M Y A Ghafar1, H Yaakup, R A R Ali, S A Shah. 1. Dr. Hayati Yaakup, Palliative Care Unit, Department of Internal Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latiff, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, Malaysia, Tel: +60391456074, Fax: +60391456692, Email: rati98@hotmail.com.
Abstract
OBJECTIVES: To evaluate the impact of a microbial cell preparation (MCP®) (Hexbio®; comprising MCP® BCMC® strains) on stool frequency, consistency, and constipation-related symptoms in elderly patients with multiple chronic medical conditions. DESIGN: Randomised control trial. SETTING:Medical outpatient and medical/surgical in-patient unit in single tertiary center. PARTICIPANT: Patients aged ≥ 60 years who experience constipation and have multiple chronic medical conditions. METHODS:Participants with constipation were blindly randomized into either a treatment (MCP® BCMC® strains) or a placebo group. The treatment was administered twice daily. MEASUREMENT: Gastrointestinal symptoms and stool habits were assessed over a week during the intervention via the use of a questionnaire and stool diary. RESULTS:Stool frequency was seen to be higher and the improvement in stool consistency was more significant in the treatment group than in the placebo group (p =<0.001). A significant improvement in symptoms was demonstrated in patients who received MCP® BCMC® strains,specifically with respect to straining (p = < 0.001) and a sensation of incomplete evacuation (p = < 0.001). reduction in anorectal blockage symptoms and the need for manual stool evacuation was also demonstrated, but this finding was not statistically significant. Significant adverse events were not observed. CONCLUSIONS: An improvement in stool frequency and consistency was reported in elderly patients with chronic medical conditions following the administration of MCP® BCMC® strains.
RCT Entities:
OBJECTIVES: To evaluate the impact of a microbial cell preparation (MCP®) (Hexbio®; comprising MCP® BCMC® strains) on stool frequency, consistency, and constipation-related symptoms in elderly patients with multiple chronic medical conditions. DESIGN: Randomised control trial. SETTING: Medical outpatient and medical/surgical in-patient unit in single tertiary center. PARTICIPANT: Patients aged ≥ 60 years who experience constipation and have multiple chronic medical conditions. METHODS:Participants with constipation were blindly randomized into either a treatment (MCP® BCMC® strains) or a placebo group. The treatment was administered twice daily. MEASUREMENT: Gastrointestinal symptoms and stool habits were assessed over a week during the intervention via the use of a questionnaire and stool diary. RESULTS: Stool frequency was seen to be higher and the improvement in stool consistency was more significant in the treatment group than in the placebo group (p =<0.001). A significant improvement in symptoms was demonstrated in patients who received MCP® BCMC® strains,specifically with respect to straining (p = < 0.001) and a sensation of incomplete evacuation (p = < 0.001). reduction in anorectal blockage symptoms and the need for manual stool evacuation was also demonstrated, but this finding was not statistically significant. Significant adverse events were not observed. CONCLUSIONS: An improvement in stool frequency and consistency was reported in elderly patients with chronic medical conditions following the administration of MCP® BCMC® strains.