Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's Disease (PHYTOPARK)

April 20, 2018 updated by: Nantes University Hospital
The main objective of this study is to evaluate the efficacy of STW5 Iberogast, over a 28-day period, for the treatment of constipation in parkinsonian patients suffering from gastrointestinal disorders.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Gastrointestinal disorders are the most common non-motor symptoms of Parkinson's disease (PD). They affect the entire intestinal tract and include excess saliva stasis (70% of patients), dysphagia (52%), gastroparesis (34-45%), and constipation. Gastroparesis participates in dyspepsia and abdominal pain. Constipation, as defined by the international standards criteria of Rome III, is present in 59% of PD patients and leads to functional impairment in 70% of patients. The mechanism underlying constipation is multifactorial and may include slow transit and defecation disorders secondary to anorectal dysfunction. Bowel disorders are present in the early stage of the disease and usually precede the onset of motor symptoms. They may result from lesions of the enteric nervous system, of the autonomic nervous system, and from probable alterations in gastrointestinal motility controlled by the central nervous system. The STW5 (Iberogast, Steigerwald, Germany) is a herbal agent composed of nine plant extracts, with prokinetic, antispasmodic, prosecretory, anti-inflammatory and anti-oxidant properties. These properties have been demonstrated in animals and in human pathology, in the treatment of dyspepsia and irritable bowel syndrome. It is the only phytotherapeutic agent which efficacy was demonstrated by randomized double-blind trials in these indications. In PD, the STW5 could improve constipation due to its prokinetic effects of the prosecretory enteric neurons. It could also improve dyspepsia and abdominal pain by its antispasmodic properties. We propose to study the efficacy and the safety of STW5 on bowel dysfunction in parkinsonian patients, especially on constipation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • Tiphaine Rouaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient 30 to 80 years
  • Parkinson's disease according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank
  • Presence of constipation defined by the Rome III criteria Functional constipation
  • Social assured Patient
  • Patients with signed consent

Exclusion Criteria:

  • Organic Affection colic
  • Constipation Drug
  • Other neurological disorder Parkinson's disease
  • Metabolic disease diabetes collagenoses
  • Severe renal or hepatic impairment
  • Pregnant or lactating women
  • Premenopausal women without contraceptive device effective
  • Regular and prolonged use of history (> 12 months) of laxatives irritants
  • Use of oral laxative treatment in the two weeks before the start of treatment, and refusal to stop these treatment during the course of the study
  • Taking treatment antabuse
  • Cognitive impairment compromising understanding or application instructions
  • Patient already included in a research protocol
  • Minors
  • Nobody protected by law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IBEROGAST
Dose of 20 drops three times a day for 28 days, on constipation parkinsonian patients with disorders intestinal transit.
Drug: IBEROGAST

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
increasing the weekly number of exemptions of 3 in the last week of treatment compared with the reference week (Efficacity)
Time Frame: 28 days
evaluate the efficacy of Iberogast, over a 28-day period, for the treatment of constipation in parkinsonian patients suffering from gastrointestinal disorders.
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
quality of evacuations
Time Frame: 28 days
weekly percentage defecation requiring thrusts, or accompanied by a sensation of incomplete rectal evacuation (agenda stool), shape and consistency of stools (Bristol scale).
28 days
Gastrointestinal Symptom Rating Scale (quality of life)
Time Frame: 28 days
the impact of gastrointestinal symptoms on quality of life measured by the Gastrointestinal Symptom Rating Scale
28 days
Short Form Health Survey (SF36) (quality of life)
Time Frame: 28 days
the impact of gastrointestinal symptoms on quality of life measured by the Short Form Health Survey (SF36)
28 days
use of rectal laxatives
Time Frame: 28 days
use of rectal laxatives (stool diary)
28 days
clinical global improvement of gastrointestinal symptoms
Time Frame: 28 days
Patient Global Impression of Change
28 days
motor and non-motor symptoms
Time Frame: 28 days
Movement Disorder Society - Unified Parkinson Disease Rating Scale
28 days
Parkinson Disease Quotation ( PDQ39) (tolerability in parkinsonian)
Time Frame: 28 days
Parkinson Disease Quotation ( PDQ39)
28 days
Incidence of Treatment-Emergent Adverse Events (Tolerability)
Time Frame: 28 days
adverse event reporting
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC15_0396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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