Upper Gastric Discomfort
Conditions
Keywords
dairy product, upper gastric discomfort, adult
Brief summary
The purpose of this study is to determine whether the consumption of test dairy products is effective in reducing upper gastric discomfort after 2 weeks of product consumption.
Interventions
OTHER1- Test dairy product containing specific ingredients
OTHER2- Control dairy product without specific ingredients
Sponsors
Danone Global Research & Innovation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female * 21 - 60 years old * Experiencing upper gastric discomfort
Exclusion criteria
* Participants with alarm symptoms (dysphagia, bleeding, involuntary weight loss clinically significant \>10% of it habitual weight during the last 6 months). * Participants with diagnosed severe organic esophageal medical history (endoscopic eosophagitis A, B, C or D of Los Angeles classification, peptic stenosis, Barrett oesophagus, huge hiatus hernia or para-esophageal) gastric or duodenal ulcer or high digestive haemorrhage clinical history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in gastro-oesophageal symptoms as assessed by RDQ questionnaire | Two timepoints are considered in the assessment of the change outcome measures: from Baseline (before product consumption) to Endpoint (i.e. final evaluation visit after 2 weeks of product consumption) |
Countries
Argentina
Outcome results
None listed