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Effect of 4 Weeks of Oral Probiotic Desulfovibrio Piger Supplementation on Immunological and Metabolic Parameters in Individuals With Longstanding Type 1 Diabetes (PROSPER)

2026年5月10日 更新者：Max Nieuwdorp、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
The goal is to establish the effect of oral probiotic Desulfovibrio piger (D. piger) supplementation on immunological and metabolic parameters in individuals with longstanding type 1 diabetes with residual beta cell function. The investigators will perform a double-blind, randomized, placebo-controlled trial in 2x10 participants to measure effects of D. piger on parameters of systemic and intestinal inflammation and residual beta cell function.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The investigators perform a double-blind, randomized, placebo-controlled trial with two arms (10 participants per arm, total of 20 participants) in adults with longstanding type 1 diabetes with residual beta cell function. The study duration is 6 weeks, with 4 weeks of intervention in which participants will be given D. piger or placebo once daily and 2 weeks of washout period. The main study enpoints include the changes (versus baseline) in parameters of systemic/intestinal inflammation and beta cell function between the placebo and D.piger-treatment arms at the end of treatment (4 weeks). In addition, any long-lasting effects will be determined by assessing the changes in the above described markers after a 2 week washout period (6 weeks).

Secondary endpoints include glucose variability (continuous glucose monitoring, CGM), fecal microbiome composition (including strain engraftment of D. piger, plasma metabolites), immune cell phenotype and frequency and validated questionnaires (gastro-intestinal complaints) at these three timepoints (0,4,6 weeks).

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 荷兰
      • Amsterdam、荷兰、1105 AZ
      • Amsterdam、荷兰、1066 EC
        • 招聘中
        • Diabeter Centrum Amsterdam
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Males or females, age >18 years
  • A diagnosis of type 1 diabetes, with duration of more than 5 years, with minimally one of antiGAD65, IA2, ZnT8 autoantibodies present assessed at diagnosis or routine visits at Diabeter Centrum.
  • Evidence of remaining residual beta cell function with detectable UCPCR (more than 0.01 nmol/mmol C-peptide/creatinine ratio) and or fasting plasma C-peptide more than 0.2 mmol/L.
  • BMI 18-30 kg/m2

Exclusion Criteria:

  • Use of antibiotics or proton-pump inhibitors within the last three months before screening or during study period
  • Use of other probiotic supplementation within the last month before screening or during study period
  • A history of cholecystectomy
  • Overt untreated gastrointestinal disease, inflammatory bowel disease or abnormal bowel habits
  • Absence of a large bowel (ie colostomy)
  • Evidence for comprised immunity (HIV infection, chemotherapy, other autoimmune diseases, systemic anti-inflammatory therapy)
  • History of cardiovascular disaeses (CVD) events
  • Hepatic enzymes>2.5 higher than the upper limit of normal range, determined during MARVEL visits/routine visits
  • Kidney failure (eGFR <15ml.min/1.73m2), dialysis, kidney transplantation,
  • Inability or unwillingness to donate feces or urine.
  • Smoking or illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.
  • Alcohol abuse (equal or above 21 units per week)
  • Inability or unwillingness to provide informed consent.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Probiotic Desulfovibrio piger
Probiotic bacteria D. piger (10^9 colony forming units (CFU) in 10ml PBS containing 10% glycerol and 10% maltodextrin)
膳食补充剂：Probiotic dietary supplement
Probiotic bacteria D. piger (10^9 colony forming units (CFU) in 10ml PBS containing 10% glycerol and 10% maltodextrin)
安慰剂比较：Placebo
placebo (10ml PBS containing 10% glycerol and 10% maltodextrin)
膳食补充剂：Placebo
Placebo (10ml PBS containing 10% glycerol and 10% maltodextrin)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Parameters of systemic and intestinal inflammation
大体时间：From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.

systemic inflammation determined by measuring plasma CRP, and proinflammatory cytokines (IFNgamma, IFN alpha, TNFalpha)

intestinal inflammation assessed by LB, iFABP, zonulin in plasma
From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
Residual beta cell function
大体时间：From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
Assessed by C peptide AUC during mixed meal tolerance test and/or post meal urine C-peptide/creatinine ratio levels.
From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.

次要结果测量

结果测量
措施说明
大体时间
Glucose variability
大体时间：From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
percentage time in euglycemic range, time above range, time below range and glucose variability measured by continuous glucose monitoring (CGM)
From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
Immune cell phenotypes and frequency
大体时间：From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
Immunophenotyping by flow cytometry of PBMC (peripheral blood mononuclear cells) to determine frequency of T cell subsets with activation/exhaustion marker expression
From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
Fecal microbiome composition and strain engraftment
大体时间：From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
using 16s rRNA sequencing, primer-specific quantitative PCR for D. piger detection in feces and plasma metabolites
From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
Gastrointestinal Symptom Rating Scale (GSRS)
大体时间：From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.
Questionnaire. The minimum and maximum score are 15 and 105 points respectively, and a higher score in the scale reflects more gastro-intestinal complaints.
From start treatment to the end of treatment at 4 weeks and washout at 6 weeks.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

调查人员

  • 首席研究员：Max Nieuwdorp, Prof. Dr.、Amsterdam UMC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月10日

首次发布 (实际的)

2026年5月14日

研究记录更新

最后更新发布 (实际的)

2026年5月14日

上次提交的符合 QC 标准的更新

2026年5月10日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2025.1139

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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