Once daily high dose probiotic therapy (VSL#3) for maintaining remission in recurrent or refractory pouchitis

• Published in: Gut 2004-01, Vol.53 (1), p.108-114
• Main Authors: Mimura, T, Rizzello, F, Helwig, U, Poggioli, G, Schreiber, S, Talbot, I C, Nicholls, R J, Gionchetti, P, Campieri, M, Kamm, M A
• Format: Article
• Language: English
• Subjects: Adult; Antibiotics; Biological and medical sciences; Ciprofloxacin - therapeutic use; Cytokines; Drug Therapy, Combination; Endoscopy; Feces - microbiology; Female; Gangrene; Gastroenterology. Liver. Pancreas. Abdomen; Humans; IBDQ; ileal pouch anal anastomosis; Inflammation; Inflammatory Bowel Disease; inflammatory bowel disease questionnaire; IPAA; Male; Medical sciences; Metronidazole - therapeutic use; Middle Aged; Ostomy; Patient Satisfaction; PDAI; Pharmacists; pouchitis; Pouchitis - drug therapy; Pouchitis - rehabilitation; pouchitis disease activity index; Probiotics; Probiotics - adverse effects; Probiotics - therapeutic use; QOL; Quality of Life; Recurrence; Remission Induction; Rodents; Severity of Illness Index; Tumor necrosis factor-TNF; VSL#3
• ISSN: 0017-5749; 1468-3288; 1458-3288
• DOI: 10.1136/gut.53.1.108

Background: Ten to 15% of patients with pouchitis experience refractory or recurrent disease. The aim of this study was to evaluate the effectiveness of a single daily high dose probiotic preparation (VSL#3) in maintaining antibiotic induced remission, and quality of life (QOL), for one year in such patients. Methods: Patients with pouchitis at least twice in the previous year or requiring continuous antibiotics, associated with a pouchitis disease activity index (PDAI) ⩾7 (0 = perfect; 18 = worst), in whom remission was induced by four weeks of combined metronidazole and ciprofloxacin, were randomised to receive VSL#3 6 g or placebo once daily for one year or until relapse. Symptomatic, endoscopic, and histological evaluations were made before, and two and 12 months after randomisation or at the time of relapse. Remission was defined as a clinical PDAI ⩽2 and endoscopic PDAI ⩽1. Relapse was defined as an increased clinical PDAI score ⩾2 and increased endoscopic PDAI score ⩾3. QOL was assessed using the inflammatory bowel disease questionnaire (IBDQ). Results: Thirty six patients were randomised: 20 to VSL#3 and 16 to placebo. Remission was maintained at one year in 17 patients (85%) on VSL#3 and in one patient (6%) on placebo (p