Probiotics in Elderly Patients With Medical Conditions

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Efficacy of Probiotics in Treating Constipation in Elderly Patients With Multiple Chronic Co-morbidities: a Randomized Control Trial

Conditions
-----------------
Aging, Constipation, Multi-Core Disease

Intervention / Treatment
-----------------
* Dietary Supplement: microbial cell preparation [MCP]
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The subjects received either the probiotics or a placebo.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo were manufactured and supplied by B-Crobes Laboratory Sdn. Bhd. as powder in identical sachets with active comparator and labelled as A | Other: placebo<br>* inactive ingredient<br>|
| Active Comparator: Hexbio® MCP<br>The treatment sample is labelled as B.This is an orange-flavoured, granulated microbial cell preparation containing 30 billion colony forming units (cfu) of Lactobacilli and Bifidobacteria strains: Lactobacillus acidophilus BCMC® 12130, Lactobacillus casei BCMC® 12313, Lactobacillus lactis BCMC® 12451, Bifidobacterium bifidum BCMC® 02290, Bifidobacterium infantis BCMC®02129, Bifidobacterium longum BCMC® 02120. The placebo sample was similar in appearance and taste, but contained no microbial cells. | Dietary Supplement: microbial cell preparation [MCP]<br>* active microbial cell preparation<br>* Other names: Hexbio®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in stool output frequency | numerical scale 0-100 used, 0= nil (worst), 100= good, medium score was used for data interpratation | 7 days | 
| changes in stool consistency | 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 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients' perceptions of an improvement in their constipation-related symptoms 1 | straining: likert score of 0 to 10 was used, 0=no straining, 10= worst straining | 7 days | 
| patients' perceptions of an improvement in their constipation-related symptoms 2 | sensation of incomplete evacuation: likert score of 0 to 10 was used, 0= total incomplete evacuation, 10=complete evacuation | 7 days | 
| patients' perceptions of an improvement in their constipation-related symptoms 3 | sensation of ano-rectal obstruction/blockage: likert score of 0 to 10 was used, 0=complete obstruction, 10= complete relieved | 7 days | 
| patients' perceptions of an improvement in their constipation-related symptoms 4 | Need of manual evacuation to aid defeacation: likert score of 0 to 10 was used, 0=no evacuation needed, 10=total evacuation needed | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microbial cell preparation, Hexbio®, probiotics, elderly, chronic medical conditions, constipation,