Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Occurence of anemia
研究概览
简要总结
The goal of the study is to determine the effect of supplementation of the d piger strain on intestinal ethanol production in individuals with overweight.
The investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses.
详细描述
The investigators perform a randomized, placebo controlled trial in 2x10 participants.
The participants will be given placebo or d piger as an oral suspension once daily for 30 days.
At baseline and after 30 days, a fructose challenge test with fomepizole, gastroduodenoscopy and MRI liver + FibroScan will be performed. Patient will attend the clinical trial unit weekly for safety visits.
The participants will be overweight males or females age 18-70 with impaired glucose tolerance.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The pharmacist will provide the study intervention to the investigator in a coded fashion. Both the investigator and the participant are blinded.
In case of emergency, an unblinding protocol is activated.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or (postmenopausal) females
- •Increased waist circumference (>102 cm men, 88>cm women)
- •Insulin resistance (HOMA>2.5)
- •18-70 years
排除标准
- •Use of systemic medication (except for paracetamol), including antibiotics and pro-/prebiotics in the past three months or during the study period.
- •A history of a cardiovascular event
- •A history of cholecystectomy
- •Overt untreated gastrointestinal disease or abnormal bowel habits
- •Liver enzymes>2.5 fold higher than the upper limit of normal range
- •Alcohol abuse
结局指标
主要结局
Occurence of anemia
时间窗: 30 days
Number of patients with Hb \< 8,5 mmol/L
Changes in leucocytes
时间窗: 30 days
Number of patients with leucocytes \<4,0 or \>10,5 x10E9 cells/L
Changes in aspartate aminotransferase (AST)
时间窗: 30 days
Number of patients with AST \> 43 IU/L
adverse events
时间窗: 30 days
the number of adverse events in both groups
Changes in alanine aminotransferase (ALT)
时间窗: 30 days
Number of patients with ALT \> 45 IU/L
Changes in total bilirubin
时间窗: 30 days
Number of patients with total bilirubin \> 24 micromol/L
Gut engraftment
时间窗: 30 days
the number of reads of d piger in feces using q pcr
Renal function
时间窗: 30 days
Number of participants with a decreased kidney function, defined as a rise in serum creatinine of \>26,5 micromol/L in 48 h
Changes in alkaline phosphatase (ALP)
时间窗: 30 days
Number of patients with ALP \> 126 IU/L
Changes in Gamma-glutamyltransferase (GGT)
时间窗: 30 days
Number of patients with GGT \> 117 IU/L
Changes in thrombocytes
时间窗: 30 days
Number of patients with thrombocytes \<150 x 10E9 cells/
次要结局
- Fructose in peripheral blood(30 days)
- Dietary intake(30 days)
- Time-in-range(30 days)
- Continuous glucose monitoring(30 days)
- Bioreactor analyses(30 days)
- Fructose metabolites in breath(30 days)
- Glycemic control(30 days)
- Intestinal microbiota composition(30 days)
- MRI(30 days)
- FibroScan(30 days)
- Fructose metabolites in urine(30 days)
- Questionnaires(30 days)
- Fructose metabolites in feces(30 days)
研究者
Max Nieuwdorp
Principal Investigator
Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC)