|
ISRCTN
|
ISRCTN22923997
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The effect of a probiotic compound in dyspeptic patients [Eficácia terapêutica de composto probiótico em pacientes dispépticos]
|
|
Scientific title
|
Therapeutic efficacy of a probiotic compaond in dyspeptic patients: a randomised controlled trial
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Functional dyespesia 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.
|
|
Lay summary
|
Lay summary under review 3
|
|
Ethics approval
|
Universiy of São Paulo Ethics Commitee, 31 August 2011
|
|
Study design
|
Prospective randomized double-blind placebo controlled study
|
|
Countries of recruitment
|
Brazil
|
|
Disease/condition/study domain
|
Functional dyespesia
|
|
Participants - inclusion criteria
|
1. Must have diagnosis of functional dyspepsia (Rome III criteria)
2. Signed informed consent
3. Aged between 18 and 80
|
|
Participants - 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
|
|
Anticipated start date
|
15/01/2012
|
|
Anticipated end date
|
31/12/2012
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
150
|
|
Interventions
|
150 patients with functional dyspepsia will be divided in 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.
|
|
Primary outcome measure(s)
|
1. The Short-Form Leeds Dyspepsia Questionnaire
2. Biochemestry of ghrelin and leptin levels
|
|
Secondary outcome measure(s)
|
1. Adverse events
2. Compliance
3. Bowel habit
4. Body Mass Index (BMI)
|
|
Sources of funding
|
Brazil Foods (Brazil)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Ricardo
Barbuti
|
|
Address
|
Eneas Carvalho de Aguiar, 255
Department of Gastroenterology
Instituto Central do Hospital das Clínicas (ICHC)
|
|
City/town
|
Sao Paulo
|
|
Zip/Postcode
|
05403-000
|
|
Country
|
Brazil
|
|
Email
|
rbarbuti@terra.com.br
|
|
Sponsor
|
Brazil Foods (Brazil)
|
|
Address
|
Rua Hungria
1.400 - Edifício Quadra
Jardim Europa
|
|
City/town
|
São Paulo
|
|
Zip/Postcode
|
01455-000
|
|
Country
|
Brazil
|
|
Email
|
susana.santos@brasilfoods.com
|
|
Sponsor website:
|
http://www.brasilfoods.com/
|
|
Date applied
|
28/12/2011
|
|
Last edited
|
31/01/2012
|
|
Date ISRCTN assigned
|
31/01/2012
|
