Partially Hydrolyzed Guar Gum (PHGG) for Amelioration of Chronic Obstructive Pulmonary Disease (COPD)

November 18, 2021 updated by: Fu Jen Catholic University Hospital

Development of a Partially Hydrolyzed Guar Gum (PHGG) Based Synbiotic for Amelioration of Chronic Obstructive Pulmonary Disease (COPD)

Some components of the diet could promote the growth of certain bacterial strains present in the intestine, which are closely associated with benefits for host health. An intestinal commensal Parabacteroides goldsteinii (Pg) was highlighted to be significantly negatively associated with severity of COPD. Furthermore, the investigators identify the potential prebiotics (PHGG) which may enrich the abundance of P. goldsteinii and increase the probiotic effect of P. goldsteinii.

The investigators designed a randomized control study, which enroll adults diagnosed with COPD. Then the two groups will receive PHGG or not. Stool samples will be collected. The ameliorative efficacy will be evaluated by questionnaire and lung function test. Intestinal microbiota and metabolome will be analyzed and the correlation with lung function indices will be further investigated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is well known that some components of the diet could promote the growth of certain bacterial strains present in the intestine, which are closely associated with benefits for host health. In the previous study, the investigators found that an intestinal commensal Parabacteroides goldsteinii (Pg) was highlighted to be significantly negatively associated with severity of COPD. Furthermore, the investigators identify the potential prebiotics (PHGG) which may enrich the abundance of P. goldsteinii and increase the probiotic effect of P. goldsteinii. However, the effect of PHGG supplement on compositional and functional properties of the human microbiota with COPD still remains unclear.

In this proposal, the investigators designed a randomized control study, which enroll adults diagnosed with COPD. The investigators will review their past medical records and related image and lung function test. Then the two groups will receive PHGG or not. Stool samples will be collected. The ameliorative efficacy will be evaluated by questionnaire and lung function test. Intestinal microbiota and metabolome will be analyzed and the correlation with lung function indices will be further investigated. In the future, it may be used to investigate and analyze the change of microbiota and metabolome, then develop possible treatment options of COPD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age of 40-85 years
  • diagnosis of COPD made by pulmonologist
  • provision of written informed consent

Exclusion Criteria:

  • severe and unstable comorbidities or active malignancy
  • COPD exacerbation within the 4 weeks prior
  • cognitive impairment or a psychiatric disorder
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: COPD with PHGG
COPD patient PHGG 5g/day for 1 month
Dietary supplement: Partially Hydrolyzed Guar Gum (PHGG)
Partially Hydrolyzed Guar Gum 5 gram/day for 1 month
No Intervention: COPD without PHGG
COPD patient without PHGG 5g/day for 1 month
Active Comparator: Healthy with PHGG
Healthy PHGG 5g/day for 1 month
Dietary supplement: Partially Hydrolyzed Guar Gum (PHGG)
Partially Hydrolyzed Guar Gum 5 gram/day for 1 month
No Intervention: Healthy without PHGG
Healthy without PHGG 5g/day for 1 month

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Modified Medical Research Council Dyspnea Scale (mMRC)
Time Frame: after PHGG 5 gram/day for 1 month
change of mMRC scale, 0 the best, 4 the worst
after PHGG 5 gram/day for 1 month
COPD Assessment Test (CAT)
Time Frame: after PHGG 5 gram/day for 1 month
change of CAT (0 the best, 40 the worst)
after PHGG 5 gram/day for 1 month
St. George's Respiratory Questionnaire (SGRQ)
Time Frame: after PHGG 5 gram/day for 1 month
change of SGRQ score, 0 the best, 100 the worst
after PHGG 5 gram/day for 1 month
FEV1
Time Frame: after PHGG 5 gram/day for 1 month
change of FEV1
after PHGG 5 gram/day for 1 month
FEV1%
Time Frame: after PHGG 5 gram/day for 1 month
change of FEV1%
after PHGG 5 gram/day for 1 month
FVC
Time Frame: after PHGG 5 gram/day for 1 month
change of FVC
after PHGG 5 gram/day for 1 month
FVC%
Time Frame: after PHGG 5 gram/day for 1 month
change of FVC%
after PHGG 5 gram/day for 1 month
FEV1/FVC%
Time Frame: after PHGG 5 gram/day for 1 month
change of FEV1/FVC%
after PHGG 5 gram/day for 1 month
FEV3
Time Frame: after PHGG 5 gram/day for 1 month
change of FEV3
after PHGG 5 gram/day for 1 month
FEV3%
Time Frame: after PHGG 5 gram/day for 1 month
change of FEV3%
after PHGG 5 gram/day for 1 month
FEV3/FVC%
Time Frame: after PHGG 5 gram/day for 1 month
change of FEV3/FVC%
after PHGG 5 gram/day for 1 month
MMEF
Time Frame: after PHGG 5 gram/day for 1 month
change of MMEF
after PHGG 5 gram/day for 1 month
MMEF%
Time Frame: after PHGG 5 gram/day for 1 month
change of MMEF%
after PHGG 5 gram/day for 1 month
PEF
Time Frame: after PHGG 5 gram/day for 1 month
change of PEF
after PHGG 5 gram/day for 1 month
PEF%
Time Frame: after PHGG 5 gram/day for 1 month
change of PEF%
after PHGG 5 gram/day for 1 month
blood cytokine
Time Frame: after PHGG 5 gram/day for 1 month
change of blood cytokine
after PHGG 5 gram/day for 1 month
Microbiota of stool
Time Frame: after PHGG 5 gram/day for 1 month
change of stool microbiota contribution
after PHGG 5 gram/day for 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fu Jen Catholic University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chia-Chen Lu, PhD, Department of Respiratory Therapy, College of Medicine, Fu-Jen Catholic University, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FJUH110120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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