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临床试验/NCT04569656
NCT04569656已完成2 期

Pilot Study for the Evaluation of the Parameters of Activity of a Preparation of PHGG and Sodium Hyaluronate in Chronic Constipation in Patients With Parkinson's Disease

IRCCS San Raffaele Roma1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2016年2月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
to investigate the effectiveness of the preparation of PHGG and sodium hyaluronate on symptoms of PD patients with chronic constipation

研究概览

简要总结

Chronic constipation is the most common gastrointestinal symptom reported by PD patients; it could be one of the manifestations of disease onset.

PHGG fiber is extracted from a herbaceous plant (Cyamopsis Tetra-Gonolobus, family: Leguminosae) of Indian origin: it produces 5/9 pods containing seeds which produce the famous guar gum, that is a natural polysaccharide.

详细描述

Parkinson's disease (PD) is a chronic and progressive neurodegenerative disorder characterized by motor symptoms. In recent years it has become clear that motor symptoms are associated with non-motor and non-dopaminergic symptoms throughout the natural progression of the disease, and sometimes even before the onset of motor manifestations.

Chronic constipation is the most common gastrointestinal symptom reported by PD patients; it could be one of the manifestations of disease onset.

In the past, constipation was considered a side effect of neurological therapy, but more recent studies have evidenced that it is widely present in patients with early untreated PD too and it may precede of years the onset of motor symptoms.

The prevalence of constipation can reach 80% of patients with PD, with an incidence of decreased stool frequency (less than 3 bowel movements per week) of 57-67% of patients.

Although constipation should be interpreted as part of the disease, patients often don't link it to PD, with the result that it may be neglected or poorly managed. Moreover, continuous and incongruous use of laxatives, that are often used in increasing doses in order to maintain efficacy, may cause the onset of abdominal pain and diarrhoea with the risk of bowel incontinence and other side effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic PD according to UK PDS Brain Bank Clinical Diagnostic Criteria.
  • Chronic constipation according to Roma III criteria for chronic functional constipation lasting from at least 6 months.
  • Absence of dementia.
  • Patients who are able to understand and sign the informed consent for participation in the study

排除标准

  • People who suffer from other comorbidities that could interfere with the results of the study according to the investigator.
  • People who are not able to provide reliable answers to the questionnaire according to the opinion of the investigator.
  • Inclusion in other clinical trials at the time of the visit.

研究组 & 干预措施

treatment

Experimental

6 week treatment with Stick pack 30 ml containing PHGG 5 gr e Hyaluronic Acid 200 mg

干预措施: hydrolyzed guar gum (Drug)

结局指标

主要结局

to investigate the effectiveness of the preparation of PHGG and sodium hyaluronate on symptoms of PD patients with chronic constipation

时间窗: trough study completation, an average of 6 weeks

Bristol Stool Chart

to investigate the effectiveness of the preparation of PHGG and sodium hyaluronate on quality of life of PD patients with chronic constipation

时间窗: trough study completation, an average of 6 weeks

using Patient Assessment of Constipation Quality of Life PAC-QOL subcategorized to 4 items on physical discomfort, 8 items on psychosocial discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. Response choice is a Likert scale from 0 to 4. Higher scores mean higher negative effects on quality of life. Items 25, 26, 27, and 28 should be scored reversed because they are positive questions.

次要结局

  • To investigate compliance to treatment.(through study completion, an average of 6 weeks)
  • To investigate acceptance to treatment.(through study completion, an average of 6 weeks)
  • To investigate adherence to treatment.(through study completion, an average of 6 weeks)

研究者

发起方
IRCCS San Raffaele Roma
申办方类型
Other
责任方
Sponsor

研究点 (1)

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