Functional abdominal bloating and distention Digestive System
Conditions
Interventions
Current intervention as of 06/04/2022:
Participants are randomized in a 1:1 ratio to GA-AT0719 or simethicone. Both products are administered three times per day by oral route for 20 days consecutivel
Sponsors
Devintec Sagl
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 08/04/2022: 1. Occurrence of adverse events: frequency, intensity and relation with the administered treatments measured using case report forms during the study period 2. Clinical parameters monitored and vital signs examined between pre- and post-study visits: 2.1. Physical examination (height, weight, blood pressure, temperature, BMI) at Day 0 and Day 20 2.2. Safety assessed using patient’s report at Day 0, Day 2, Day 10, and Day 20 Previous primary outcome measure as of 06/04/2022: 1. Occurrence of adverse events: frequency, intensity and relation with the administered treatments measured using case report forms during the study period 2. Clinical parameters monitored and vital signs examined between pre- and post-study visits: 2.1. Physical examination (height, weight, blood pressure, temperature, BMI) at Day 0 and Day 20 2.2. Safety assessed using patient’s report at Day 0, Day 2, Day 10, Day 20 and Day 30 Previous primary outcome measure: 1. Occurrence of adverse events: frequency, intensity and relation with the administered treatments measured using case report forms during the study period 2. Clinical parameters monitored and vital signs examined between pre- and post-study visits: 2.1. Physical examination (height, weight, blood pressure, temperature, BMI) at Day 0, Day 20 and Day 30 2.2. Evaluation of stool based on Bristol scale at Day 0, Day 2, Day 10, Day 20 and Day 30 2.3. Safety assessed using patient’s report at Day 0, Day 2, Day 10, Day 20 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 06/04/2022: 1. Symptomatology of bloating and distention in FGIDs 2. Onset of effectiveness: time to onset of symptoms improvement assessed with visual analogue scale (VAS) before, at 60 and 120 min after the dose of the first 8 days of therapy 3. Symptomatology of bloating and distention in FGIDs, possibly caused by SIBO assessed using a Hydrogen Breath Test at Day 1 (V1) and Day 20 (V4) Previous secondary outcome measures: 1. Symptomatology of bloating and distention in FGIDs assessed using the Likert gastrointestinal symptom score (GIS) scale using a daily journal kept for the entire period of the study treatment and throughout the 10-day follow-up period and by measuring abdominal girth at every visit to the doctor’s office 2. Onset of effectiveness: time to onset of symptoms improvement assessed with visual analogue scale (VAS) before, at 60 and 120 min after the dose of the first 8 days of therapy 3. Symptomatology of bloating and distention in FGIDs assessed using a Hydrogen Breath Test at Day 1 (V1) and Day 20 (V4) | — |
Countries
Bulgaria, Romania
Outcome results
None listed