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)

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: Completed
• Conditions: Gastrointestinal Disorders in Parkinson's Disease
• Intervention / Treatment: Drug: IBEROGAST

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: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Tiphaine Rouaud

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)	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

Outcome Measure	Measure Description	Time Frame
quality of evacuations	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)	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)	the impact of gastrointestinal symptoms on quality of life measured by the Short Form Health Survey (SF36)	28 days
use of rectal laxatives	use of rectal laxatives (stool diary)	28 days
clinical global improvement of gastrointestinal symptoms	Patient Global Impression of Change	28 days
motor and non-motor symptoms	Movement Disorder Society - Unified Parkinson Disease Rating Scale	28 days
Parkinson Disease Quotation ( PDQ39) (tolerability in parkinsonian)	Parkinson Disease Quotation ( PDQ39)	28 days
Incidence of Treatment-Emergent Adverse Events (Tolerability)	adverse event reporting	28 days

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: RC15_0396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No