ISRCTN70821789
Completed
未知
A double-blind, multicentre, randomized, parallel-group trial to compare efficacy and safety of GA-AT0719 versus simethicone in the treatment of functional abdominal bloating and distention
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Devintec Sagl
- Enrollment
- 88
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults between 18 and 65 years of age
- •2\. Caucasian race
- •3\. Suffering from functional abdominal bloating and distention
Exclusion Criteria
- •1\. Pregnant women or breastfeeding
- •2\. Unwilling to sign the informed consent form
- •3\. Allergy to one of the product ingredients
- •4\. Unable to come to the study visits
- •5\. Health status not allowing participation in the study
- •6\. Diabetic patients
- •7\. Patients diagnosed with celiac disease
- •8\. Patients treated with antibiotics 2 weeks prior to the Hydrogen Breath Test schedule
- •9\. Patients who were using purgatives within 2 weeks prior to the Hydrogen Breath Test
Outcomes
Primary Outcomes
Not specified
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