Development of a Partially Hydrolyzed Guar Gum (PHGG) Based Synbiotic for Amelioration of Chronic Obstructive Pulmonary Disease (COPD)
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
COPD patient PHGG 5g/day for 1 month
干预措施: Partially Hydrolyzed Guar Gum (PHGG) (Dietary Supplement)
COPD without PHGG
COPD patient without PHGG 5g/day for 1 month
Healthy with PHGG
Healthy PHGG 5g/day for 1 month
干预措施: Partially Hydrolyzed Guar Gum (PHGG) (Dietary Supplement)
Healthy without PHGG
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
