Randomised clinical trial: efficacy of the Lactobacillus paracasei enriched artichokes in the treatment of patients with functional constipation a double-blind, controlled, crossover study.

Background The role of probiotics in the management of constipation is uncertain. Aims To evaluate the effects of probiotic-enriched artichokes on treatment preference, symptom profile and short-chain fatty acid (SCFA) production in constipated subjects when compared with ordinary artichokes. Methods Twenty constipated patients (3M/17F; 38.8 ± 14.4 years) were studied using a double-blind method and a computer-generated randomisation list. Each patient consumed 180 g per day of ordinary artichokes or artichokes enriched with Lactobacillus paracasei IMPC 2.1 for 15 days (daily dose of 2 X 1010 CFU). Relief of symptoms was evaluated using a visual analogue scale. The stool consistency and symptom profile of patients were investigated using the Bristol stool form chart and the Gastrointestinal Symptom Rating Scale questionnaire (GSRS). SCFA production in faecal samples was evaluated using HPLC. Results Eighty per cent of patients preferred probiotic-enriched artichokes to ordinary ones (P = 0.011). Satisfactory relief of symptoms was significantly higher (P = 0.0014) during the probiotic-enriched artichoke period. Bristol chart cluster scores were significantly higher (3.3 ± 1.2, 2.9 ± 1.3 2.2 ± 1.2, baseline, ordinary artichokes and probiotic-enriched ones, respectively; P = 0.009) and GSRS constipation was significantly lower (13.9 ± 0.9, 10.2 ± 0.8, 8.3 ± 0.9; P = 0.032) in the probiotic group compared with the baseline. As for SCFA production, propionic acid was significantly higher (2.2 ± 1.4, 2.1 ± 1.53, 1.5 ± 1.2; P = 0.035) in the probiotic group compared with baseline. Conclusion This trial shows a positive effect on symptoms in constipated patients after intake of probiotic-enriched artichokes (clinical trial NCT01212146).