【ChiCTR2500115868】Effects of GABA with Butyrate, GABA/Butyrate-producing Synbiotics on Pain Relief in Fibromyalgia: A Phase II, Multi-Center, Double-Blinded, Randomized-Controlled Trial

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基本信息

登记号

ChiCTR2500115868

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2025-12-31

临床申请受理号

靶点

适应症

Fibromyalgia

试验通俗题目

Effects of GABA with Butyrate, GABA/Butyrate-producing Synbiotics on Pain Relief in Fibromyalgia: A Phase II, Multi-Center, Double-Blinded, Randomized-Controlled Trial

试验专业题目

Effects of GABA with Butyrate, GABA/Butyrate-producing Synbiotics on Pain Relief in Fibromyalgia: A Phase II, Multi-Center, Double-Blinded, Randomized-Controlled Trial

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

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.

试验分类

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试验类型

随机平行对照

试验分期

Ⅱ期

随机化

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

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.

试验项目经费来源

Peter Hung Pain Research Institute

试验范围

目标入组人数

实际入组人数

第一例入组时间

2026-01-02

试验终止时间

2028-03-31

是否属于一致性

入选标准

1. Patients who are >=18 years old, under care of the pain clinics in the collaborating hospitals; 2. FM has been diagnosed according to the revised 2016 American College of Rheumatology (ACR) Preliminary Diagnostic Criteria for FM, and 3. Able to provide written informed consent and agree to adhere to the trial protocol and follow-up schedule for 12 months, including the 3-monthly follow-up for half a year and a follow-up at 1 year.；

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.；

研究者信息

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试验机构

The Chinese University of Hong Kong

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研究负责人邮编

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