Probiotics in Elderly Patients With Medical Conditions

National University of Malaysia (UKM)

Status: Completed

Conditions: Aging; Constipation; Multi-Core Disease

Treatments: Dietary Supplement: microbial cell preparation [MCP]; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04035616

FF-2016-417)

NMRR-19-1761-49477 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo were manufactured and supplied by B-Crobes Laboratory Sdn. Bhd. as powder in identical sachets with active comparator and labelled as A

Treatment:

Other: placebo

Hexbio® MCP

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: microbial cell preparation [MCP]