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

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ClinicalTrials.gov Identifier: NCT02459717
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : October 2, 2015
Sponsor:
Collaborators:
IRCCS Istituto Neurologico Mondino, Pavia, Italy
Istituti Clinici di Perfezionamento di Milano
Information provided by (Responsible Party):
Emanuele Cereda, IRCCS Policlinico S. Matteo

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.

Condition or disease Intervention/treatment Phase
Constipation Other: Probiotics and prebiotic Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotics and prebiotic
fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber
Other: Probiotics and prebiotic
Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber

Placebo Comparator: Placebo
pasteurized fermented milk (125 grams) without prebiotics
Other: Placebo
Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics)




Primary Outcome Measures :
  1. Complete bowel movements [ Time Frame: 4 weeks ]
    Change in the mean number of complete spontaneous bowel movements


Secondary Outcome Measures :
  1. Number of bowel movements [ Time Frame: 4 weeks ]
    Change in the mean number of spontaneous bowel movements

  2. Stool consistency [ Time Frame: 4 weeks ]
    Change in mean stool consistency (scored with the use of the 7-point Bristol Stool Form Scale)

  3. Laxative use [ Time Frame: 4 weeks ]
    Change in the mean use of laxative

  4. Treatment satisfaction [ Time Frame: 4 weeks ]
    Satisfaction with the trial medication's ability to relieve constipation symptoms as assessed by a self-rating scale

  5. Treatment continuation [ Time Frame: 4 weeks ]
    Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale

  6. Increase in one or more complete bowel movements [ Time Frame: 4 weeks ]
    Percentage of patients reporting an increase in one or more complete bowel movements

  7. Frequency of three or more complete bowel movements [ Time Frame: 4 weeks ]
    Percentage of patients reporting three or more complete bowel movements



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459717


Locations
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Italy
IRCCS Istituto Neurologico Mondino
Pavia, Italy
Sponsors and Collaborators
Emanuele Cereda
IRCCS Istituto Neurologico Mondino, Pavia, Italy
Istituti Clinici di Perfezionamento di Milano
Investigators
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Principal Investigator: Claudio Pacchetti, MD IRCCS Istituto Neurologico Mondino

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emanuele Cereda, Co-project Investigator, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT02459717     History of Changes
Other Study ID Numbers: 66/INT/2015
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Parkinson Disease
Constipation
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms, Digestive
Signs and Symptoms