The effect of a probiotic compound in dyspeptic patients [Eficácia terapêutica de composto probiótico em pacientes dispépticos]

ISRCTN	ISRCTN22923997
DOI	https://doi.org/10.1186/ISRCTN22923997
Secondary identifying numbers	N/A

Submission date: 28/12/2011
Registration date: 31/01/2012
Last edited: 26/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Ricardo Barbuti
Scientific

Eneas Carvalho de Aguiar, 255
Department of Gastroenterology
Instituto Central do Hospital das Clínicas (ICHC)
Sao Paulo
05403-000
Brazil

Email	rbarbuti@terra.com.br

Study information

Study design	Prospective randomized double-blind placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Therapeutic efficacy of a probiotic compaond in dyspeptic patients: a randomised controlled trial
Study objectives	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(s)	Universiy of São Paulo Ethics Commitee, 31/08/2011
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/01/2012
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	150
Key inclusion criteria	1. Must have diagnosis of functional dyspepsia (Rome III criteria) 2. Signed informed consent 3. Aged between 18 and 80
Key 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
Date of first enrolment	15/01/2012
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Brazil

Study participating centre

Instituto Central do Hospital das Clínicas (ICHC)

Sao Paulo
05403-000
Brazil

Sponsor information

Brazil Foods (Brazil)
Industry

Rua Hungria
1.400 - Edifício Quadra
Jardim Europa
São Paulo
01455-000
Brazil

Email	susana.santos@brasilfoods.com
Website	http://www.brasilfoods.com/
"ROR"	https://ror.org/05xv38e59

Funders

Funder type

Industry

Brazil Foods (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

26/05/2017: Plain English summary added.