Probiotics in Elderly Patients With Medical Conditions

Not Applicable

Completed

• Conditions: Aging; Constipation; Multi-Core Disease
• Interventions: Other: placebo; Dietary Supplement: microbial cell preparation [MCP]

• Registration Number: NCT04035616
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

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.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-07
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-24
• Last Update Submitted: 2019-07-24
• Study First Posted: 2019-07-29
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	placebo were manufactured and supplied by B-Crobes Laboratory Sdn. Bhd. as powder in identical sachets with active comparator and labelled as A
Hexbio® MCP	microbial cell preparation [MCP]	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universiti Kebangsaan Malaysia Medical Faculty; 🇲🇾 Kuala lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia