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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

Phase 2
Completed
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
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
IBEROGASTIBEROGASTDose of 20 drops three times a day for 28 days, on constipation parkinsonian patients with disorders intestinal transit.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
quality of evacuations28 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 laxatives28 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 symptoms28 days

Patient Global Impression of Change

motor and non-motor symptoms28 days

Movement Disorder Society - Unified Parkinson Disease Rating Scale

Trial Locations

Locations (1)

Tiphaine Rouaud

🇫🇷

Nantes, France

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