P230 Open label pilot study: an enzyme-rich malt extract (ERME™) for the treatment of chronic constipation

Abstract

<h3>Introduction</h3> The first line treatment for constipation is centred on fibre including increasing dietary fibre and/or fibre supplements. However, fermentable fibres can exacerbate other gastrointestinal (GI) symptoms, such as abdominal pain and bloating. ERME™, an enzyme-rich malt extract, is a food supplement which has been shown to reduce GI fermentation levels, but the effects of ERME™ on symptoms of constipation are unknown. <h3>Methods</h3> 20 patients with chronic constipation were recruited for an open label, pilot study. Chronic constipation was determined by a Knowles-Eccersley-Scott Symptom (KESS) questionnaire score of ≥9. At baseline, patients completed a 1-week daily stool and symptom diary and fasted methane breath samples. Patients then took ERME™ (15ml, twice daily, with food) for 4-weeks, whilst continuing to complete a daily stool and symptom diary. After 4-weeks of ERME™, repeat KESS questionnaire and fasted methane breath samples were collected. Mean values were compared from baseline (Week 0) and Week 4 using paired sample t-tests. <h3>Results</h3> 15 patients successfully completed the study. After 4-weeks of ERME™, the overall constipation (KESS) score significantly reduced (18.9 ±4.06 vs 12.8 ±6.06, p &lt;0.001) and stool consistency significantly improved (2.6 ±0.90 vs 4.2 ±0.91, p = 0.003) from baseline. The number of weekly bowel movements (WBM) was not different (7.8 ±5.83 vs 9.6 ±4.01, p = 0.08), but subgroup analysis in patients (10/15) with ≤1 daily bowel movement showed a significant increase in WBM from baseline (4.6 ±2.3 vs 8.2 ±2.8, p = 0.006). Daily symptom scores (visual analog scale of 0–3) significantly reduced from Week 0 to Week 4 for abdominal pain (0.8 ±0.66 vs 0.5 ±0.62, p = 0.036) and bloating (1.0 ±0.82 vs 0.6 ±0.70, p = 0.002). 53.3% (8/15) of patients were excessive methane producers, but fasted breath methane levels were not different from baseline (p = 0.103). No adverse GI events were reported. Reasons for drop-out included unable to tolerate the taste of ERME™, antibiotic use, and loss to follow up. <h3>Conclusion</h3> ERME™ is a safe and effective treatment for chronic constipation. This pilot study may be used to power larger, randomised controlled trials of ERME™ in patients with constipation.