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Effect of Consumption of Dairy Product on Upper Gastric Discomfort

This study has been completed.
Sponsor:
Collaborator:
Hospital Italiano
Information provided by:
Danone Research
ClinicalTrials.gov Identifier:
NCT01422980
First received: April 21, 2011
Last updated: August 23, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Upper Gastric Discomfort
 Other: 1- Test dairy product containing specific ingredients
Other: 2- Control dairy product without specific ingredients

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
Official Title: Effect of Consumption of Dairy Product on Upper Gastric Discomfort

Further study details as provided by Danone Research:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: November 2010
Arms Assigned Interventions
Active Comparator: 1 = Test product
Arm 1 - intervention 1 (test product)
 Other: 1- Test dairy product containing specific ingredients
Placebo Comparator: 2 = Control product
Arm 2 - intervention 2 (control product)
 Other: 2- Control dairy product without specific ingredients

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422980

Locations
Argentina
Hospital Italiano
BuenosAires, Argentina, 1116
Sponsors and Collaborators
Danone Research
Hospital Italiano
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01422980     History of Changes
Other Study ID Numbers: NU345
Study First Received: April 21, 2011
Last Updated: August 23, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Danone Research:
dairy product
upper gastric discomfort
adult

ClinicalTrials.gov processed this record on May 23, 2013