.

Keywords: Crohn's disease, lactobacillus, postoperative recurrence, probiotics, randomised controlled trial

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