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临床试验/NCT01776853
NCT01776853已完成不适用

Fructose and Fructans and Irritable Bowel Syndrome: MRI Study of Underlying Mechanisms

University of Nottingham2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
2
主要终点
Symptom response (yes/no)

研究概览

简要总结

The purpose of the study is to investigate if patients with Irritable Bowel Syndrome (IBS) who also report bloating are more likely to report clinically important gastrointestinal symptoms after consuming fructose or fructans than after consuming glucose. We will also use MRI imaging to investigate the mechanisms by which those symptoms might be caused.

We will also study a parallel group of age and gender frequency matched healthy volunteers to provide descriptive statistics on a likely reference range for the healthy population.

Irritable Bowel Syndrome (IBS) is a common chronic condition, the main features of which are pain in the abdomen, an erratic bowel habit and sometimes bloating. Recent research has found that certain carbohydrates (sugars) in the diet can cause symptoms such as discomfort, bloating and wind/gas in people with IBS. These sugars are not well digested in the small bowel. They move to the colon (large bowel) where bacteria act on them by fermentation, producing gas. Some of the gas is absorbed and breathed out through the lungs, where we can measure it. The rest is released as flatulence/ wind, or occasionally belching. People without IBS rarely get symptoms after consuming these sugars. We want to find out what is different in IBS sufferers.

We will study fructose and fructans, sugars found in fruit, vegetables and wheat. Fructose draws water into the small bowel but fructans do not so we can compare effects on the small bowel and colon. Participants will attend three times, and on each occasion consume a drink containing either fructose, fructans, or glucose - a sugar that does not cause symptoms. Neither they nor the investigators present will know which drink is which. They will record their symptoms over the next 5 hours. We will observe how many report a clinically important increase in symptoms.

To look at what is happening in the bowel we will use a technique called Magnetic Resonance Imaging (MRI). We want to see if more gas, or water, builds up in people with IBS than in healthy volunteers. We will also measure the amount of hydrogen released in the breath to see if this is could be a simple bedside test that agrees with the MRI findings

Finding differences between the response of participants to fructose, fructans and glucose could change the way we advise patients, and could lead to the use of MRI as a test for IBS.

详细描述

PURPOSE

  1. To investigate if patients with Irritable Bowel Syndrome (IBS) who also report bloating are more likely to report clinically important gastrointestinal symptoms following ingestion of fructose or fructans compared to glucose.
  2. To investigate the mechanisms by which those symptoms might be caused.

There will be a parallel pilot study of age and gender frequency matched healthy volunteers (HV).

HYPOTHESES

  1. Patients with IBS will report more symptoms after ingestion of either fructose or fructans compared to an equal mass of glucose.
  2. Fructans and fructose will each cause greater H2 excretion and greater volume of gas in the colon (CGV) than glucose.
  3. Fructose will cause greater increase in small bowel fluid volume/ water content (SBWC) than glucose or fructans.
  4. Greater CGV will provoke more and/or more intense symptoms
  5. Greater SBWC will provoke more and/or more intense symptoms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who meet the Rome III research diagnostic criteria for IBS(Longstreth 2006) who also report bloating OR
  • Healthy volunteers who do not meet Rome III clinical diagnostic criteria for IBS
  • Aged 18-65
  • Able to give informed consent

排除标准

  • Any reported history of gastrointestinal surgery (excluding appendicectomy or cholecystectomy)
  • Presence of an intestinal stoma
  • Pregnancy declared by candidate
  • Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
  • Reported alcohol dependence
  • Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test. (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
  • Antibiotic or probiotic treatment in the past 4 weeks
  • Inability to lie flat or exceed scanner limits of weight <120kg
  • Poor understanding of English language
  • Participation of any medical trials for the past 3 months
  • Judgement by the PI that the candidate who will be unable to comply with the full study protocol e.g. Diabetes, severe Chronic Obstructive Pulmonary Disease(COPD)

结局指标

主要结局

Symptom response (yes/no)

时间窗: At any point 0-5 hours after exposure

Clinically important GI symptoms (yes/no) reported by participants in the 5 hours after exposure. * We will measure 4 symptoms from a previously validated questionnaire (Suarez 1995) on a scale of 0 (none), 1 (mild/ distinct but negligible), 2 (moderate/ annoying), 3 (severe/ disabling) * Symptoms include abdominal pain, bloating, gas/flatulence, and diarrhoea. * We will add together scores for each symptom to get the total score (min 0; max 12) * We will define clinically important symptoms as an increase from baseline in additive total score of 3 or greater.

次要结局

  • Colonic Gas Volume(0-5 hours after intervention)
  • Symptom Intensity(0-5 hours after intervention)
  • Breath Hydrogen(0-5 hours after intervention)
  • Small Bowel Water Content(0-5 hours after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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