Effect of Diet on Intestinal Gas Production and Evacuation in Healthy Subjects and Flatulent Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01291446
First received: February 7, 2011
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Flatulence
Dietary Supplement: High flatulogenic diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Objective Markers Flatulence: Determination of Gas Production and Evacuation in Response to Dietary Manipulations

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Intestinal gas evacuation [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Colonic microbiota pattern [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Colonic microbiota pattern will be measured during a 3-day basal phase on their current diet and a 3-day challenge phase on a high flatulogenic diet


Enrollment: 50
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: High flatulogenic diet
3-day diet containing fermentable residues
Dietary Supplement: High flatulogenic diet
During 3-days subjects will consume a diet with high content of fermentable residues
Other Name: High flatulogenic diet

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291446

Locations
Spain
University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: Fernando Azpiroz, MD, PhD Vall d'Hebron University Hospital, Barcelona 08035, Spain
  More Information

No publications provided

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01291446     History of Changes
Other Study ID Numbers: PR(AG)32/2010
Study First Received: February 7, 2011
Last Updated: March 22, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Intestinal gas production
Intestinal microbiota

Additional relevant MeSH terms:
Flatulence
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014