跳至主要内容
临床试验/NCT05126654
NCT05126654Unknown不适用

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

Fu Jen Catholic University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
FEV1/FVC%

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age of 40-85 years
  • •diagnosis of COPD made by pulmonologist
  • •provision of written informed consent

排除标准

  • •severe and unstable comorbidities or active malignancy
  • •COPD exacerbation within the 4 weeks prior
  • •cognitive impairment or a psychiatric disorder
  • •pregnancy

研究组 & 干预措施

COPD with PHGG

Experimental

COPD patient PHGG 5g/day for 1 month

干预措施: Partially Hydrolyzed Guar Gum (PHGG) (Dietary Supplement)

COPD without PHGG

No Intervention

COPD patient without PHGG 5g/day for 1 month

Healthy with PHGG

Active Comparator

Healthy PHGG 5g/day for 1 month

干预措施: Partially Hydrolyzed Guar Gum (PHGG) (Dietary Supplement)

Healthy without PHGG

No Intervention

Healthy without PHGG 5g/day for 1 month

结局指标

主要结局

FEV1/FVC%

时间窗: after PHGG 5 gram/day for 1 month

change of FEV1/FVC%

St. George's Respiratory Questionnaire (SGRQ)

时间窗: after PHGG 5 gram/day for 1 month

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

MMEF%

时间窗: after PHGG 5 gram/day for 1 month

change of MMEF%

Microbiota of stool

时间窗: after PHGG 5 gram/day for 1 month

change of stool microbiota contribution

FEV1

时间窗: after PHGG 5 gram/day for 1 month

change of FEV1

FEV3/FVC%

时间窗: after PHGG 5 gram/day for 1 month

change of FEV3/FVC%

PEF

时间窗: after PHGG 5 gram/day for 1 month

change of PEF

Modified Medical Research Council Dyspnea Scale (mMRC)

时间窗: after PHGG 5 gram/day for 1 month

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

COPD Assessment Test (CAT)

时间窗: after PHGG 5 gram/day for 1 month

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

FEV1%

时间窗: after PHGG 5 gram/day for 1 month

change of FEV1%

FVC

时间窗: after PHGG 5 gram/day for 1 month

change of FVC

FVC%

时间窗: after PHGG 5 gram/day for 1 month

change of FVC%

FEV3

时间窗: after PHGG 5 gram/day for 1 month

change of FEV3

FEV3%

时间窗: after PHGG 5 gram/day for 1 month

change of FEV3%

MMEF

时间窗: after PHGG 5 gram/day for 1 month

change of MMEF

PEF%

时间窗: after PHGG 5 gram/day for 1 month

change of PEF%

blood cytokine

时间窗: after PHGG 5 gram/day for 1 month

change of blood cytokine

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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