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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014