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OpenTrials
Completed

NCT Number: NCT01422980

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.

Completed

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Key information

Conditions

Upper Gastric Discomfort

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Italiano

Buenos Aires, 1116, Argentina

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1- Test dairy product containing specific ingredients

Other

2- Control dairy product without specific ingredients

Other

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 25, 2011
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.