Parkinson DiseaseNCT04293159
Effect of Probiotic on Constipation in Patients With Parkinson's Disease
A study testing Lactobacillus casei DG (Enterolactis duo®) in people with Parkinson Disease and Constipation, run by University of Salerno at 1 site in Italy.
Trial summary
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis ®duo) effect on constipation and on neuropsychological performance Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease, Constipation
- What is being tested?
- Lactobacillus casei DG (Enterolactis duo®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 14 May 2019to Jun 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A positive diagnosis of functional constipation or Irritable Bowel Syndrome -subtype constipation according to Rome IV criteria.
- Negative for colon cancer screening
- Negative relevant additional screening or consultation whenever appropriate.
- Ability of conforming to the study protocol.
- Stable treatment for Parkinson's disease
Who cannot join
- Presence of any other relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values a part from Parkinson's disease
- Ascertained intestinal organic diseases, including ascertained celiac disease or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- Previous major abdominal surgeries.
- Inability to conform with protocol.
- Recent history or suspicion of alcohol abuse or drug addiction.
- Previous participation in this study.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Aou Sangiovanni E Ruggi D'Aragona
Salerno, 84000
About this study
Official title: Effect of Probiotic on Constipation and on Neuropsychological Performance in Patients With Parkinson's Disease
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis ®duo) effect on constipation and on neuropsychological performance
Read the detailed description
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis® duo) effect on overall abdominal pain, bowel movements and other abdominal symptoms and on neuropsychological performance in patients with Parkinson's Disease. The investigators suppose that, due to the immunomodulatory action of probiotics, overall neuropsychological function will improve as well as due also to prebiotic abdominal symptoms will decrease following consumption of Lactobacillus casei DG (Enterolactis® duo).
- Conditions
- Parkinson Disease, Constipation
- Being tested
- Lactobacillus casei DG (Enterolactis duo®)
- Keywords
- constipation, Parkinson's disease
- Medical subject headings
- Parkinson Disease, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus casei DG (Enterolactis duo®)Dietary supplement
Lactobacillus casei DG (Enterolactis duo®)
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus casei DG (Enterolactis duo®) | Experimental | Lactobacillus casei DG (Enterolactis duo®) Receives: Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfaction with therapy
A "satisfaction with therapy" score (on a 7-point Likert scale: 1 = extremely dissatisfied, 2 = very dissatisfied, 3 = dissatisfied, 4 = partially satisfied, 5 = satisfied, 6 = very satisfied, 7 = extremely satisfied)
Measured: 12 weeks
Improvement after treatment
"Improvement after treatment" was evaluated with a global rating-of-change scale (-7 to +7: -7 = extremely worsened, 0 = unchanged,
+7 = extremely improved). "Improvement after treatment" was defined by an increase in the global rating-of-change scale of ≥2 points.
Measured: 12 WEEKS
neuropsychological function
The Non-Motor Symptoms Scale (NMSS) is a 30-item rater-based scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients at all stages of PD.The total NMSS score ranges from 0 to 360, the worst.
Measured: 12 weeks
Secondary outcomes (2)
the Unified Parkinson Disease Rating Scale (UPDRS, italian version)
the Unified Parkinson Disease Rating Scale (UPDRS, italian version). The UPDRS is a rating tool used to gauge the course of Parkinson's disease in patients. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability); The Non-motor-symptoms scale (NMSS, italian version)
Measured: 12 WEEKS
M-PAC SYM
M-PAC-SYM)5 The Patient Assessment of Constipation Symptoms (scoring from 0 = absent to 4 = very strong)
Measured: 12 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start14 May 2019
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salerno
- Sponsor type
- University, hospital or other
- Collaborators
- Roberto Erro, Maria Teresa Pellecchia, Antonella Santonicola, Carolina Ciacci
- Responsible party
- Principal investigator, PAOLA IOVINO, University of Salerno
- Investigators
- PAOLA IOVINO, MD, Principal investigator, University of Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293159
- Sponsor's protocol ID
- University of Salerno
- Status last verified
- May 2022
- First submitted
- 19 Feb 2020
- Last updated
- 20 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Erro R, Picillo M, Vitale C, Amboni M, Moccia M, Longo K, Cozzolino A, Giordano F, De Rosa A, De Michele G, Pellecchia MT, Barone P. Non-motor symptoms in early Parkinson's disease: a 2-year follow-up study on previously untreated patients. J Neurol Neurosurg Psychiatry. 2013 Jan;84(1):14-7. doi: 10.1136/jnnp-2012-303419. Epub 2012 Sep 19.
