Irritable Bowel Syndrome With Constipation (IBS-C)RELAXNCT05240521
Efficacy and Safety, Tolerability of GA-AT0119 in IBS-C
A study testing ARM A and ARM B in people with Irritable Bowel Syndrome With Constipation (IBS-C), run by Devintec Sagl at 4 sites in Bulgaria.
Trial summary
Irritable bowel syndrome (IBS) is a common functional bowel disorder that imposes a considerable burden on health-related quality of life (QOL) worldwide. Irritable Bowel Syndrome (IBS) is a common digestive disorder affecting 7-21% of the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation (IBS-C)
- What is being tested?
- ARM A and ARM B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesBulgaria
- Study dates
- 1 Nov 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects over 18 years old;
- Subject willing to sign the informed consent;
- The ability to comply with study visits;
- Patients with constipation following diagnostic of IBS-C (Subtypes prevalent presentation of stool in IBS according to the Rome IV Criteria: IBS with constipation (IBS-C) - ( >25% hard stools and <25% loose stools)
Who cannot join
- Use of gelatin tannate, diosmectite, probiotics, racecadotril or any other drugs or medical devices known to alter gastrointestinal motility or secretion within four weeks prior to enrolment
- Chronic diarrhea caused by cystic fibrosis, coeliac disease, food allergy, diabetes Chronic diarrhea caused by lactose, fructose, or sorbitol intolerance
- Diagnostic of IBS-D
- Use of prebiotics, fiber supplements, laxatives, 5-HT4 agonists, antispasmodic, antidepressants with 4 weeks prior study Baseline visit
- Immunodeficiencies
- Abnormal thyroid function, a history of alcohol abuse or binge drinking, pancreatitis, sphincter of Oddi dysfunction, cholecystitis within the past 6 months, or known allergy to any of the components of the product or placebo
Show all 9Show fewer
- The patient is a member of the investigational team or his/her immediate family
- Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study
- Hypersensitivity to any of the ingredients of the study agents
Trial locations and contacts
4 sites in 1 country.
Bulgaria4 sites, 3 recruiting
- Recruiting
Outpatient clinic for individual practice for primary medical care Dr. Elenski EOOD
Plovdiv
Mariya Armova, 00359884268270, mariyaarmova@gmail.com
- Recruiting
Medical Center Prolet EOOD
Rousse
Petar Yanev, 00359887842514, drpepi0110@gmail.com
- Active, not recruiting
Medical Center Prolet EOOD
Rousse
- Recruiting
Ambulatory Practice for Primary Outpatient Medical Care SANA OOD
Sofia
Zlatka Etropolska, 00359878510845, z.etropolska@medcogc.org
About this study
Official title: A Double-Blind, Placebo-Controlled, Crossover-Over Clinical Trial Investigating the Efficacy and Safety, Tolerability of GA-AT0119 in the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C)
Irritable bowel syndrome (IBS) is a common functional bowel disorder that imposes a considerable burden on health-related quality of life (QOL) worldwide. Irritable Bowel Syndrome (IBS) is a common digestive disorder affecting 7-21% of the general population. IBS with predominant constipation (IBS-C) is a subtype of IBS that accounts for more than a third of the IBS diagnosed.
The study Sponsor, Devintec SAGL, presents GA-AT0119, which acts by forming a mechanical barrier on the intestinal mucosa thanks to xyloglucan and pea proteins avoiding the increased intestinal permeability, bacterial invasion to intestinal tissues, and subsequent intestinal inflammation. The formulation of GA-AT0119 is completed with chia seed powder which provides a laxative effect by retaining water in the intestine increasing stool bulk and accelerating fecal transit.
There is increasing evidence that the pathophysiology of IBS is multifaceted involving mucosal inflammation, visceral hypersensitivity, microbial dysbiosis, dietary factors, and altered intestinal permeability (IP). Several studies have shown increased intestinal permeability in patients with irritable bowel syndrome. Serum zonulin, a biomarker of impaired increased permeability, is increased in patients' constipation-predominant irritable bowel syndrome compared to a healthy population and the levels are comparable to celiac disease.
Read the detailed description
Each subject will be asked to sign the Informed Consent Form (ICF). The patients diagnosed with IBS-C will be randomized in 1:1 ratio. The treatment will be administrated according to the approved leaflet and study procedures. Eligible patients will be randomized to receive either GA-AT0119 or Placebo. Patients will be treated according to the approved leaflet. The study subjects will return at day 7, 15 and day 28 for evaluation. Each subject will undergo a washout period of 28 days. At Day 56 each subject will be evaluated and will receive the crossover therapy line and start administration. Subject will be evaluated at Day 84 at the end of the crossover period. Patients will be evaluated for constipation symptoms, global assessment for tolerability, safety. Each subject will receive a diary where bowel frequency, type and transit time will be completed during product administration. From visit 2 to visit 6, patients will be evaluated for treatment adherence and clinical symptoms recurrences. Each subject will complete 2 additional phone follow-ups Visit for safety reporting and clinical symptoms recurrences according to protocol. During the follow-up visits subject will be evaluated also by using Likert scale for Abdominal Pain and discomfort, Sickness Impact Profile score, IBS-VAS scale and IBS-QoL.
