中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500115868
最近更新日期： Date of Last Refreshed on：	2025-12-31 17:44:39
注册时间： Date of Registration：	2025-12-31 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	Effects of GABA with Butyrate, GABA/Butyrate-producing Synbiotics on Pain Relief in Fibromyalgia: A Phase II, Multi-Center, Double-Blinded, Randomized-Controlled Trial
Public title：	Effects of GABA with Butyrate, GABA/Butyrate-producing Synbiotics on Pain Relief in Fibromyalgia: A Phase II, Multi-Center, Double-Blinded, Randomized-Controlled Trial
注册题目简写：
English Acronym：
研究课题的正式科学名称：	Effects of GABA with Butyrate, GABA/Butyrate-producing Synbiotics on Pain Relief in Fibromyalgia: A Phase II, Multi-Center, Double-Blinded, Randomized-Controlled Trial
Scientific title：	Effects of GABA with Butyrate, GABA/Butyrate-producing Synbiotics on Pain Relief in Fibromyalgia: A Phase II, Multi-Center, Double-Blinded, Randomized-Controlled Trial
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	Pik Yi HOU	研究负责人：	Mandy Hiu Man CHU
Applicant：	Pik Yi HOU	Study leader：	Mandy Hiu Man CHU
申请注册联系人电话： Applicant telephone：	+852 3505 2375	研究负责人电话： Study leader's telephone：	+852 3505 2375
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	gracehou@cuhk.edu.hk	研究负责人电子邮件： Study leader's E-mail：	hiumanchu@cuhk.edu.hk
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	Shatin, New Territories, Hong Kong	研究负责人通讯地址：	Shatin, New Territories, Hong Kong
Applicant address：	Shatin, New Territories, Hong Kong	Study leader's address：	Shatin, New Territories, Hong Kong
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong
Applicant's institution：	Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong
研究负责人所在单位：	Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong
Affiliation of the Leader：	Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2025.654	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee
Name of the ethic committee：	Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2025-11-25 00:00:00
伦理委员会联系人：	Envy LEE
Contact Name of the ethic committee：	Envy LEE
伦理委员会联系地址：	Shatin, New Territories, Hong Kong
Contact Address of the ethic committee：	Shatin, New Territories, Hong Kong
伦理委员会联系人电话： Contact phone of the ethic committee：	+852 3505 3935	伦理委员会联系人邮箱： Contact email of the ethic committee：	crec@cuhk.edu.hk

研究实施负责（组长）单位：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Shatin, New Territories, Hong Kong

Primary sponsor's address：

Shatin, New Territories, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	China	省(直辖市)：	Hong Kong	市(区县)：
Country：	China	Province：	Hong Kong	City：
单位(医院)：	Peter Hung Pain Research Institute	具体地址：	Rm 5, Block 2, CUHK Medical Centre, 30 Ngan Shing Street, Sha Tin, New Territories, Hong Kong
Institution hospital：	Peter Hung Pain Research Institute	Address：	Rm 5, Block 2, CUHK Medical Centre, 30 Ngan Shing Street, Sha Tin, New Territories, Hong Kong

经费或物资来源：

Peter Hung Pain Research Institute

Source(s) of funding：

Peter Hung Pain Research Institute

研究疾病：

Fibromyalgia

Target disease：

Fibromyalgia

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

II期临床试验

Study phase：

2

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

Objective: We would like to show that 1) combination of GABA and butyrate as a supplement and 2) GABA-butyrate producing synbiotics can reduce pain in patients with fibromyalgia better than placebo. With the effects on vagus nerves and enteric nervous system, GABA-butyrate or its producing synbiotics may also improve the functional outcomes of fibromyalgia patients with the interference of pain.

Objectives of Study：

Objective: We would like to show that 1) combination of GABA and butyrate as a supplement and 2) GABA-butyrate producing synbiotics can reduce pain in patients with fibromyalgia better than placebo. With the effects on vagus nerves and enteric nervous system, GABA-butyrate or its producing synbiotics may also improve the functional outcomes of fibromyalgia patients with the interference of pain.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1. Pregnant; 2. Known history of allergic reactions to maize, probiotics or prebiotics; 3. Using prebiotics and/ or probiotics within 15 days before enrolment; 4. Immunocompromised with (a) active chemotherapy or immunotherapy or (b) chronic leukopenia (with cell count < 4x10^9/L) within 3 months of enrolment.

