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

• Sponsor: Fu Jen Catholic University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05126654
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD; Microbial Colonization; Respiratory Tract Disease	Dietary Supplement: Partially Hydrolyzed Guar Gum (PHGG)	N/A

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

1. 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

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Development of a Partially Hydrolyzed Guar Gum (PHGG) Based Synbiotic for Amelioration of Chronic Obstructive Pulmonary Disease (COPD)
• Actual Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COPD with PHGG COPD patient PHGG 5g/day for 1 month	Dietary Supplement: Partially Hydrolyzed Guar Gum (PHGG); Partially Hydrolyzed Guar Gum 5 gram/day for 1 month
No Intervention: COPD without PHGG COPD patient without PHGG 5g/day for 1 month
Active Comparator: Healthy with PHGG Healthy PHGG 5g/day for 1 month	Dietary Supplement: Partially Hydrolyzed Guar Gum (PHGG); Partially Hydrolyzed Guar Gum 5 gram/day for 1 month
No Intervention: Healthy without PHGG Healthy without PHGG 5g/day for 1 month

Outcome Measures

Primary Outcome Measures

1. 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

2. COPD Assessment Test (CAT) [after PHGG 5 gram/day for 1 month]

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

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

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

4. FEV1 [after PHGG 5 gram/day for 1 month]

   change of FEV1

5. FEV1% [after PHGG 5 gram/day for 1 month]

   change of FEV1%

6. FVC [after PHGG 5 gram/day for 1 month]

   change of FVC

7. FVC% [after PHGG 5 gram/day for 1 month]

   change of FVC%

8. FEV1/FVC% [after PHGG 5 gram/day for 1 month]

   change of FEV1/FVC%

9. FEV3 [after PHGG 5 gram/day for 1 month]

   change of FEV3

10. FEV3% [after PHGG 5 gram/day for 1 month]

    change of FEV3%

11. FEV3/FVC% [after PHGG 5 gram/day for 1 month]

    change of FEV3/FVC%

12. MMEF [after PHGG 5 gram/day for 1 month]

    change of MMEF

13. MMEF% [after PHGG 5 gram/day for 1 month]

    change of MMEF%

14. PEF [after PHGG 5 gram/day for 1 month]

    change of PEF

15. PEF% [after PHGG 5 gram/day for 1 month]

    change of PEF%

16. blood cytokine [after PHGG 5 gram/day for 1 month]

    change of blood cytokine

17. Microbiota of stool [after PHGG 5 gram/day for 1 month]

    change of stool microbiota contribution

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yen-Liang Kuo	New Taipei City		Taiwan	24205

Sponsors and Collaborators

• Fu Jen Catholic University Hospital

Investigators

• Principal Investigator: Chia-Chen Lu, PhD, Department of Respiratory Therapy, College of Medicine, Fu-Jen Catholic University, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fu Jen Catholic University Hospital
• ClinicalTrials.gov Identifier: NCT05126654
• Other Study ID Numbers: FJUH110120
• First Posted: Nov 19, 2021
• Last Update Posted: Nov 19, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fu Jen Catholic University Hospital: COPD; Gut microbiota; Respiratory tract; prebiotics
• Additional relevant MeSH terms: Communicable Diseases; Infections; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases

Study Results

No Results Posted as of Nov 19, 2021