Effect of Consumption of Dairy Product on Upper Gastric Discomfort

Danone Global Research & Innovation Center236 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

236

Conditions

Upper Gastric Discomfort

Interventions

1- Test dairy product containing specific ingredientsOTHER

2- Control dairy product without specific ingredientsOTHER

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Italiano

Buenos Aires, Argentina

Outcomes

Primary Outcomes

Change in gastro-oesophageal symptoms as assessed by RDQ questionnaire

Time frame: 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)

Data from ClinicalTrials.gov

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