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

Constipation Clinical Trial

Official title:

Double Blind, Placebo-controlled Trial of a Fermented Milk Containing Multiple Probiotics Strains and Prebiotic Fiber for Constipation Associated With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459717
• Other study ID #: 66/INT/2015
• Status: Completed
• Phase: N/A
• First received: May 26, 2015
• Last updated: October 1, 2015
• Start date: June 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Parkinson Disease

Intervention

Other:
• Probiotics and prebiotic
Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber
• Placebo
Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics)

Locations

Country	Name	City	State
Italy	IRCCS Istituto Neurologico Mondino	Pavia

Sponsors (3)

Lead Sponsor	Collaborator
Emanuele Cereda	IRCCS Istituto Neurologico Mondino, Pavia, Italy, Istituti Clinici di Perfezionamento di Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete bowel movements	Change in the mean number of complete spontaneous bowel movements	4 weeks	No
Secondary	Number of bowel movements	Change in the mean number of spontaneous bowel movements	4 weeks	No
Secondary	Stool consistency	Change in mean stool consistency (scored with the use of the 7-point Bristol Stool Form Scale)	4 weeks	No
Secondary	Laxative use	Change in the mean use of laxative	4 weeks	No
Secondary	Treatment satisfaction	Satisfaction with the trial medication's ability to relieve constipation symptoms as assessed by a self-rating scale	4 weeks	No
Secondary	Treatment continuation	Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale	4 weeks	No
Secondary	Increase in one or more complete bowel movements	Percentage of patients reporting an increase in one or more complete bowel movements	4 weeks	No
Secondary	Frequency of three or more complete bowel movements	Percentage of patients reporting three or more complete bowel movements	4 weeks	No