COPDNCT05126654
Partially Hydrolyzed Guar Gum (PHGG) for Amelioration of Chronic Obstructive Pulmonary Disease (COPD)
A study testing Partially Hydrolyzed Guar Gum (PHGG) in people with COPD and Microbial Colonization, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD, Microbial Colonization, Respiratory Tract Disease
- What is being tested?
- Partially Hydrolyzed Guar Gum (PHGG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age of 40-85 years
- diagnosis of COPD made by pulmonologist
- provision of written informed consent
Who cannot join
- severe and unstable comorbidities or active malignancy
- COPD exacerbation within the 4 weeks prior
- cognitive impairment or a psychiatric disorder
- pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Yen-Liang Kuo
New Taipei City, 24205
Yen-Liang Kuo, MD, pforcekuo@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD, Microbial Colonization, Respiratory Tract Disease
- Being tested
- Partially Hydrolyzed Guar Gum (PHGG)
- Keywords
- COPD, Gut microbiota, Respiratory tract, prebiotics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Communicable Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially Hydrolyzed Guar Gum (PHGG)Dietary supplement
Partially Hydrolyzed Guar Gum 5 gram/day for 1 month
| Study group | Role | What they receive |
|---|---|---|
| COPD with PHGG | Experimental | COPD patient PHGG 5g/day for 1 month Receives: 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 Receives: Dietary Supplement: Partially Hydrolyzed Guar Gum (PHGG) |
| Healthy without PHGG | No intervention | Healthy without PHGG 5g/day for 1 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Medical Research Council Dyspnea Scale (mMRC)
change of mMRC scale, 0 the best, 4 the worst
Measured: after PHGG 5 gram/day for 1 month
COPD Assessment Test (CAT)
change of CAT (0 the best, 40 the worst)
Measured: after PHGG 5 gram/day for 1 month
St. George's Respiratory Questionnaire (SGRQ)
change of SGRQ score, 0 the best, 100 the worst
Measured: after PHGG 5 gram/day for 1 month
FEV1
change of FEV1
Measured: after PHGG 5 gram/day for 1 month
FEV1%
change of FEV1%
Measured: after PHGG 5 gram/day for 1 month
FVC
change of FVC
Measured: after PHGG 5 gram/day for 1 month
FVC%
change of FVC%
Measured: after PHGG 5 gram/day for 1 month
FEV1/FVC%
change of FEV1/FVC%
Measured: after PHGG 5 gram/day for 1 month
FEV3
change of FEV3
Measured: after PHGG 5 gram/day for 1 month
FEV3%
change of FEV3%
Measured: after PHGG 5 gram/day for 1 month
FEV3/FVC%
change of FEV3/FVC%
Measured: after PHGG 5 gram/day for 1 month
MMEF
change of MMEF
Measured: after PHGG 5 gram/day for 1 month
MMEF%
change of MMEF%
Measured: after PHGG 5 gram/day for 1 month
PEF
change of PEF
Measured: after PHGG 5 gram/day for 1 month
PEF%
change of PEF%
Measured: after PHGG 5 gram/day for 1 month
blood cytokine
change of blood cytokine
Measured: after PHGG 5 gram/day for 1 month
Microbiota of stool
change of stool microbiota contribution
Measured: after PHGG 5 gram/day for 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Chen Lu, PhD, Principal investigator, Department of Respiratory Therapy, College of Medicine, Fu-Jen Catholic University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126654
- Sponsor's protocol ID
- FJUH110120
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Partially Hydrolyzed Guar Gum (PHGG) Based Synbiotic for Amelioration of Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT05126654
- Acronym / sponsor ID
- FJUH110120
- Conditions
- COPD, Microbial Colonization, Respiratory Tract Disease
- Keywords
- COPD, Gut microbiota, Respiratory tract, prebiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COPD with PHGG | Experimental | Dietary Supplement: Partially Hydrolyzed Guar Gum (PHGG)COPD patient PHGG 5g/day for 1 month |
| COPD without PHGG | No intervention | –COPD patient without PHGG 5g/day for 1 month |
| Healthy with PHGG | Active comparator | Dietary Supplement: Partially Hydrolyzed Guar Gum (PHGG)Healthy PHGG 5g/day for 1 month |
| Healthy without PHGG | No intervention | –Healthy without PHGG 5g/day for 1 month |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age of 40-85 years
- diagnosis of COPD made by pulmonologist
- provision of written informed consent
Key exclusion criteria (4 listed)
- severe and unstable comorbidities or active malignancy
- COPD exacerbation within the 4 weeks prior
- cognitive impairment or a psychiatric disorder
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partially Hydrolyzed Guar Gum (PHGG)Partially Hydrolyzed Guar Gum 5 gram/day for 1 month | Dietary supplement | COPD with PHGG, Healthy with PHGG |
Primary outcome
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
COPD Assessment Test (CAT)
Time frame: after PHGG 5 gram/day for 1 month
change of CAT (0 the best, 40 the worst)
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
FEV1
Time frame: after PHGG 5 gram/day for 1 month
change of FEV1
FEV1%
Time frame: after PHGG 5 gram/day for 1 month
change of FEV1%
FVC
Time frame: after PHGG 5 gram/day for 1 month
change of FVC
FVC%
Time frame: after PHGG 5 gram/day for 1 month
change of FVC%
FEV1/FVC%
Time frame: after PHGG 5 gram/day for 1 month
change of FEV1/FVC%
FEV3
Time frame: after PHGG 5 gram/day for 1 month
change of FEV3
FEV3%
Time frame: after PHGG 5 gram/day for 1 month
change of FEV3%
FEV3/FVC%
Time frame: after PHGG 5 gram/day for 1 month
change of FEV3/FVC%
MMEF
Time frame: after PHGG 5 gram/day for 1 month
change of MMEF
MMEF%
Time frame: after PHGG 5 gram/day for 1 month
change of MMEF%
PEF
Time frame: after PHGG 5 gram/day for 1 month
change of PEF
PEF%
Time frame: after PHGG 5 gram/day for 1 month
change of PEF%
blood cytokine
Time frame: after PHGG 5 gram/day for 1 month
change of blood cytokine
Microbiota of stool
Time frame: after PHGG 5 gram/day for 1 month
change of stool microbiota contribution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Chen Lu, PhD principal investigator
Department of Respiratory Therapy, College of Medicine, Fu-Jen Catholic University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partially Hydrolyzed Guar Gum (PHGG) in people with COPD and Microbial Colonization, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yen-Liang Kuo, MD (886-2-85128888 ext. 22030, pforcekuo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Medical Research Council Dyspnea Scale (mMRC) (time frame: after PHGG 5 gram/day for 1 month). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.