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

NCT ID: NCT05126654

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COPD Microbial Colonization Respiratory Tract Disease

Keywords

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COPD Gut microbiota Respiratory tract prebiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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COPD with PHGG

COPD patient PHGG 5g/day for 1 month

Group Type EXPERIMENTAL

Partially Hydrolyzed Guar Gum (PHGG)

Intervention Type DIETARY_SUPPLEMENT

Partially Hydrolyzed Guar Gum 5 gram/day for 1 month

COPD without PHGG

COPD patient without PHGG 5g/day for 1 month

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy with PHGG

Healthy PHGG 5g/day for 1 month

Group Type ACTIVE_COMPARATOR

Partially Hydrolyzed Guar Gum (PHGG)

Intervention Type DIETARY_SUPPLEMENT

Partially Hydrolyzed Guar Gum 5 gram/day for 1 month

Healthy without PHGG

Healthy without PHGG 5g/day for 1 month

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Partially Hydrolyzed Guar Gum (PHGG)

Partially Hydrolyzed Guar Gum 5 gram/day for 1 month

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fu Jen Catholic University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chia-Chen Lu, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Respiratory Therapy, College of Medicine, Fu-Jen Catholic University, Taiwan

Locations

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Yen-Liang Kuo

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yen-Liang Kuo, MD

Role: CONTACT

Phone: 886-2-85128888

Email: [email protected]

Facility Contacts

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Yen-Liang Kuo, MD

Role: primary

Other Identifiers

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FJUH110120

Identifier Type: -

Identifier Source: org_study_id