NCT05126654

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 19, 2021

Status Verified

October 1, 2021

Enrollment Period

2.2 years

First QC Date

October 12, 2021

Last Update Submit

November 18, 2021

Conditions

COPDMicrobial ColonizationRespiratory Tract Disease

Keywords

COPDGut microbiotaRespiratory tractprebiotics

Outcome Measures

Primary Outcomes (17)

  • Modified Medical Research Council Dyspnea Scale (mMRC)

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

    after PHGG 5 gram/day for 1 month

  • COPD Assessment Test (CAT)

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

    after PHGG 5 gram/day for 1 month

  • St. George's Respiratory Questionnaire (SGRQ)

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

    after PHGG 5 gram/day for 1 month

  • FEV1

    change of FEV1

    after PHGG 5 gram/day for 1 month

  • FEV1%

    change of FEV1%

    after PHGG 5 gram/day for 1 month

  • FVC

    change of FVC

    after PHGG 5 gram/day for 1 month

  • FVC%

    change of FVC%

    after PHGG 5 gram/day for 1 month

  • FEV1/FVC%

    change of FEV1/FVC%

    after PHGG 5 gram/day for 1 month

  • FEV3

    change of FEV3

    after PHGG 5 gram/day for 1 month

  • FEV3%

    change of FEV3%

    after PHGG 5 gram/day for 1 month

  • FEV3/FVC%

    change of FEV3/FVC%

    after PHGG 5 gram/day for 1 month

  • MMEF

    change of MMEF

    after PHGG 5 gram/day for 1 month

  • MMEF%

    change of MMEF%

    after PHGG 5 gram/day for 1 month

  • PEF

    change of PEF

    after PHGG 5 gram/day for 1 month

  • PEF%

    change of PEF%

    after PHGG 5 gram/day for 1 month

  • blood cytokine

    change of blood cytokine

    after PHGG 5 gram/day for 1 month

  • Microbiota of stool

    change of stool microbiota contribution

    after PHGG 5 gram/day for 1 month

Study Arms (4)

COPD with PHGG

EXPERIMENTAL

COPD patient PHGG 5g/day for 1 month

Dietary Supplement: Partially Hydrolyzed Guar Gum (PHGG)

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

Dietary Supplement: Partially Hydrolyzed Guar Gum (PHGG)

Healthy without PHGG

NO INTERVENTION

Healthy without PHGG 5g/day for 1 month

Interventions

Partially Hydrolyzed Guar Gum (PHGG)DIETARY_SUPPLEMENT

Partially Hydrolyzed Guar Gum 5 gram/day for 1 month

COPD with PHGGHealthy with PHGG

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yen-Liang Kuo

New Taipei City, 24205, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCommunicable DiseasesRespiratory Tract Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInfections

Study Officials

  • Chia-Chen Lu, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen-Liang Kuo, MD

CONTACT

886-2-85128888pforcekuo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2021

First Posted

November 19, 2021

Study Start

November 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

November 19, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)