Effect of Consumption of Dairy Product on Upper Gastric Discomfort
Not Applicable
Completed
- Conditions
- Upper Gastric Discomfort
- Interventions
- Other: 1- Test dairy product containing specific ingredientsOther: 2- Control dairy product without specific ingredients
- Registration Number
- NCT01422980
- Lead Sponsor
- Danone Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 = Test product 1- Test dairy product containing specific ingredients Arm 1 - intervention 1 (test product) 2 = Control product 2- Control dairy product without specific ingredients Arm 2 - intervention 2 (control product)
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital Italiano
🇦🇷BuenosAires, Argentina