Effect of Consumption of Dairy Product on Upper Gastric Discomfort

Danone

Status: Completed

Conditions: Upper Gastric Discomfort

Treatments: Other: 1- Test dairy product containing specific ingredients; Other: 2- Control dairy product without specific ingredients

Study type: Interventional

Funder types: Industry

Identifiers

NCT01422980

NU345

Details and patient eligibility

About

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.

Enrollment: 236 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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236 participants in 2 patient groups, including a placebo group

1 = Test product

Active Comparator group

Description:

Arm 1 - intervention 1 (test product)

Treatment:

Other: 1- Test dairy product containing specific ingredients

2 = Control product

Placebo Comparator group

Description:

Arm 2 - intervention 2 (control product)

Treatment:

Other: 2- Control dairy product without specific ingredients