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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05126654
• Other study ID #: FJUH110120
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2021
• Source: Fu Jen Catholic University Hospital
• Contact: Yen-Liang Kuo, MD
• Phone: 886-2-85128888
• Email: pforcekuo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COPD
• Infections
• Lung Diseases, Obstructive
• Microbial Colonization
• Pulmonary Disease, Chronic Obstructive
• Respiratory Tract Disease
• Respiratory Tract Diseases

Intervention

Dietary Supplement:
• Partially Hydrolyzed Guar Gum (PHGG)
Partially Hydrolyzed Guar Gum 5 gram/day for 1 month

Locations

Country	Name	City	State
Taiwan	Yen-Liang Kuo	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	COPD Assessment Test (CAT)	change of CAT (0 the best, 40 the worst)	after PHGG 5 gram/day for 1 month
Primary	St. George's Respiratory Questionnaire (SGRQ)	change of SGRQ score, 0 the best, 100 the worst	after PHGG 5 gram/day for 1 month
Primary	FEV1	change of FEV1	after PHGG 5 gram/day for 1 month
Primary	FEV1%	change of FEV1%	after PHGG 5 gram/day for 1 month
Primary	FVC	change of FVC	after PHGG 5 gram/day for 1 month
Primary	FVC%	change of FVC%	after PHGG 5 gram/day for 1 month
Primary	FEV1/FVC%	change of FEV1/FVC%	after PHGG 5 gram/day for 1 month
Primary	FEV3	change of FEV3	after PHGG 5 gram/day for 1 month
Primary	FEV3%	change of FEV3%	after PHGG 5 gram/day for 1 month
Primary	FEV3/FVC%	change of FEV3/FVC%	after PHGG 5 gram/day for 1 month
Primary	MMEF	change of MMEF	after PHGG 5 gram/day for 1 month
Primary	MMEF%	change of MMEF%	after PHGG 5 gram/day for 1 month
Primary	PEF	change of PEF	after PHGG 5 gram/day for 1 month
Primary	PEF%	change of PEF%	after PHGG 5 gram/day for 1 month
Primary	blood cytokine	change of blood cytokine	after PHGG 5 gram/day for 1 month
Primary	Microbiota of stool	change of stool microbiota contribution	after PHGG 5 gram/day for 1 month