Trial of Probiotics for Constipation in Parkinson's Disease

University of Malaya

Status: Completed

Conditions: Parkinson Disease

Treatments: Drug: Placebo Capsule; Drug: Probiotic Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03377322

ProbioRCT

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

Probiotics capsules

Treatment:

Drug: Probiotic Capsule

Placebo

Placebo Comparator group

Description:

Placebo capsules containing maltodextrin

Treatment:

Drug: Placebo Capsule