NCT05126654UnknownNot Applicable

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

Fu Jen Catholic University Hospital1 site in 1 country60 target enrollmentStarted: November 1, 2021Last updated: November 19, 2021

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Sponsor: Fu Jen Catholic University Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: FEV1/FVC%

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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

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 Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 40 Years to 85 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

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

Arms & Interventions

COPD with PHGG

Experimental

COPD patient PHGG 5g/day for 1 month

Intervention: Partially Hydrolyzed Guar Gum (PHGG) (Dietary Supplement)

COPD without PHGG

No Intervention

COPD patient without PHGG 5g/day for 1 month

Healthy with PHGG

Active Comparator

Healthy PHGG 5g/day for 1 month

Intervention: Partially Hydrolyzed Guar Gum (PHGG) (Dietary Supplement)

Healthy without PHGG

No Intervention

Healthy without PHGG 5g/day for 1 month