Condition category
Digestive System
Date applied
28/12/2011
Date assigned
31/01/2012
Last edited
26/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.brasilfoods.com/

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

Publication citations

Additional files

Editorial Notes

26/05/2017: Plain English summary added.