PubMed 22993448Fasano A, Visanji NP, Liu LW, Lang AE, Pfeiffer RF. Gastrointestinal dysfunction in Parkinson's disease. Lancet Neurol. 2015 Jun;14(6):625-39. doi: 10.1016/S1474-4422(15)00007-1.
PubMed 25987282Martinez-Martinez MI, Calabuig-Tolsa R, Cauli O. The effect of probiotics as a treatment for constipation in elderly people: A systematic review. Arch Gerontol Geriatr. 2017 Jul;71:142-149. doi: 10.1016/j.archger.2017.04.004. Epub 2017 Apr 14.
PubMed 28467916Bellini M, Usai-Satta P, Bove A, Bocchini R, Galeazzi F, Battaglia E, Alduini P, Buscarini E, Bassotti G; ChroCoDiTE Study Group, AIGO. Chronic constipation diagnosis and treatment evaluation: the "CHRO.CO.DI.T.E." study. BMC Gastroenterol. 2017 Jan 14;17(1):11. doi: 10.1186/s12876-016-0556-7.
PubMed 28088179Neri L, Iovino P; Laxative Inadequate Relief Survey (LIRS) Group. Bloating is associated with worse quality of life, treatment satisfaction, and treatment responsiveness among patients with constipation-predominant irritable bowel syndrome and functional constipation. Neurogastroenterol Motil. 2016 Apr;28(4):581-91. doi: 10.1111/nmo.12758. Epub 2016 Feb 12.
PubMed 26867677Cappello C, Tremolaterra F, Pascariello A, Ciacci C, Iovino P. A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life. Int J Colorectal Dis. 2013 Mar;28(3):349-58. doi: 10.1007/s00384-012-1552-1. Epub 2012 Aug 12.
PubMed 22885882
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic on Constipation and on Neuropsychological Performance in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04293159
- Acronym / sponsor ID
- University of Salerno
- Conditions
- Parkinson Disease, Constipation
- Keywords
- constipation, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of SalernoUniversity, hospital or other
- Collaborators
- Roberto Erro, Maria Teresa Pellecchia, Antonella Santonicola, Carolina Ciacci
- Study start
- 14 May 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 3 Mar 2020 (actual)
- 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.
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis ®duo) effect on constipation and on neuropsychological performance
Detailed description
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis® duo) effect on overall abdominal pain, bowel movements and other abdominal symptoms and on neuropsychological performance in patients with Parkinson's Disease. The investigators suppose that, due to the immunomodulatory action of probiotics, overall neuropsychological function will improve as well as due also to prebiotic abdominal symptoms will decrease following consumption of Lactobacillus casei DG (Enterolactis® duo).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus casei DG (Enterolactis duo®) | Experimental | Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®)Lactobacillus casei DG (Enterolactis duo®) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A positive diagnosis of functional constipation or Irritable Bowel Syndrome -subtype constipation according to Rome IV criteria.
- Negative for colon cancer screening
- Negative relevant additional screening or consultation whenever appropriate.
- Ability of conforming to the study protocol.
- Stable treatment for Parkinson's disease
Key exclusion criteria (6 listed)
- Presence of any other relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values a part from Parkinson's disease
- Ascertained intestinal organic diseases, including ascertained celiac disease or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- Previous major abdominal surgeries.
- Inability to conform with protocol.
- Recent history or suspicion of alcohol abuse or drug addiction.
