Aging, Constipation, Multi-Core Disease
Conditions
Keywords
microbial cell preparation, Hexbio®, probiotics, elderly, chronic medical conditions, constipation,
Brief summary
Study of efficacy of probiotic in older patients with multiple co-morbidites and constipation
Detailed description
Background and aims: Probiotics are known to have a beneficial effect on the management of constipation. Thus, the current study objective was to evaluate the impact of a microbial cell preparation (MCP) (Hexbio®; comprising Bifidobacterium and Lactobacillus strains) on stool frequency, consistency, and constipation-related symptoms in elderly patients with multiple chronic medical conditions.
Interventions
DIETARY_SUPPLEMENTmicrobial cell preparation [MCP]
active microbial cell preparation
OTHERplacebo
inactive ingredient
Sponsors
Universiti Kebangsaan Malaysia Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Both investigators and patients were unaware of the assignment and were blinded to the labelling process performed by the sample supplier. The patients were randomly allocated to one of two groups; those who received sample labelled A or B. Emergency code break were kept at the manufacturing factory and no code break was needed throughout the trial duration. Both the MCP and placebo were manufactured and supplied by B-Crobes Laboratory Sdn. Bhd. as powder in identical sachets and labelled as A and B. Investigators have no contact with the manufacturing staffs at any point during the trial process. Following data analysis, unblinding was performed to complete the study process.
Intervention model description
The subjects received either the probiotics or a placebo.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-clinical diagnosis of constipation
Exclusion criteria
* Parkinson's disease, * spinal cord lesions * post radiation strictures * on calcium supplements of greater than 1,500 mg per day * immune-deficiency * critical illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in stool output frequency | 7 days | numerical scale 0-100 used, 0= nil (worst), 100= good, medium score was used for data interpratation |
| changes in stool consistency | 7 days | The Bristol Stool scale was used, scale type 1 to 7, type 1 = hard stool and type 7=entirely liquid stool, medium score was used for data intepretation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patients' perceptions of an improvement in their constipation-related symptoms 1 | 7 days | straining: likert score of 0 to 10 was used, 0=no straining, 10= worst straining |
| patients' perceptions of an improvement in their constipation-related symptoms 2 | 7 days | sensation of incomplete evacuation: likert score of 0 to 10 was used, 0= total incomplete evacuation, 10=complete evacuation |
| patients' perceptions of an improvement in their constipation-related symptoms 3 | 7 days | sensation of ano-rectal obstruction/blockage: likert score of 0 to 10 was used, 0=complete obstruction, 10= complete relieved |
| patients' perceptions of an improvement in their constipation-related symptoms 4 | 7 days | Need of manual evacuation to aid defeacation: likert score of 0 to 10 was used, 0=no evacuation needed, 10=total evacuation needed |
Countries
Malaysia
Outcome results
None listed