Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04569656
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2020-09-24
Brief Title:
Treatment of Chronic Constipation in Parkinsons Disease
Sponsor:
IRCCS San Raffaele Roma
Organization:
IRCCS San Raffaele Roma
Study Overview
Official Title:
Pilot Study for the Evaluation of the Parameters of Activity of a Preparation of PHGG and Sodium Hyaluronate in Chronic Constipation in Patients With Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHGG-PD
Brief Summary:
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 59 pods containing seeds which produce the famous guar gum that is a natural polysaccharide
PHGG fiber is extracted from a herbaceous plant Cyamopsis Tetra-Gonolobus family Leguminosae of Indian origin it produces 59 pods containing seeds which produce the famous guar gum that is a natural polysaccharide
Detailed Description:
Parkinsons 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 dont 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
Constipation also adversely affects quality of life of PD patients beyond being an annoying symptom it may also cause other serious gastrointestinal pathologies ie magacolon intestinal pseudo-obstruction volvolus bowel perforation Moreover constipation can directly or indirectly influence the absorption of PD drugs with the result of a poor control on motor symptoms
Afterwards finding an effective treatment of constipation would be very important for quality of life of PD patients this treatment should be easy to be administered and should not have any interference with other PD drugs
PHGG fiber is extracted from a herbaceous plant Cyamopsis Tetra-Gonolobus family Leguminosae of Indian origin it produces 59 pods containing seeds which produce the famous guar gum that is a natural polysaccharide It differs from fibers derived from other plants for its high content of Galactomannan Guar gum referred to as GG is classified in the European list of additives under the symbol E 412 Recently a partially hydrolyzed guar gum indicated with the abbreviation PHGG has been developed Unlike the original and other fibers eg Psillium it has the characteristic to remain liquid and due to its low molecular weight to not turn into gel The introduction of molecules of water hydrolysis by an enzyme called Mannanase reduces the length and the molecular weight of guar gum and creates a fiber with unique properties by remaining liquid it does not cause bloating flatulence and meteorism that are adverse events typically associated to other fibers The association with sodium hyaluronate low molecular weight depolymerizes rapidly attracting water and amplifying the desired clinical effect
The aim of this pilot research study is to investigate the effectiveness of this formula Stick pack 30 ml containing PHGG 5 g and Hyaluronic 200 mg in PD patients affected by constipation
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 dont 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
Constipation also adversely affects quality of life of PD patients beyond being an annoying symptom it may also cause other serious gastrointestinal pathologies ie magacolon intestinal pseudo-obstruction volvolus bowel perforation Moreover constipation can directly or indirectly influence the absorption of PD drugs with the result of a poor control on motor symptoms
Afterwards finding an effective treatment of constipation would be very important for quality of life of PD patients this treatment should be easy to be administered and should not have any interference with other PD drugs
PHGG fiber is extracted from a herbaceous plant Cyamopsis Tetra-Gonolobus family Leguminosae of Indian origin it produces 59 pods containing seeds which produce the famous guar gum that is a natural polysaccharide It differs from fibers derived from other plants for its high content of Galactomannan Guar gum referred to as GG is classified in the European list of additives under the symbol E 412 Recently a partially hydrolyzed guar gum indicated with the abbreviation PHGG has been developed Unlike the original and other fibers eg Psillium it has the characteristic to remain liquid and due to its low molecular weight to not turn into gel The introduction of molecules of water hydrolysis by an enzyme called Mannanase reduces the length and the molecular weight of guar gum and creates a fiber with unique properties by remaining liquid it does not cause bloating flatulence and meteorism that are adverse events typically associated to other fibers The association with sodium hyaluronate low molecular weight depolymerizes rapidly attracting water and amplifying the desired clinical effect
The aim of this pilot research study is to investigate the effectiveness of this formula Stick pack 30 ml containing PHGG 5 g and Hyaluronic 200 mg in PD patients affected by constipation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None