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

Primary Purpose

COPD, Microbial Colonization, Respiratory Tract Disease

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Partially Hydrolyzed Guar Gum (PHGG)

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Gut microbiota, Respiratory tract, prebiotics

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Yen-Liang KuoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Active Comparator

No Intervention

Arm Label

COPD with PHGG

COPD without PHGG

Healthy with PHGG

Healthy without PHGG

Arm Description

COPD patient PHGG 5g/day for 1 month

COPD patient without PHGG 5g/day for 1 month

Healthy PHGG 5g/day for 1 month

Healthy without PHGG 5g/day for 1 month

Outcomes

Primary Outcome Measures

Modified Medical Research Council Dyspnea Scale (mMRC)

change of mMRC scale, 0 the best, 4 the worst

COPD Assessment Test (CAT)

change of CAT (0 the best, 40 the worst)

St. George's Respiratory Questionnaire (SGRQ)

change of SGRQ score, 0 the best, 100 the worst

FEV1

change of FEV1

FEV1%

change of FEV1%

FVC

change of FVC

FVC%

change of FVC%

FEV1/FVC%

change of FEV1/FVC%

FEV3

change of FEV3

FEV3%

change of FEV3%

FEV3/FVC%

change of FEV3/FVC%

MMEF

change of MMEF

MMEF%

change of MMEF%

PEF

change of PEF

PEF%

change of PEF%

blood cytokine

change of blood cytokine

Microbiota of stool

change of stool microbiota contribution

Secondary Outcome Measures

Full Information

NCT ID

NCT05126654

First Posted

October 12, 2021

Last Updated

November 18, 2021

Sponsor

Fu Jen Catholic University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05126654

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fu Jen Catholic University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Microbial Colonization, Respiratory Tract Disease

Keywords

COPD, Gut microbiota, Respiratory tract, prebiotics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COPD with PHGG

Arm Type

Experimental

Arm Description

COPD patient PHGG 5g/day for 1 month

Arm Title

COPD without PHGG

Arm Type

No Intervention

Arm Description

COPD patient without PHGG 5g/day for 1 month

Arm Title

Healthy with PHGG

Arm Type

Active Comparator

Arm Description

Healthy PHGG 5g/day for 1 month

Arm Title

Healthy without PHGG

Arm Type

No Intervention

Arm Description

Healthy without PHGG 5g/day for 1 month

Intervention Type

Dietary Supplement

Intervention Name(s)

Partially Hydrolyzed Guar Gum (PHGG)

Intervention Description

Partially Hydrolyzed Guar Gum 5 gram/day for 1 month

Primary Outcome Measure Information:

Title

Modified Medical Research Council Dyspnea Scale (mMRC)

Description

change of mMRC scale, 0 the best, 4 the worst

Time Frame