Exclusion criteria：

1. Pregnant; 2. Known history of allergic reactions to maize, probiotics or prebiotics; 3. Using prebiotics and/ or probiotics within 15 days before enrolment; 4. Immunocompromised with (a) active chemotherapy or immunotherapy or (b) chronic leukopenia (with cell count < 4x10^9/L) within 3 months of enrolment.

研究实施时间：

Study execute time：

从 From 2026-01-02 00:00:00至 To 2028-03-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-01-02 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	GABA/Butyrate group	样本量：	50
Group：	GABA/Butyrate group	Sample size：	50
干预措施：	Purified GABA and butyrate in separately bottles respectively (Bottle 1 and Bottle 2). The patients will be instructed to take 1 capsule from Bottle 1 (500mg GABA) and 1 capsule from Bottle B (600mg Butyrate) twice a day, making it a total daily dose of 1gram of GABA and 1.2gram of butyrate every day.	干预措施代码：
Intervention：	Purified GABA and butyrate in separately bottles respectively (Bottle 1 and Bottle 2). The patients will be instructed to take 1 capsule from Bottle 1 (500mg GABA) and 1 capsule from Bottle B (600mg Butyrate) twice a day, making it a total daily dose of 1gram of GABA and 1.2gram of butyrate every day.	Intervention code：

组别：	Synbiotics Group	样本量：	50
Group：	Synbiotics Group	Sample size：	50
干预措施：	GABA-producing Synbiotics (Bifidobacterium longum ATCC 51870 + Lactobacillus plantarum 299v + 500mg Fructooligosaccharides) and Butyrate-producing Synbiotics (Lactobacillus rhamnosus LGG + 500 mg Fructooligosaccharides) will be prepared in separate bottles (Bottle 1 and Bottle 2). Patients will be instructed to take 1 capsule from each bottle twice a day	干预措施代码：
Intervention：	GABA-producing Synbiotics (Bifidobacterium longum ATCC 51870 + Lactobacillus plantarum 299v + 500mg Fructooligosaccharides) and Butyrate-producing Synbiotics (Lactobacillus rhamnosus LGG + 500 mg Fructooligosaccharides) will be prepared in separate bottles (Bottle 1 and Bottle 2). Patients will be instructed to take 1 capsule from each bottle twice a day	Intervention code：

组别：	Placebo Group	样本量：	50
Group：	Placebo Group	Sample size：	50
干预措施：	StarCap - a mixture of Pregelatinized Maize starch and maize starch. The patients will be provided with 2 bottles and instructed to take one capsule from each of the bottles twice a day	干预措施代码：
Intervention：	StarCap - a mixture of Pregelatinized Maize starch and maize starch. The patients will be provided with 2 bottles and instructed to take one capsule from each of the bottles twice a day	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	China	省(直辖市)：	Hong Kong	市(区县)：
Country：	China	Province：	Hong Kong	City：
单位(医院)：	Alice Ho Miu Ling Nethersole Hospital	单位级别：	N/A
Institution hospital：	Alice Ho Miu Ling Nethersole Hospital	Level of the institution：	N/A

国家：	China	省(直辖市)：	Hong Kong	市(区县)：
Country：	China	Province：	Hong Kong	City：
单位(医院)：	Kwong Wah Hospital	单位级别：	N/A
Institution hospital：	Kwong Wah Hospital	Level of the institution：	N/A

国家：	China	省(直辖市)：	Hong Kong	市(区县)：
Country：	China	Province：	Hong Kong	City：
单位(医院)：	Pamela Youde Nethersole Eastern Hospital	单位级别：	N/A
Institution hospital：	Pamela Youde Nethersole Eastern Hospital	Level of the institution：	N/A

国家：	China	省(直辖市)：	Hong Kong	市(区县)：
Country：	China	Province：	Hong Kong	City：
单位(医院)：	Tuen Mun Hospital	单位级别：	N/A
Institution hospital：	Tuen Mun Hospital	Level of the institution：	N/A

国家：	China	省(直辖市)：	Hong Kong	市(区县)：
Country：	China	Province：	Hong Kong	City：
单位(医院)：	United Christian Hospital	单位级别：	N/A
Institution hospital：	United Christian Hospital	Level of the institution：	N/A

国家：	China	省(直辖市)：	Hong Kong	市(区县)：
Country：	China	Province：	Hong Kong	City：
单位(医院)：	CUHK Medical Centre	单位级别：	N/A
Institution hospital：	CUHK Medical Centre	Level of the institution：	N/A

测量指标：

Outcomes：

指标中文名：	average of pain severity score	指标类型：	主要指标
Outcome：	average of pain severity score	Type：	Primary indicator
测量时间点：	baseline, 6 months	测量方法：
Measure time point of outcome：	baseline, 6 months	Measure method：

