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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

PAOLA IOVINO, MD contact

+39 3357822672

piovino@unisa.it

Italy1 site, 1 recruiting

  • Aou Sangiovanni E Ruggi D'Aragona

    Salerno, 84000

    Recruiting

Other trials in Italy

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).

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 groups in NCT04293159
Study groupRoleWhat they receive
Lactobacillus casei DG (Enterolactis duo®)ExperimentalLactobacillus 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.

  1. 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

  2. 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

  3. 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)

  1. 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

  2. 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.

  1. First posted3 Mar 2020
  2. Study start14 May 2019
  3. Primary completionDec 2022 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

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)
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 22993448

  • Fasano 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 25987282

  • Martinez-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 28467916

  • Bellini 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 28088179

  • Neri 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 26867677

  • Cappello 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

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; AzTrials last refreshed its copy on 7 Nov 2026.

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