ConstipationNCT02459717
Pre-biotics and Probiotics for Constipation in Parkinson's Disease
A study testing Probiotics and prebiotic in people with Constipation, run by Emanuele Cereda at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Constipation
- What is being tested?
- Probiotics and prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of constipation according to Roma III criteria
- complete bowel movements per week <3
- total bowel movements per week <6
- written informed consent
Who cannot join
- 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
Show all 9Show fewer
- use of antibiotics in the 6 weeks before baseline visit
- Radio- chemotherapy
- Cognitive decline (Mini Mental State Examination <27)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Constipation
- Being tested
- Probiotics and prebiotic, Placebo
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics and prebioticOther
Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber
PlaceboOther
Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics)
| Study group | Role | What they receive |
|---|---|---|
| Probiotics and prebiotic | Experimental | fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber Receives: Other: Probiotics and prebiotic |
| Placebo | Placebo comparator | pasteurized fermented milk (125 grams) without prebiotics Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete bowel movements
Change in the mean number of complete spontaneous bowel movements
Measured: 4 weeks
Secondary outcomes (7)
Number of bowel movements
Change in the mean number of spontaneous bowel movements
Measured: 4 weeks
Stool consistency
Change in mean stool consistency (scored with the use of the 7-point Bristol Stool Form Scale)
Measured: 4 weeks
Laxative use
Change in the mean use of laxative
Measured: 4 weeks
Treatment satisfaction
Satisfaction with the trial medication's ability to relieve constipation symptoms as assessed by a self-rating scale
Measured: 4 weeks
Treatment continuation
Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale
Measured: 4 weeks
Increase in one or more complete bowel movements
Percentage of patients reporting an increase in one or more complete bowel movements
Measured: 4 weeks
Frequency of three or more complete bowel movements
Percentage of patients reporting three or more complete bowel movements
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emanuele Cereda
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS National Neurological Institute "C. Mondino" Foundation, Istituti Clinici di Perfezionamento di Milano
- Responsible party
- Sponsor-investigator, Emanuele Cereda, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Claudio Pacchetti, MD, Principal investigator, IRCCS Istituto Neurologico Mondino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459717
- Sponsor's protocol ID
- 66/INT/2015
- Status last verified
- Oct 2015
- First submitted
- 26 May 2015
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Todd CL, Johnson EE, Stewart F, Wallace SA, Bryant A, Woodward S, Norton C. Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2024 Oct 29;10(10):CD002115. doi: 10.1002/14651858.CD002115.pub6.
PubMed 39470206Barichella M, Pacchetti C, Bolliri C, Cassani E, Iorio L, Pusani C, Pinelli G, Privitera G, Cesari I, Faierman SA, Caccialanza R, Pezzoli G, Cereda E. Probiotics and prebiotic fiber for constipation associated with Parkinson disease: An RCT. Neurology. 2016 Sep 20;87(12):1274-80. doi: 10.1212/WNL.0000000000003127. Epub 2016 Aug 19.
PubMed 27543643
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02459717
- Acronym / sponsor ID
- 66/INT/2015
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Emanuele CeredaUniversity, hospital or other
- Collaborators
- IRCCS National Neurological Institute "C. Mondino" Foundation, Istituti Clinici di Perfezionamento di Milano
- Study start
- Jun 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics and prebiotic | Experimental | Other: Probiotics and prebioticfermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber |
| Placebo | Placebo comparator | Other: Placebopasteurized fermented milk (125 grams) without prebiotics |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of constipation according to Roma III criteria
- complete bowel movements per week <3
- total bowel movements per week <6
- written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics and prebioticPatients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber | Other | Probiotics and prebiotic |
| PlaceboPatients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics) | Other | Placebo |
Primary outcome
Complete bowel movements
Time frame: 4 weeks
Change in the mean number of complete spontaneous bowel movements
7 secondary outcomes
Number of bowel movements
Time frame: 4 weeks
Stool consistency
Time frame: 4 weeks
Laxative use
Time frame: 4 weeks
Treatment satisfaction
Time frame: 4 weeks
Treatment continuation
Time frame: 4 weeks
Increase in one or more complete bowel movements
Time frame: 4 weeks
Frequency of three or more complete bowel movements
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Derived from this study: PubMed 39470206Todd CL, Johnson EE, Stewart F, Wallace SA, Bryant A, Woodward S, Norton C. Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2024 Oct 29;10(10):CD002115. doi: 10.1002/14651858.CD002115.pub6.
- Derived from this study: PubMed 27543643Barichella M, Pacchetti C, Bolliri C, Cassani E, Iorio L, Pusani C, Pinelli G, Privitera G, Cesari I, Faierman SA, Caccialanza R, Pezzoli G, Cereda E. Probiotics and prebiotic fiber for constipation associated with Parkinson disease: An RCT. Neurology. 2016 Sep 20;87(12):1274-80. doi: 10.1212/WNL.0000000000003127. Epub 2016 Aug 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Pacchetti, MD principal investigator
IRCCS Istituto Neurologico Mondino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics and prebiotic in people with Constipation, run by Emanuele Cereda at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete bowel movements (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02459717, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.