指标中文名：	average of pain severity score	指标类型：	次要指标
Outcome：	average of pain severity score	Type：	Secondary indicator
测量时间点：	baseline, 1 month, 3 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 1 month, 3 months, 12 months	Measure method：

指标中文名：	pain interference score	指标类型：	次要指标
Outcome：	pain interference score	Type：	Secondary indicator
测量时间点：	baseline, 6 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 6 months, 12 months	Measure method：

指标中文名：	Depression Anxiety Stress Scale	指标类型：	次要指标
Outcome：	Depression Anxiety Stress Scale	Type：	Secondary indicator
测量时间点：	baseline, 3 months, 6 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 3 months, 6 months, 12 months	Measure method：

指标中文名：	Pittsburgh Sleeping Quality Index	指标类型：	次要指标
Outcome：	Pittsburgh Sleeping Quality Index	Type：	Secondary indicator
测量时间点：	baseline, 3 months, 6 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 3 months, 6 months, 12 months	Measure method：

指标中文名：	plasma GABA level	指标类型：	次要指标
Outcome：	plasma GABA level	Type：	Secondary indicator
测量时间点：	baseline, 6 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 6 months, 12 months	Measure method：

指标中文名：	fecal GABA level	指标类型：	次要指标
Outcome：	fecal GABA level	Type：	Secondary indicator
测量时间点：	baseline, 6 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 6 months, 12 months	Measure method：

指标中文名：	plasma butyrate level	指标类型：	次要指标
Outcome：	plasma butyrate level	Type：	Secondary indicator
测量时间点：	baseline, 6 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 6 months, 12 months	Measure method：

指标中文名：	fecal butyrate level	指标类型：	次要指标
Outcome：	fecal butyrate level	Type：	Secondary indicator
测量时间点：	baseline, 6 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 6 months, 12 months	Measure method：

指标中文名：	I-FABP level	指标类型：	次要指标
Outcome：	I-FABP level	Type：	Secondary indicator
测量时间点：	baseline, 6 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 6 months, 12 months	Measure method：

指标中文名：	bacterial DNA level	指标类型：	次要指标
Outcome：	bacterial DNA level	Type：	Secondary indicator
测量时间点：	baseline, 6 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 6 months, 12 months	Measure method：

指标中文名：	16S RNA gene sequencing	指标类型：	次要指标
Outcome：	16S RNA gene sequencing	Type：	Secondary indicator
测量时间点：	baseline, 6 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 6 months, 12 months	Measure method：

指标中文名：	fecal calprotectin	指标类型：	次要指标
Outcome：	fecal calprotectin	Type：	Secondary indicator
测量时间点：	baseline, 6 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 6 months, 12 months	Measure method：

指标中文名：	metagenomic and metabolomic	指标类型：	次要指标
Outcome：	metagenomic and metabolomic	Type：	Secondary indicator
测量时间点：	baseline, 6 months, 12 months	测量方法：
Measure time point of outcome：	baseline, 6 months, 12 months	Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	plasma	组织：
Sample Name：	plasma	Tissue：
人体标本去向	使用后保存	说明	10 years
Fate of sample：	Preservation after use	Note：	10 years

标本中文名：	stool	组织：
Sample Name：	stool	Tissue：
人体标本去向	使用后保存	说明	10 years
Fate of sample：	Preservation after use	Note：	10 years

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age		岁 years
最大 Max age		岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Block randomization will be used in our trial. We are aware that it is a multicentre trial involving 7 pain centres in Hong Kong in which the inter-centre variability is unlikely to be negligible. The randomization will be stratified in each center so to have similar distribution of each study arm in each center

Randomization Procedure (please state who generates the random number sequence and by what method)：

Block randomization will be used in our trial. We are aware that it is a multicentre trial involving 7 pain centres in Hong Kong in which the inter-centre variability is unlikely to be negligible. The randomization will be stratified in each center so to have similar distribution of each study arm in each center

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	This is a double-blinded study in which both the assessors and the patients will be blinded. The bottles, though not completely identical between different arms, the content would not be distinguishable by the appearance of the bottles. Labelling will show only the study arms and bottle A or B respectively.
Blinding：	This is a double-blinded study in which both the assessors and the patients will be blinded. The bottles, though not completely identical between different arms, the content would not be distinguishable by the appearance of the bottles. Labelling will show only the study arms and bottle A or B respectively.

是否共享原始数据： IPD sharing	否No
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	None
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	None
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	REDCap database
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	REDCap database
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2025-12-31 17:44:31