Probiotics in Elderly Patients With Medical Conditions

Sponsor

Universiti Kebangsaan Malaysia Medical Centre (Other)

Overall Status

Completed

CT.gov ID

NCT04035616

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

25.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aging Constipation Multi-Core Disease	Dietary Supplement: microbial cell preparation [MCP] Other: placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The subjects received either the probiotics or a placebo.The subjects received either the probiotics or a placebo.

Masking:

Double (Participant, 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 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 inactive ingredient
Active Comparator: Hexbio® 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.	Dietary Supplement: microbial cell preparation [MCP] active microbial cell preparation Other Names: Hexbio®

Arm

Intervention/Treatment

Placebo Comparator: Placebo

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

inactive ingredient

Active Comparator: Hexbio® 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.

Dietary Supplement: microbial cell preparation [MCP]

active microbial cell preparation

Other Names:

Hexbio®

Outcome Measures

Primary Outcome Measures

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

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