Trial of Probiotics for Constipation in Parkinson's Disease

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-01-31

Brief Summary

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

This is a double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics in the treatment of constipation in Parkinson's disease.

Related Clinical Trials

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

Effect of Probiotic on Constipation in Patients With Parkinson's Disease

NCT04293159

Parkinson Disease Constipation

UNKNOWN NA

An Evaluation of the Effectiveness of a Proprietary Probiotic Blend on Functional Constipation

NCT02418507

Functional Constipation

COMPLETED PHASE2

The Efficacy of a Probiotic for Functional Constipation (FC)

NCT06083311

Functional Constipation

COMPLETED NA

Probiotics in Elderly Patients With Medical Conditions

NCT04035616

Aging Constipation Multi-Core Disease

COMPLETED NA

Treating Anxiety in Parkinson's Disease With a Multi-Strain Probiotic

NCT03968133

Parkinson Disease Anxiety

UNKNOWN PHASE2

Detailed Description

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

Conditions

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

Parkinson 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

Placebo Controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blinded

Study Groups

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

Treatment

Probiotics capsules

Group Type ACTIVE_COMPARATOR

Probiotic Capsule

Intervention Type DRUG

Probiotic - one capsule a day for four weeks

Placebo

Placebo capsules containing maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type DRUG

Placebo - one capsule a day for four weeks

Interventions

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

Probiotic Capsule

Probiotic - one capsule a day for four weeks

Intervention Type DRUG

Placebo Capsule

Placebo - one capsule a day for four weeks

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Age 50 to 80 years old
* Provision of written informed consent
* Diagnosis of PD made by a Neurologist using UK Brain Bank Criteria
* Fulfils criteria for functional constipation according to the Rome IV Criteria during in the preceding 6 months with frequency of bowel movements less than 3 times per week

Exclusion Criteria

* Ingestion of probiotics in the preceding 4 weeks
* Use of antibiotics in the preceding 4 weeks
* History of gastrointestinal disorders or surgery
* Known or suspected allergy to probiotics
* Comorbidities that prevent reliable completion of study assessments
* Prior functional neurosurgery for PD or treatment with apomorphine infusion
* Recent initiation of dopaminergic medications in the preceding 3 months

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No