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

Gastrointestinal Disorders in Parkinson's Disease Clinical Trial

— PHYTOPARK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719496
• Other study ID #: RC15_0396
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2016
• Last updated: April 20, 2018
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Gastrointestinal Disorders in Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• IBEROGAST

Locations

Country	Name	City	State
France	Tiphaine Rouaud	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	use of rectal laxatives	use of rectal laxatives (stool diary)	28 days
Secondary	clinical global improvement of gastrointestinal symptoms	Patient Global Impression of Change	28 days
Secondary	motor and non-motor symptoms	Movement Disorder Society - Unified Parkinson Disease Rating Scale	28 days
Secondary	Parkinson Disease Quotation ( PDQ39) (tolerability in parkinsonian)	Parkinson Disease Quotation ( PDQ39)	28 days
Secondary	Incidence of Treatment-Emergent Adverse Events (Tolerability)	adverse event reporting	28 days