Probiotics in Elderly Patients With Medical Conditions

Universiti Kebangsaan Malaysia Medical Centre100 enrolled

Overview

Study of efficacy of probiotic in older patients with multiple co-morbidites and constipation

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Aging Constipation Multi-Core Disease

Interventions

microbial cell preparation [MCP]DIETARY_SUPPLEMENT

active microbial cell preparation

placeboOTHER

inactive ingredient

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Universiti Kebangsaan Malaysia Medical Faculty

Kuala Lumpur, Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

changes in stool output frequency

numerical scale 0-100 used, 0= nil (worst), 100= good, medium score was used for data interpratation

Time frame: 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

Time frame: 7 days

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 7 days

Data from ClinicalTrials.gov

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