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 |
|---|---|---|
| Lactobacillus casei DG (Enterolactis duo®)Lactobacillus casei DG (Enterolactis duo®) | Dietary supplement | Lactobacillus casei DG (Enterolactis duo®) |
Primary outcome
satisfaction with therapy
Time frame: 12 weeks
A "satisfaction with therapy" score (on a 7-point Likert scale: 1 = extremely dissatisfied, 2 = very dissatisfied, 3 = dissatisfied, 4 = partially satisfied, 5 = satisfied, 6 = very satisfied, 7 = extremely satisfied)
Improvement after treatment
Time frame: 12 WEEKS
"Improvement after treatment" was evaluated with a global rating-of-change scale (-7 to +7: -7 = extremely worsened, 0 = unchanged, +7 = extremely improved). "Improvement after treatment" was defined by an increase in the global rating-of-change scale of ≥2 points.
neuropsychological function
Time frame: 12 weeks
The Non-Motor Symptoms Scale (NMSS) is a 30-item rater-based scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients at all stages of PD.The total NMSS score ranges from 0 to 360, the worst.
2 secondary outcomes
the Unified Parkinson Disease Rating Scale (UPDRS, italian version)
Time frame: 12 WEEKS
M-PAC SYM
Time frame: 12 WEEKS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Results publication: PubMed 22993448Erro R, Picillo M, Vitale C, Amboni M, Moccia M, Longo K, Cozzolino A, Giordano F, De Rosa A, De Michele G, Pellecchia MT, Barone P. Non-motor symptoms in early Parkinson's disease: a 2-year follow-up study on previously untreated patients. J Neurol Neurosurg Psychiatry. 2013 Jan;84(1):14-7. doi: 10.1136/jnnp-2012-303419. Epub 2012 Sep 19.
- Results publication: PubMed 25987282Fasano A, Visanji NP, Liu LW, Lang AE, Pfeiffer RF. Gastrointestinal dysfunction in Parkinson's disease. Lancet Neurol. 2015 Jun;14(6):625-39. doi: 10.1016/S1474-4422(15)00007-1.
- Results publication: PubMed 28467916Martinez-Martinez MI, Calabuig-Tolsa R, Cauli O. The effect of probiotics as a treatment for constipation in elderly people: A systematic review. Arch Gerontol Geriatr. 2017 Jul;71:142-149. doi: 10.1016/j.archger.2017.04.004. Epub 2017 Apr 14.
- Results publication: PubMed 28088179Bellini M, Usai-Satta P, Bove A, Bocchini R, Galeazzi F, Battaglia E, Alduini P, Buscarini E, Bassotti G; ChroCoDiTE Study Group, AIGO. Chronic constipation diagnosis and treatment evaluation: the "CHRO.CO.DI.T.E." study. BMC Gastroenterol. 2017 Jan 14;17(1):11. doi: 10.1186/s12876-016-0556-7.
- Results publication: PubMed 26867677Neri L, Iovino P; Laxative Inadequate Relief Survey (LIRS) Group. Bloating is associated with worse quality of life, treatment satisfaction, and treatment responsiveness among patients with constipation-predominant irritable bowel syndrome and functional constipation. Neurogastroenterol Motil. 2016 Apr;28(4):581-91. doi: 10.1111/nmo.12758. Epub 2016 Feb 12.
- Results publication: PubMed 22885882Cappello C, Tremolaterra F, Pascariello A, Ciacci C, Iovino P. A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life. Int J Colorectal Dis. 2013 Mar;28(3):349-58. doi: 10.1007/s00384-012-1552-1. Epub 2012 Aug 12.
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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.
PAOLA IOVINO, MD principal investigator
University of Salerno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus casei DG (Enterolactis duo®) in people with Parkinson Disease and Constipation, run by University of Salerno 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 May 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PAOLA IOVINO, MD (+39 3357822672, piovino@unisa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
satisfaction with therapy (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT04293159, which also lists 6 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 20 May 2022.