Trial to compare the efficacy and safety of GA-AT0719 versus simethicone in the treatment of excessive gas in the intestines (bloating)

Not Applicable

Completed

• Conditions: Functional abdominal bloating and distention; Digestive System

• Registration Number: ISRCTN70821789
• Lead Sponsor: Devintec Sagl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-06-30
• Study Start: 2020-12-09
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified