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临床试验/NCT01291446
NCT01291446已完成不适用

Objective Markers Flatulence: Determination of Gas Production and Evacuation in Response to Dietary Manipulations

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Intestinal gas evacuation

研究概览

简要总结

Background Some patients complain of excessive evacuation, which may become socially disabling (Azpiroz F & Malagelada J-R, 2005). However, there no systematic investigation on the range of gas evacuation in healthy subjects and in subjects complaining of flatulence under basal conditions and in response to a high-flatulogenic diet (Azpiroz F & Levitt DG, 2009).

Hypothesis Patients complaining of excessive passage of gas per anus have more intestinal gas production and more anal gas evacuation during basal conditions and in response to a high flatulogenic diet than healthy subjects. This abnormality is related to the differences in colonic microflora.

Objectives

  • To determine the normal range of intestinal gas evacuation under basal conditions and in response to a high flatulogenic diet.
  • In patients complaining of flatulence, to determine whether intestinal gas evacuation under basal conditions and in response to a high flatulogenic diet is increased.
  • To identify differences in the microbiota pattern in subjects with normal and excessive anal gas evacuation.
  • In patients complaining of flatulence, to determine the segmental distribution of intestinal gas after a diet challenge.

Methods Healthy subjects (n=20) and patients complaining of flatulence (n=30) will undergo a 3-day basal phase on their current diet and a 3-day challenge phase on a high-flatulogenic diet; patients will be followed-up for 7 days on a low-flatulogenic diet. The following g measurements will be performed: daily measurement of the number of anal gas passages with an event marker, continuous recording of anal gas evacuation in the laboratory using an electronic leakage-free gas collection system, colonic flora analysis by fecal sampling, and segmental gas distribution in the gut by abdominal computer tomography (CT) imaging.

Relevance These studies will allow to develop the normal range of anal gas evacuation during basal conditions. Furthermore, a provocative test will be developed for the diagnosis of excessive gas production in patients complaining of flatulence. This data will allow a proper diagnosis of these patients and will pave the path for a rational management and for the development of evidence-based treatment strategies. This pilot study will allow a proper design with adequate sample size calculation in future interventional studies.

详细描述

Background Some patients complain of excessive evacuation, which may become socially disabling (Azpiroz F & Malagelada J-R, 2005). However, the physiology and pathophysiology of flatulence remains poorly understood (Azpiroz F & Levitt DG, 2009).

Gas evacuated by anus originates by-and-large in the colon, where unabsorbed meal residues are fermented by colonic bacteria (Anderson et al., 1981;Levitt et al., 1987;Flourie et al., 1988). Indeed, it has been shown that some food components are incompletely absorbed in the small bowel and enter the colon (Wolever & Robb, 1992;Grimble, 1989;Steggerda FR, 1968;Wagner et al., 1977;Steggerda F.R. & Dimmick, 1966;Stone-Dorshow & Levitt, 1987;Wursch et al., 1989) and that other intraluminal substrates interfere with the absorption of nutrients (Boibin M et al., 1998;Hamberg et al., 1989;Brugge & Rosenfeld, 1987;Taylor et al., 1986;Layer et al., 1986). Hence, the volume of gas production and anal evacuation is determined by two main factors: the diet, particularly the amount of fermentable residues, and the individual composition of colonic microflora. Within subjects, gas output varies in relation to the diet (Steggerda FR, 1968;Kirk, 1949). However, there is a great interindividual variability, and gas evacuation in subjects maintained on a similar diet may differ substantially.

It has been shown that healthy subjects on a normal diet containing 200 g of beans evacuate 705 mL gas per 24 hours, whereas with a fiber the diet gas evacuation was 214 mL (Tomlin et al., 1991). In healthy subjects the frequency of gas evacuation is variable, usually around 10 evacuation per day (Furne & Levitt, 1996). Based on observations on a patient that who passed large amounts of flatus, a classification of foodstuffs depending on their gas producing capacity was elaborated (Sutalf LO & Levitt MD, 1979). Few studies on specific foodstuffs have been later added to complement this information (Wolever & Robb, 1992;Wagner et al., 1977;Hickey C et al., 1972). However, there no systematic investigation on the range of gas evacuation in healthy subjects and in subjects complaining of flatulence under basal conditions and in response to a high-flatulogenic diet.

Procedures Recruitment questionnaire A questionnaire will be used to evaluate gas evacuation, bowel habit and functional gut symptoms.

Daily measurement of the number of anal gas evacuations and symptoms The number of gas evacuations per anus will be measured using an event marker during daytime. At the end of the day the following parameters will be recorded on a questionnaire: discomfort related to flatulence and evaluation of abdominal discomfort/pain (using 0-10 analogue scales); the number of bowel movements and form (using the Bristol scale; (Heaton & O'Donnell, 1994) and gastrointestinal well-being (satisfaction/dissatisfaction using a 10 point scale graded from +5 to -5).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Screening
盲法
None

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
是

入选标准

  • •Women and men between the ages of 18 and 70 years.
  • •Excessive gas evacuation will be checked at the first visit with a questionnaire "do you pass too much gas per anus, i.e., a lot of a passages along the day ?"
  • •Subjects of normal body weight or with overweight ie not obese (body mass index between 18 and 30 kg/m2, bounds included )
  • •Subject willing to maintain their current diet without significant changes (ie. new caloric restriction or elimination diet) for the duration of the study
  • •Subjects who provide written informed consent before participating in the study after being given a full description of the study

排除标准

  • •Subjects with abnormal finding of vital signs at the screening examination which would interfere with the objectives of the study
  • •Subjects with a history of clinical significant hepatic, renal, respiratory, psychiatric, neurological, endocrine, infectious, cardiovascular, pulmonary, haematological or systemic disorders.
  • •Antecedents of abdominal surgery, excluding appendicectomy or hernia
  • •Subjects who are already taking or have taken in the past 2 months any investigational drug
  • •Use of antibiotics in the month preceding the inclusion visit.
  • •Current use of any medications with potential central nervous system effects as judged by the investigator (including but not limited to antidepressants, anxiolytics, opiate pain medications)
  • •Taking drugs that might modify gastrointestinal function
  • •Taking antibiotics within 60 days prior to entry into the study.
  • •Subjects with a history of drug, alcohol or other substance abuse (including caffeine and tobacco), or other factors limiting their ability to co-operate during the study.
  • •Subjects not willing or not available to attend all the test-days and investigations as foreseen by the protocol.
  • •Subjects not collaborating, unable to understand the aim, the procedure or the possible hazards of the study.
  • •Patient with allergy or hypersensitivity to food proposed during the food challenge

研究组 & 干预措施

High flatulogenic diet

Sham Comparator

3-day diet containing fermentable residues

干预措施: High flatulogenic diet (Dietary Supplement)

结局指标

主要结局

Intestinal gas evacuation

时间窗: 7 days

Intestinal gas evacuation will be measured during a 3-day basal phase on their current diet and a 3-day challenge phase on a high flatulogenic diet

次要结局

  • Colonic microbiota pattern(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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