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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Gastrointestinal Disorders in Parkinson's Disease

Intervention / Treatment
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* Drug: IBEROGAST


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBEROGAST<br>Dose of 20 drops three times a day for 28 days, on constipation parkinsonian patients with disorders intestinal transit. | Drug: IBEROGAST<br> <br> |

What is the study measuring?
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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 |