Trial to compare the efficacy and safety of GA-AT0719 versus simethicone in the treatment of excessive gas in the intestines (bloating)
| ISRCTN | ISRCTN70821789 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70821789 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | CEBNOV29072019 |
| Sponsor | Devintec Sagl |
| Funder | Devintec Sagl |
- Submission date
- 07/12/2020
- Registration date
- 09/12/2020
- Last edited
- 13/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Current plain English summary as of 06/04/2022:
Background and study aims
Functional gastrointestinal disorders (FGIDs) are a group of bowel disorders which are dominated by a feeling of abdominal fullness or bloating. Bloating is usually absent on awakening and worsens throughout the day. It may be intermittent and persists over several days. Bloating could arise without any predisposing factors and is unlikely to be completely resolved with medication and lifestyle modification.
Bloating is a common symptom that is reported by 6% to 31% of the general population. It is usually considered the sensation that is associated with abdominal distension (i.e. the visible increase in abdominal girth).
Simethicone is an inert substance with an antifoaming activity that reduces bloating, abdominal discomfort, and abdominal pain by promoting the clearance of excess gas along the gastrointestinal tract (digestive system).
One of possible reasons for bloating and distension is abnormal levels of bacteria in the small intestine, resulting in too much gas in the intestine. An imbalance of microorganisms that usually live in the bowel can sometimes be the result of antibiotic treatment. GA-AT0719 may reduce the interaction of microorganisms with the bowel, preventing the increase in gas content.
The aim of this study is to assess the effectiveness and safety of GA-AT0719 compared with simethicone in adult patients with abdominal bloating and distension.
Who can participate?
Caucasian adults aged between 18 and 65 with functional abdominal bloating and distention
What does the study involve?
Participants are randomly allocated to take GA-AT0719 or simethicone by mouth for 20 consecutive days.
What are the possible benefits and risks of participating?
This treatment could be very useful for the treatment of abdominal bloating and distention by reducing the associated symptoms. No adverse reactions to the study product have been reported.
Where is the study run from?
Devintec Sagl (Switzerland)
When is the study starting and how long is it expected to run for?
December 2019 to June 2020
Who is funding the study?
Devintec Sagl (Switzerland)
Who is the main contact?
Alina Iordache
alina.iordache@cebis-int.com
Previous plain English summary:
Background and study aims
Functional gastrointestinal disorders (FGIDs) are a group of bowel disorders which are dominated by a feeling of abdominal fullness or bloating. Bloating is usually absent on awakening and worsens throughout the day. It may be intermittent and persists over several days. Bloating could arise without any predisposing factors and is unlikely to be completely resolved with medication and lifestyle modification.
Bloating is a common symptom that is reported by 6% to 31% of the general population. It is usually considered the sensation that is associated with abdominal distension (i.e. the visible increase in abdominal girth).
Simethicone is an inert substance with an antifoaming activity that reduces bloating, abdominal discomfort, and abdominal pain by promoting the clearance of excess gas along the gastrointestinal tract (digestive system).
One of possible reasons for bloating and distension is abnormal levels of bacteria in the small intestine, resulting in too much gas in the intestine. An imbalance of microorganisms that usually live in the bowel can sometimes be the result of antibiotic treatment. GA-AT0719 may reduce the interaction of microorganisms with the bowel, preventing the increase in gas content.
The aim of this study is to assess the effectiveness and safety of GA-AT0719 compared with simethicone in adult patients with abdominal bloating and distension.
Who can participate?
Caucasian adults aged between 18 and 65 with functional abdominal bloating and distention
What does the study involve?
Participants are randomly allocated to take GA-AT0719 or simethicone by mouth for 20 consecutive days. After completion of the 20-day treatment period, the participants will be followed-up for 10 days.
What are the possible benefits and risks of participating?
This treatment could be very useful for the treatment of abdominal bloating and distention by reducing the associated symptoms. No adverse reactions to the study product have been reported.
Where is the study run from?
Devintec Sagl (Switzerland)
When is the study starting and how long is it expected to run for?
December 2019 to June 2020
Who is funding the study?
Devintec Sagl (Switzerland)
Who is the main contact?
