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
- Gastrointestinal Disorders in Parkinson's Disease
- Interventions
- Drug: IBEROGAST
- Registration Number
- NCT02719496
- Lead Sponsor
- Nantes University Hospital
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IBEROGAST IBEROGAST Dose of 20 drops three times a day for 28 days, on constipation parkinsonian patients with disorders intestinal transit.
- Primary Outcome Measures
Name Time Method increasing the weekly number of exemptions of 3 in the last week of treatment compared with the reference week (Efficacity) 28 days evaluate the efficacy of Iberogast, over a 28-day period, for the treatment of constipation in parkinsonian patients suffering from gastrointestinal disorders.
- Secondary Outcome Measures
Name Time Method quality of evacuations 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).
use of rectal laxatives 28 days use of rectal laxatives (stool diary)
Gastrointestinal Symptom Rating Scale (quality of life) 28 days the impact of gastrointestinal symptoms on quality of life measured by the Gastrointestinal Symptom Rating Scale
Short Form Health Survey (SF36) (quality of life) 28 days the impact of gastrointestinal symptoms on quality of life measured by the Short Form Health Survey (SF36)
Parkinson Disease Quotation ( PDQ39) (tolerability in parkinsonian) 28 days Parkinson Disease Quotation ( PDQ39)
Incidence of Treatment-Emergent Adverse Events (Tolerability) 28 days adverse event reporting
clinical global improvement of gastrointestinal symptoms 28 days Patient Global Impression of Change
motor and non-motor symptoms 28 days Movement Disorder Society - Unified Parkinson Disease Rating Scale
Trial Locations
- Locations (1)
Tiphaine Rouaud
🇫🇷Nantes, France