Effect of Diet on Intestinal Gas Production and Evacuation in Healthy Subjects and Flatulent Patients
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.
- 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.
|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|
- 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
- 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
|Study Start Date:||November 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01291446
|University Hospital Vall d'Hebron|
|Barcelona, Spain, 08035|
|Principal Investigator:||Fernando Azpiroz, MD, PhD||Vall d'Hebron University Hospital, Barcelona 08035, Spain|