Plain English Summary
Background and study aims
Functional dyspepsia is a condition that causes an upset stomach or pain or discomfort in the upper belly, near the ribs. Probiotics are live bacteria and yeasts promoted as having various health benefits, which can taken as food supplements. The aim of this study is to assess the effects of a probiotic in patients with functional dyspepsia.
Who can participate?
Patients aged between 18 and 80 with functional dyspepsia
What does the study involve?
Participants are randomly allocated to take either a probiotic, a probiotic with a lipidic (fat) emulsion (Fabuless), or a placebo (dummy supplement). Blood samples are collected and functional dyspepsia symptoms are assessed in all three groups.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Instituto Central do Hospital das Clínicas (ICHC) (Brazil)
When is the study starting and how long is it expected to run for?
January 2012 to December 2012
Who is funding the study?
Brazil Foods (Brazil)
Who is the main contact?
Dr Ricardo Barbuti
rbarbuti@terra.com.br
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ricardo Barbuti
ORCID ID
Contact details
Eneas Carvalho de Aguiar
255
Department of Gastroenterology
Instituto Central do Hospital das Clínicas (ICHC)
Sao Paulo
05403-000
Brazil
-
rbarbuti@terra.com.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Therapeutic efficacy of a probiotic compaond in dyspeptic patients: a randomised controlled trial
Acronym
Study hypothesis
Functional dyspesia is the most common functional disease of the upper gastrointestinal (GI) tract, its prevalence is around 20-40% in the eastern population of Brazil. Functional dyspepsia is a disease whose physiopathology is dependent of gastric motiliy as well as gut microbiota. Probiotics can interfere wiith both. The chronic use of such supplements can improve dyspepsia.
Ethics approval
Universiy of São Paulo Ethics Commitee, 31/08/2011
Study design
Prospective randomized double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Functional dyespesia
Intervention
150 patients with functional dyspepsia will be divided into three groups:
1. Probiotic
2. Probiotic + lipid
3. Placebo
They will receive the products for 3 months, symptoms and biochemistry will be achieved before the study, in the end of the products supplementation and 3 months after stopping the products.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. The Short-Form Leeds Dyspepsia Questionnaire
2. Biochemistry of ghrelin and leptin levels
Secondary outcome measures
1. Adverse events
2. Compliance
3. Bowel habit
4. Body Mass Index (BMI)
Overall trial start date
15/01/2012
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Must have diagnosis of functional dyspepsia (Rome III criteria)
2. Signed informed consent
3. Aged between 18 and 80
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Abdominal surgery
2. Major commorbidities that lead to use of drugs which can interfere with symptoms or modify gastric or bowel motility
3. Gastroesophageal reflux disease (GERD)
4. Active peptic ulcer disease (PUD)
5. Use of non steroidal anti inflammatory drugs (NSAIDs) or antibiotics
6. Gastrointestinal (GI) tract neoplasia
7. Pregnant women
8. History of yogurt intolerance or allergy
Recruitment start date
15/01/2012
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Brazil
Trial participating centre
Instituto Central do Hospital das Clínicas (ICHC)
Sao Paulo
05403-000
Brazil
Sponsor information
Organisation
Brazil Foods (Brazil)
Sponsor details
Rua Hungria
1.400 - Edifício Quadra
Jardim Europa
São Paulo
01455-000
Brazil
-
susana.santos@brasilfoods.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Brazil Foods (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary