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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Microbial Colonization, Respiratory Tract Disease, COPD

Intervention / Treatment
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* Dietary Supplement: Partially Hydrolyzed Guar Gum (PHGG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD with PHGG<br>COPD patient PHGG 5g/day for 1 month | Dietary Supplement: Partially Hydrolyzed Guar Gum (PHGG)<br>* Partially Hydrolyzed Guar Gum 5 gram/day for 1 month<br>|
| No Intervention: COPD without PHGG<br>COPD patient without PHGG 5g/day for 1 month | |
| Active Comparator: Healthy with PHGG<br>Healthy PHGG 5g/day for 1 month | Dietary Supplement: Partially Hydrolyzed Guar Gum (PHGG)<br>* Partially Hydrolyzed Guar Gum 5 gram/day for 1 month<br>|
| No Intervention: Healthy without PHGG<br>Healthy without PHGG 5g/day for 1 month | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Gut microbiota, Respiratory tract, prebiotics