Parkinson DiseasePhase 2PHGG-PDNCT04569656
Treatment of Chronic Constipation in Parkinson's Disease
A Phase 2 study testing hydrolyzed guar gum in people with Parkinson Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial 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 5/9 pods containing seeds which produce the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- hydrolyzed guar gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2016to 20 Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 Parkinson's Disease
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.
Read the detailed description
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.
Constipation also adversely affects quality of life of PD patients: beyond being an annoying symptom, it may also cause other serious gastrointestinal pathologies (i.e. 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 5/9 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.
- Conditions
- Parkinson Disease
- Being tested
- hydrolyzed guar gum
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrolyzed guar gumDrug
Also called PHGG
treatment with Stick pack 30 ml containing PHGG 5 gr e Hyaluronic Acid 200 mg for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | 6 week treatment with Stick pack 30 ml containing PHGG 5 gr e Hyaluronic Acid 200 mg Receives: Drug: hydrolyzed guar gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
to investigate the effectiveness of the preparation of PHGG and sodium hyaluronate on symptoms of PD patients with chronic constipation
using the scale the Patient Assessment of Constipation-Symptoms PAC-SYM The 12-item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.
Measured: trough study completation, an average of 6 weeks
to investigate the effectiveness of the preparation of PHGG and sodium hyaluronate on symptoms of PD patients with chronic constipation
Bristol Stool Chart
Measured: trough study completation, an average of 6 weeks
to investigate the effectiveness of the preparation of PHGG and sodium hyaluronate on quality of life of PD patients with chronic constipation
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.
Measured: trough study completation, an average of 6 weeks
Secondary outcomes (3)
To investigate compliance to treatment.
assessment of compliance by Clinical Global Impression (CGI) for patient, study drug accountability and a questionnaire for compliance.
comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale
Measured: through study completion, an average of 6 weeks
To investigate acceptance to treatment.
assessment of acceptance by Clinical Global Impression (CGI) for patient, study drug accountability.
comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale
Measured: through study completion, an average of 6 weeks
To investigate adherence to treatment.
assessment of adherence to treatment by Clinical Global Impression (CGI) for patient, study drug accountability.
comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale
Measured: through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start2 Feb 2016
- Primary completion20 Dec 2016
- Study completion20 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fabrizio stocchi, md phd, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569656
- Sponsor's protocol ID
- RP 04/15
- Acronym
- PHGG-PD
- Status last verified
- Oct 2022
- First submitted
- 24 Sep 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after the end of study
Publications
Vacca L, Proietti S, Bravi D, Radicati FG, Stocchi F. Effectiveness of an herbaceous derivatives, PHGG, plus sodium hyaluronate in the treatment of chronic constipation in patients with Parkinson's disease: a pilot study. Neurol Sci. 2022 Feb;43(2):1055-1059. doi: 10.1007/s10072-021-05342-8. Epub 2021 Jun 4.
PubMed 34086122
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04569656
- Acronym / sponsor ID
- PHGG-PD / RP 04/15
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Constipation also adversely affects quality of life of PD patients: beyond being an annoying symptom, it may also cause other serious gastrointestinal pathologies (i.e. 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 5/9 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: hydrolyzed guar gum6 week treatment with Stick pack 30 ml containing PHGG 5 gr e Hyaluronic Acid 200 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrolyzed guar gumAlso: PHGGtreatment with Stick pack 30 ml containing PHGG 5 gr e Hyaluronic Acid 200 mg for 6 weeks | Drug | treatment |
Primary outcome
to investigate the effectiveness of the preparation of PHGG and sodium hyaluronate on symptoms of PD patients with chronic constipation
Time frame: trough study completation, an average of 6 weeks
using the scale the Patient Assessment of Constipation-Symptoms PAC-SYM The 12-item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.
to investigate the effectiveness of the preparation of PHGG and sodium hyaluronate on symptoms of PD patients with chronic constipation
Time frame: 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
Time frame: 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.
3 secondary outcomes
To investigate compliance to treatment.
Time frame: through study completion, an average of 6 weeks
To investigate acceptance to treatment.
Time frame: through study completion, an average of 6 weeks
To investigate adherence to treatment.
Time frame: through study completion, an average of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 34086122Vacca L, Proietti S, Bravi D, Radicati FG, Stocchi F. Effectiveness of an herbaceous derivatives, PHGG, plus sodium hyaluronate in the treatment of chronic constipation in patients with Parkinson's disease: a pilot study. Neurol Sci. 2022 Feb;43(2):1055-1059. doi: 10.1007/s10072-021-05342-8. Epub 2021 Jun 4.
- Individual participant dataSharing planned: Yes. after the end of study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fabrizio stocchi, md phd principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hydrolyzed guar gum in people with Parkinson Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to investigate the effectiveness of the preparation of PHGG and sodium hyaluronate on symptoms of PD patients with chronic constipation (time frame: trough study completation, an average of 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04569656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.