Treatment of Chronic Constipation in Parkinson's Disease

NCT04569656 | Completed Phase 2 DMC

• 1 other identifier: RP 04/15
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 5/9 pods containing seeds which produce the famous guar gum, that is a natural polysaccharide.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  trough study completation, an average of 6 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

treatment

EXPERIMENTAL

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

Drug: hydrolyzed guar gum

Interventions

hydrolyzed guar gum DRUG

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

Also known as: PHGG

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele

Roma, 00163, Italy

Location

Related Publications (1)

• 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.

  PMID: 34086122 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• fabrizio stocchi, md phd

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 30, 2020
• Study Start: February 2, 2016
• Primary Completion: December 20, 2016
• Study Completion: December 20, 2016
• Last Updated: April 10, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the study
• Access Criteria: request by email

Locations

IT (1)