Alina Iordache
alina.iordache@cebis-int.com
Contact information
Scientific
222 Calea Plevnei 3rd Floor
Bucharest
060016
Romania
 ORCID ID |
0000-0002-5931-0463 |
|---|---|
| Phone | +40 737 640 721 |
| alina.iordache@cebis-int.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind parallel randomized multicentre study |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | ISRCTN70821789_PIS.pdf |
| Scientific title | 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 |
| Study acronym | CONFORT ST |
| Study objectives | This randomized, double-blind clinical study evaluates the efficacy and safety of GA-AT0719 vs simethicone in adult patients with bloating and distension in functional gastrointestinal disorders (FGIDs). |
| Ethics approval(s) | 1. Approved 17/12/2019, National Committee of Bioethics of Medicines and Medical Devices (Stefan Cel Mare 19-21 Road, District 2, Bucharest, Romania; +40 (0)212102880; no email provided), ref: 2DM 2. Approved 27/12/2019, Ethics Committee for Clinical Trials (8 Damyan Gruev Str., Sofia 1303, Bulgaria; +359 (0)2 8903555; bda@bda.bg), ref: ЕККИ/CT-1234/27-12-2019 |
| Health condition(s) or problem(s) studied | Functional abdominal bloating and distention |
| Intervention | 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 consecutively. At the baseline visit (V1) participants perform the Hydrogen Breath Test (HBT) to confirm Small Intestinal Bacterial Overgrowth (SIBO). Glucose digestion is measured from hydrogen production using HBT measurements over 2 hours following glucose challenge. The Likert scale was used to measure the abdominal girth at every visit at the doctor’s office. The participants are re-evaluated using the Hydrogen Breath Test at day 20 (V4). HBT is performed under fasting conditions and after ingesting 50 g of glucose dissolved in 250 ml of water. Over a 2-hour period, breath samples are collected at 30-min intervals (e.g., from 8 am until 10 am). A positive HBT is defined as a hydrogen gas elevation of 12 parts per million (ppm) at two timepoints within the 30 min in 2 hours following a glucose-loading dose (ideally for two consecutive measurements). Participants' visits: 1. Baseline visit 2. Day 2 of treatment 3. Day 10 of treatment 4. Day 20 of treatment Previous intervention: 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 consecutively. At the baseline visit (V1) participants perform the Hydrogen Breath Test (HBT) to confirm Small Intestinal Bacterial Overgrowth (SIBO). Glucose digestion is measured from hydrogen production using HBT measurements over 2 hours. FAB symptoms are measured by the subject’s self-assessment of symptoms, bloating, distension, and abdominal pain by Likert scale following the glucose challenge test and measuring abdominal girth at every visit to the doctor’s office. The participants are re-evaluated using the Hydrogen Breath Test at day 20 (V4). HBT is performed under fasting conditions and after ingesting 50 g of glucose dissolved in 250 ml of water. Over a 2-hour period, breath samples are collected at 30-min intervals (e.g., from 8 am until 10 am). A positive HBT is defined as a hydrogen gas elevation of 12 parts per million (ppm) at two timepoints within the 30 min in 2 hours following a glucose-loading dose (ideally for two consecutive measurements). After completion of the 20-day treatment period, the participants will be followed-up for 10 days. Participants attend five visits: 1. Baseline visit 2. Day 2 of treatment 3. Day 10 of treatment 4. Day 20 of treatment 5. Day 30, 10 days after visit 4 |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | GA-AT0719, simethicone |
| Primary outcome measure(s) |
Current primary outcome measure as of 08/04/2022: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 06/04/2022: |
| Completion date | 30/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 88 |
| Total final enrolment | 88 |
| Key inclusion criteria | 1. Adults between 18 and 65 years of age 2. Caucasian race 3. Suffering from functional abdominal bloating and distention |
| Key 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 |
| Date of first enrolment | 16/01/2020 |
| Date of final enrolment | 20/05/2020 |
Locations
Countries of recruitment
- Bulgaria
- Romania
Study participating centres
8 Akademic Stefan Mladenov Street
Sofia
1700
Bulgaria
23 Petko D. Petkov Str
Plovdiv
4000
Bulgaria
25 Olimpi Panov Str., fl. 2
Ruse
7000
Bulgaria
5 Olimpiadei Street
Oradea
410151
Romania
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The data will be collected under the study confidentiality and for the study purpose only, according to the approved informed consent form. The study data will be archived according to the sponsor requirements and local regulatory requirements. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/11/2023 | 13/02/2025 | Yes | No | |
| Participant information sheet | 04/01/2021 | No | Yes | ||
| Participant information sheet | 04/01/2021 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN70821789_PIS.pdf
- Uploaded 04/01/2021
- ISRCTN70821789_PIS2.pdf
- Uploaded 04/01/2021
Editorial Notes
13/02/2025: Publication reference added.
08/04/2022: The primary outcome measure has been updated.
06/04/2022: The following changes have been made:
1. The intervention has been updated.
2. The primary outcome measure has been updated.
3. The secondary outcome measures have been updated.
4. The plain English summary has been updated.
04/01/2021: The participant information sheet has been uploaded.
08/12/2020: Trial's existence confirmed by the National Committee of Bioethics of Medicines and Medical Devices.
