Clinical trial NCT05126654: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Microbial Colonization
Respiratory Tract Disease
Keywords: COPD
Gut microbiota
Respiratory tract
prebiotics
Lead sponsor: Fu Jen Catholic University Hospital
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Medical Research Council Dyspnea Scale (mMRC)
timeFrame: after PHGG 5 gram/day for 1 month
measure: COPD Assessment Test (CAT)
timeFrame: after PHGG 5 gram/day for 1 month
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: after PHGG 5 gram/day for 1 month
measure: FEV1
timeFrame: after PHGG 5 gram/day for 1 month
measure: FEV1%
timeFrame: after PHGG 5 gram/day for 1 month
measure: FVC
timeFrame: after PHGG 5 gram/day for 1 month
measure: FVC%
timeFrame: after PHGG 5 gram/day for 1 month
measure: FEV1/FVC%
timeFrame: after PHGG 5 gram/day for 1 month
measure: FEV3
timeFrame: after PHGG 5 gram/day for 1 month
measure: FEV3%
timeFrame: after PHGG 5 gram/day for 1 month
measure: FEV3/FVC%
timeFrame: after PHGG 5 gram/day for 1 month
measure: MMEF
timeFrame: after PHGG 5 gram/day for 1 month
measure: MMEF%
timeFrame: after PHGG 5 gram/day for 1 month
measure: PEF
timeFrame: after PHGG 5 gram/day for 1 month
measure: PEF%
timeFrame: after PHGG 5 gram/day for 1 month
measure: blood cytokine
timeFrame: after PHGG 5 gram/day for 1 month
measure: Microbiota of stool
timeFrame: after PHGG 5 gram/day for 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Yen-Liang Kuo
Study officials:
affiliation: Department of Respiratory Therapy, College of Medicine, Fu-Jen Catholic University, Taiwan
name: Chia-Chen Lu, PhD
role: PRINCIPAL_INVESTIGATOR
References: