Probiotics in Elderly Patients With Medical Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy of a Probiotic for Functional Constipation (FC)

NCT06083311

Functional Constipation

COMPLETED NA

Probiotics Alleviate Functional Constipation in Adults

NCT06879587

Constipation

COMPLETED NA

Efficacy of Probiotic Against Functional Constipation

NCT06122558

Constipation - Functional

RECRUITING PHASE2

Multi-strain Probiotic Effects on Self-Reported Constipation

NCT07275866

Constipation Probiotic Probiotic Intervention

RECRUITING NA

Effects of Synbiotics on FC and Other Contributing Factors

NCT04620317

Functional Constipation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aging Constipation Multi-Core Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The subjects received either the probiotics or a placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

inactive ingredient

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.

Group Type ACTIVE_COMPARATOR

microbial cell preparation [MCP]

Intervention Type DIETARY_SUPPLEMENT

active microbial cell preparation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

microbial cell preparation [MCP]

active microbial cell preparation

Intervention Type DIETARY_SUPPLEMENT

placebo

inactive ingredient

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hexbio®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No