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

NCT01291446 | Completed

• 1 other identifier: PR(AG)32/2010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Flatulence

Keywords

Intestinal gas production; Intestinal microbiota

Outcome Measures

Primary Outcomes (1)

• Intestinal gas evacuation

  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

  7 days

Secondary Outcomes (1)

• Colonic microbiota pattern

  7 days

Study Arms (1)

High flatulogenic diet

SHAM COMPARATOR

3-day diet containing fermentable residues

Dietary Supplement: High flatulogenic diet

Interventions

High flatulogenic diet DIETARY_SUPPLEMENT

During 3-days subjects will consume a diet with high content of fermentable residues

High flatulogenic diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Flatulence

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando Azpiroz, MD, PhD

  Vall d'Hebron University Hospital, Barcelona 08035, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 8, 2011
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 23, 2012

Record last verified: 2012-03

Locations

ES (1)