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MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO) (FEMPTO)

2026年8月18日 更新者：University of Nottingham

A Feasibility Study Evaluating MRI Parameters as Biomarkers of the Effect of a Secretagogue in Cystic Fibrosis (FEMPTO)

Cystic fibrosis (CF) is an inherited condition that affects several organs, including the gut. People with CF often experience uncomfortable digestive symptoms such as bloating, gas, abdominal pain, and constipation. The root cause is that the gut produces thicker-than-normal mucus, which slows things down and makes it harder for the bowel to work properly.

Current treatments such as laxatives, enemas, or surgery can be inconvenient and don't always work well. There is a real need for better options, and for a clearer understanding of how the CF gut behaves and responds to treatment.

This study will use MRI, a non-invasive imaging technique, to look at how fluid moves through the gut in adults with CF and the impact of linaclotide. Linaclotide is a licensed medication used to treat chronic constipation and irritable bowel syndrome. It works by encouraging the gut to release more fluid, helping things move more easily. It acts locally in the gut and is not absorbed into the bloodstream. Early research suggests it may help in CF in a way that does not rely on correcting the underlying genetic fault, making it a promising avenue to explore.

Participants will include people with different bowel habits, including those who tend towards constipation and those who tend towards diarrhoea. The scans will help researchers check whether certain MRI measurements can reliably detect changes in gut fluid and movement.

This is a feasibility study; its main objective is to test whether these MRI measurements are useful and practical, and support a sample size calculation, in future CF studies investigating linaclotide effects.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Background: The recent James Lind Alliance priority setting listed "How can we relieve gastro-intestinal symptoms, such as stomach pain, bloating and nausea?" as number 3 priority despite treatment with CFTR modulators. The investigators have shown using magnetic resonance imaging (MRI) that pwCF have abnormal small bowel contents which empty more slowly into the colon. This is most likely due to impaired pancreatic, biliary and intestinal secretions leading to hyperviscosity of contents. Linaclotide is a drug which stimulates bicarbonate secretion in the small intestine which has been shown to accelerate transit in mice models of CF but not in patients. Its action would be predicted to reduce mucus viscosity and normalise small bowel contents and transit.

Aims: to perform a mechanistic pilot study using MRI to show that linaclotide normalises small bowel contents and transit times.

Methods: A randomised, placebo-controlled trial of linaclotide in pwCF. Linaclotide 290ug will be taken on the day before and on the MRI study day. Patients will then undergo serial MRI scanning for 6 hours following dosing at time T 0 , with a standard rice pudding meal at time T60 and a second 700kcal meal at T 300 minutes with the final scan at time T360minutes as the investigators have done previously. The investigators will measure small bowel water content (SBWC) as well as time for chyme to enter the colon (orocaecal transit time [OCTT]) and T1 ascending colon(T1AC), a measure of colonic water content. Primary endpoint: SBWC AUC 0-6hours . Secondary endpoints: change in SBWC after second meal from T300 to T360 ( ∆ SBWC), OCTT, T1 AC AUC 0-6 hours, bowel frequency and stool consistency on study day and the following 3 days.

Impact: If successful this will provide a mechanistic rationale for a full 12 week clinical study of linaclotide as adjunctive treatment for pwCF.

研究类型

介入性

注册 (估计的)

12

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

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

接受健康志愿者

不

描述

Inclusion Criteria:

  • • Participant is willing and able to give informed consent for participation in the study.

    • Proven diagnosis of CF.
    • Aged between 18-60 years.
    • Ability to conform to the study protocol, including overnight fasting, dietary and lifestyle restriction, administering linaclotide and placebo intervention, MRI scanning, consuming the two study meals and blue muffins, and rating stool frequency and appearance.

Exclusion Criteria:

  • Pregnant (current or planned during the study duration) or breastfeeding
  • Currently taking regular medicines (i.e., pain relief medication like ibuprofen/paracetamol) apart from cystic fibrosis medicines (i.e., pancreatic enzyme replacement therapy (PERT) medication, CFTR modulators). There are some other medicines it is OK to take such as:
  • Some antidepressants (SSRIs or low-dose tricyclics)
  • Antihistamines (for allergies)
  • The contraceptive pill
  • Any resections (surgery) of the intestines, not including removal of the appendix
  • Serious medical conditions including any other digestive disorder unrelated to CF.
  • Taken a course of intravenous or oral antibiotics in the last 2 weeks (except prophylactic antibiotics such as azithromycin).
  • Inability to stop opiates
  • Inability to have MRI scans (this could be due to some metallic implants, pacemaker, history of metallic foreign body in your eye and penetrating eye injury)
  • Night shift work during the week before study days
  • BMI under 18.5 or above 35 kg/m2.
  • Taken part in a CTIMP study in the last 4 weeks involving invasive procedures.
  • currently has chronic diarrhoea symptoms.

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：基础科学
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo
encapsulated lactose
药品：Placebo
lactose 20mg
有源比较器：linaclotide
linaclotide 290 ug over-encapsulated identical appearance to placebo
药品：Linaclotide 290 micrograms
linaclotide

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
Small Bowel Water Content AUC 0-6hours
大体时间：from enrolment until study end at approximately 4 weeks
Area under curve Small Bowel Water Content
from enrolment until study end at approximately 4 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in Small Bowel Water Content (SBWC)
大体时间：from enrolment until study end at approximately 4 weeks
change in SBWC after second meal from T300 to T360 ( ∆ SBWC),
from enrolment until study end at approximately 4 weeks
Orocaecal transit time (OCTT)
大体时间：from enrolment until study end at approximately 4 weeks
Time from meal ingestion to appearance of head of meal in caecum
from enrolment until study end at approximately 4 weeks
T1 ascending colon
大体时间：from enrolment until study end at approximately 4 weeks
T1 ascending colon(T1AC), a measure of colonic water content.
from enrolment until study end at approximately 4 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

University of Nottingham

合作者

Cystic Fibrosis Trust

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9月1日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年8月5日

首先提交符合 QC 标准的

2026年8月18日

首次发布 (实际的)

2026年8月21日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月18日

最后验证

2026年7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

  • FMHS 185-0526

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified information may be shared on request

IPD 共享时间框架

May 2027 for 7 years

IPD 共享访问标准

Access via principle investigator

IPD 共享支持信息类型

  • 研究方案
  • 企业社会责任

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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