Upper Gastric Discomfort Clinical Trial
Official title:
Effect of Consumption of Dairy Product on Upper Gastric Discomfort
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.
| Status | Completed |
| Enrollment | 236 |
| Est. completion date | July 2011 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 21 Years to 60 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Italiano | BuenosAires |
| Lead Sponsor | Collaborator |
|---|---|
| Danone Research |
Argentina,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |