A Pilot Double Blind, Randomised, Placebo Controlled Trial of the Effect of a Diet Low in Poorly Digested Carbohydrates on Symptoms of Post-infective Bowel Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Moderate or substantial improvement in irritable bowel syndrome (IBS) symptoms on IBS-GIS
研究概览
简要总结
The purpose of the study is explore the issues that relate to testing a particular dietary treatment, the low FODMAP diet, in a randomised trial using an appropriate control diet with which to compare it. In this trial the investigators will look at its effect on symptoms of people with persistent disturbance in their bowel pattern 3 months after an intestinal infection with Campylobacter.
The investigators will also look at the changes in gut bacteria that occur with the diet.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the CERAMIC study (see linked protocol)
- •On-going post infective bowel dysfunction (PI-BD) 3 months after confirmation of Campylobacter spp. in stool sample. This is defined as responding 'No' to the question "have your bowels returned to normal since your Campylobacter infection?"
- •Will consent to use of data and samples acquired for CERAMIC in the analysis of CEDRIC
排除标准
- •As for CERAMIC study (so already confirmed)
- •Pregnancy declared by the candidate
- •History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to: Inflammatory Bowel Disease; Coeliac Disease; Pancreatitis; Gallstone disease (biliary colic, cholecystitis); Diverticulitis; Cancer of the gastrointestinal tract; Irritable Bowel Syndrome
- •Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder
- •Intestinal stoma
- •Habitual use of opiate analgesics likely to alter bowel function e.g. morphine
- •Use of antibiotics in the preceding four weeks other than for treatment of index infection. Any condition where the candidate is likely to require a course of antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent urinary tract infection, lower limb ulceration
- •Inability to complete the symptom questionnaires e.g. cognitive dysfunction, limiting memory and understanding
- •Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse
- •Addition criteria for CEDRIC study:
- •Use of antibiotics or prescribed probiotics during the CERAMIC study
- •Failure to provide research stool samples during CERAMIC study
- •Dietary practice not compatible with safe implementation of the trial diet e.g.veganism
- •Medical reasons for pre-existing controlled diet that cannot be safely randomised e.g. end-stage kidney disease, diabetes
结局指标
主要结局
Moderate or substantial improvement in irritable bowel syndrome (IBS) symptoms on IBS-GIS
时间窗: 1 month after start of diet
The IBS-GIS (Irritable Bowel Syndrome Global Improvement Score) is a validated 7-point balance scale to assess change in perception of symptoms in functional bowel disorders. Points 6 and 7 on the scale refer to moderate or substantial improvement. The outcome measure will be the proportion of participants in each group marking point 6 or 7 on the balance scale at this time point.
次要结局
- Moderate or substantial improvement in IBS symptoms(6 months after star of diet)
- Adequate control of IBS symptoms(6 months after start of diet)
- Percentage of days with loose stool(during last 14 days of dietary intervention)
- Change from baseline in IBSS(6 months after start of diet)
- Change from baseline in fasting colonic volume(1 month after start of diet)
- Change in fasting colonic gas volume(1 month after start of diet)
- Change from baseline in stool concentration of Bifidobacteria(6 months after start of diet)