Pre-biotics and Probiotics for Constipation in Parkinson's Disease

Not Applicable

Completed

• Conditions: Constipation
• Interventions: Other: Placebo; Other: Probiotics and prebiotic

• Registration Number: NCT02459717
• Lead Sponsor: Emanuele Cereda

Brief Summary

Constipation is the most frequent (prevalence, about 60%) dysautonomic non motor symptom affecting Parkinson's disease (PD) patients. Unfortunately, limited treatment options have been investigated and are now available for the management of constipation in PD. Preliminary data have suggested that probiotics could be help improving bowel habits but high-quality randomized trials are required in this area. Therefore, the investigators designed a randomized trial to evaluate whether the use of a fermented milk containing multiple probiotics strains and prebiotic fiber have a beneficial effect on constipation in PD compared to placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-05-28
• Study Start: 2015-06
• Study First Posted: 2015-06-02
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• diagnosis of constipation according to Roma III criteria
• complete bowel movements per week <3
• total bowel movements per week <6
• written informed consent

Exclusion Criteria

• report of loose (mushy) or watery stool in the absence of laxative use
• ongoing artificial nutrition
• lactose intolerance
• chronic inflammatory bowel disease
• previous abdominal surgery
• use of anti-cholinergics
• use of antibiotics in the 6 weeks before baseline visit
• Radio- chemotherapy
• Cognitive decline (Mini Mental State Examination <27)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	pasteurized fermented milk (125 grams) without prebiotics
Probiotics and prebiotic	Probiotics and prebiotic	fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber

Primary Outcome Measures

Name	Time	Method
Complete bowel movements	4 weeks	Change in the mean number of complete spontaneous bowel movements

Secondary Outcome Measures

Name	Time	Method
Stool consistency	4 weeks	Change in mean stool consistency (scored with the use of the 7-point Bristol Stool Form Scale)
Number of bowel movements	4 weeks	Change in the mean number of spontaneous bowel movements
Treatment satisfaction	4 weeks	Satisfaction with the trial medication's ability to relieve constipation symptoms as assessed by a self-rating scale
Frequency of three or more complete bowel movements	4 weeks	Percentage of patients reporting three or more complete bowel movements
Laxative use	4 weeks	Change in the mean use of laxative
Treatment continuation	4 weeks	Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale
Increase in one or more complete bowel movements	4 weeks	Percentage of patients reporting an increase in one or more complete bowel movements

Trial Locations

Locations (1)

IRCCS Istituto Neurologico Mondino; 🇮🇹 Pavia, Italy