ChiCTR2500115868尚未招募2 期
Effects of GABA with Butyrate, GABA/Butyrate-producing Synbiotics on Pain Relief in Fibromyalgia: A Phase II, Multi-Center, Double-Blinded, Randomized-Controlled Trial
Peter Hung Pain Research Institute6 个研究点 分布在 1 个国家开始时间: 2026年1月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 试验地点
- 6
- 主要终点
- average of pain severity score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- Double
入排标准
- 性别
- All
入选标准
- •Patients who are >=18 years old, under care of the pain clinics in the collaborating hospitals;
- •FM has been diagnosed according to the revised 2016 American College of Rheumatology (ACR) Preliminary Diagnostic Criteria for FM, and
- •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
- •Known history of allergic reactions to maize, probiotics or prebiotics;
- •Using prebiotics and/ or probiotics within 15 days before enrolment;
- •Immunocompromised with (a) active chemotherapy or immunotherapy or (b) chronic leukopenia (with cell count < 4x10^9/L) within 3 months of enrolment.
研究组 & 干预措施
GABA/Butyrate group
Synbiotics Group
Placebo Group
结局指标
主要结局
average of pain severity score
时间窗: baseline, 6 months
次要结局
- average of pain severity score(baseline, 1 month, 3 months, 12 months)
- pain interference score(baseline, 6 months, 12 months)
- Depression Anxiety Stress Scale(baseline, 3 months, 6 months, 12 months)
- Pittsburgh Sleeping Quality Index(baseline, 3 months, 6 months, 12 months)
- plasma GABA level(baseline, 6 months, 12 months)
- fecal GABA level(baseline, 6 months, 12 months)
- plasma butyrate level(baseline, 6 months, 12 months)
- fecal butyrate level(baseline, 6 months, 12 months)
- I-FABP level(baseline, 6 months, 12 months)
- bacterial DNA level(baseline, 6 months, 12 months)
- 16S RNA gene sequencing(baseline, 6 months, 12 months)
- fecal calprotectin(baseline, 6 months, 12 months)
- metagenomic and metabolomic(baseline, 6 months, 12 months)
研究者
研究点 (6)
Loading locations...
相似试验
招募中
2 期
Acute Effects of Partial GABA(A)-Receptor Modulation by GT-002 on Psychophysiological Measures: The TOTEMS Phase II Clinical Trial Targeting Cognitive Impairment Associated with Schizophrenia2024-519389-28-00Region Hovedstadens Psykiatriske50
Unknown
不适用
食源性γ-氨基丁酸附加治疗抑郁症认知损害的疗效及生物机制探索——双盲、随机、对照研究ChiCTR2400081252北京安定医院人才引进科技配套经费
Unknown
不适用
食源性 GABA 治疗轻、中度焦虑障碍的随机、双盲、安慰剂对照研究ChiCTR2400082462科技部-科技创新 2030 - 脑科学与类脑研究（焦虑障碍快速起效与精准治疗新型干预技术研发与验证）
尚未招募
Phase 3 4
A study to compare the role of bacopa monnieri mother and individulaized homoeopathic medicine in treating slow learning childrenCTRI/2024/06/069191Sarada Krishna Homoeopathic Medical College60
招募中
3 期
Prefrontal Glutamatergic Modulation by NAC and MBCT for Depression in YouthNCT07464886University of Cincinnati160