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

Not Applicable
Conditions
Microbial Colonization
Respiratory Tract Disease
COPD
Interventions
Dietary Supplement: Partially Hydrolyzed Guar Gum (PHGG)
Registration Number
NCT05126654
Lead Sponsor
Fu Jen Catholic University Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
COPD with PHGGPartially Hydrolyzed Guar Gum (PHGG)COPD patient PHGG 5g/day for 1 month
Healthy with PHGGPartially Hydrolyzed Guar Gum (PHGG)Healthy PHGG 5g/day for 1 month
Primary Outcome Measures
NameTimeMethod
FEV1after PHGG 5 gram/day for 1 month

change of FEV1

St. George's Respiratory Questionnaire (SGRQ)after PHGG 5 gram/day for 1 month

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

FEV1/FVC%after PHGG 5 gram/day for 1 month

change of FEV1/FVC%

MMEF%after PHGG 5 gram/day for 1 month

change of MMEF%

Microbiota of stoolafter PHGG 5 gram/day for 1 month

change of stool microbiota contribution

PEFafter PHGG 5 gram/day for 1 month

change of PEF

FEV3/FVC%after PHGG 5 gram/day for 1 month

change of FEV3/FVC%

Modified Medical Research Council Dyspnea Scale (mMRC)after PHGG 5 gram/day for 1 month

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

COPD Assessment Test (CAT)after PHGG 5 gram/day for 1 month

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

FEV1%after PHGG 5 gram/day for 1 month

change of FEV1%

FVCafter PHGG 5 gram/day for 1 month

change of FVC

FVC%after PHGG 5 gram/day for 1 month

change of FVC%

FEV3after PHGG 5 gram/day for 1 month

change of FEV3

FEV3%after PHGG 5 gram/day for 1 month

change of FEV3%

MMEFafter PHGG 5 gram/day for 1 month

change of MMEF

PEF%after PHGG 5 gram/day for 1 month

change of PEF%

blood cytokineafter PHGG 5 gram/day for 1 month

change of blood cytokine

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Yen-Liang Kuo

🇨🇳

New Taipei City, Taiwan

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