- Being tested
- ARM A, ARM B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARM AOther
30 IBS-C patients will receive GA-AT0119 for 28 days, followed by a washout period of 28 days and Placebo for another 28 days
ARM BOther
30 IBS-C patients will receive Placebo for 28 days, followed by a washout period of 28 days and GA-AT0119 for another 28 days
| Study group | Role | What they receive |
|---|---|---|
| ARM A: GA-AT0119 / Placebo | Other | Cross-over Study Receives: Other: ARM A; Other: ARM B |
| ARM B: Placebo / GA-AT0119 | Other | Cross-over Study Receives: Other: ARM A; Other: ARM B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Subjective Symptom Improvement assessed through Likert scale (Discomfort, Bloating Abdominal Pain) at day 7, 15, 28, 56, 84,114,144
The clinical symptoms that are going to be assessed through the 7 point Likert Scale are: Bloating, Discomfort, abdominal pain.
Likert scale - level of acceptability:
- - Totally unacceptable
- - Unacceptable
- - Slightly unacceptable
- - Neutral
- - Slightly acceptable
- - Acceptable
- - Perfectly Acceptable
Measured: 144 days
Change from baseline in BMI assessed at Day 7,15, 28, 56,84
The BMI will be evaluated
Measured: 84 days
Change from baseline in stool consistency will be assessed at Day 0, 7, 15, 28, 56, 84, 114, 144, through the Bristol Stool Scale.
Type of stool will be assessed according to the Bristol Stool Chart ((Stool Type 1 - severe constipation, Stool Type 2 - mild constipation, Stool Type 3 - normal, Stool Type 4 - normal, Stool Type 5 - lacking fiber, Stool Type 6 - mild diarrhea, Stool Type 6 - severe diarrhea)
Measured: 144 days
Change from baseline score in IBS-QoL questionnaire (Information Sheet on the Irritable Bowel Syndrome - Quality of Life Measure) at Day 7, 15, Day 28 and Day 56, Day 84, Day 114, Day 144
Patients will respond to the IBS-QoL questionnaire. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.
Measured: 144 days
Change of Sickness Impact Profile score from Baseline to Day 28 and day 56, day 84, Day 114, Day 144
The generic health status, the physical, mental and social aspects of health-related functioning and behavior aspectes will be measred through - The Sickness Impact Profile (All the items are scored dichotomously (no=0, yes=1); The items reported as "yes" are used to calculate the scores; higher scores indicate more health-related behavioral problems)
Measured: 144 days
Change from Baseline (Day 0) to Day 7, 15, 28, 56 in Zonuline test
Serum Zonuline test will be performed
Measured: 56 days
Change from Baseline Day 0 to Day 7 in the VAS-IBS questionnaire (Visual Analogue Scale for Irritable Bowel Syndrome) evaluated by Patient Journal Daily on each symptom
The VAS-IBS will be assessed through the Patient Journal. In the VAS-IBS the patients record the overall severity of each item on a 100 points line (very severe discomfort = 0 to no discomfort at all = 100).
Measured: 7 days
Change from Baseline Day 0 to Day 7 in the VAS-IBS questionnaire (The Visual Analogue Scale for Irritable Bowel Syndrome) evaluated by Investigator at Day 15, Day 28 and Day 56, Day 84, Day 114, Day 144
The Investigator will assess the symptoms in patients suffering from IBS - using the Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS) questionnaire. In the VAS-IBS the patients record the overall severity of each item on a 100 points line (very severe discomfort = 0 to no discomfort at all = 100).
Measured: 144 days
Number of AE occurrence
Adverse events will be monitored during all the visits till the end of the study and reported accordingly
Measured: 144 days
% of participants with withdrawal due to AE
Withdrawal due to adverse events will be monitored during all the visits till the end of the study and reported accordingly.
Measured: 144 days
Change from baseline in waist circumference assessed at Day 7,15, 28, 56,84
The waist circumference will be evaluated
Measured: 84 days
Change from baseline in number of stools will be assessed at Day 0, 7, 15, 28, 56, 84, 114, 144
Number of stools will be assessed
Measured: 144 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Nov 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With Constipation (IBS-C)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Devintec Sagl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEBIS International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240521
- Sponsor's protocol ID
- CBSDEV21072020
- Acronym
- RELAX
- Status last verified
- Jan 2022
- First submitted
- 17 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Crossover-Over Clinical Trial Investigating the Efficacy and Safety, Tolerability of GA-AT0119 in the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C)
- ClinicalTrials.gov ID
- NCT05240521
- Acronym / sponsor ID
- RELAX / CBSDEV21072020
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Devintec SaglIndustry (pharma, biotech, devices)
- Collaborators
- CEBIS International
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Irritable bowel syndrome (IBS) is a common functional bowel disorder that imposes a considerable burden on health-related quality of life (QOL) worldwide. Irritable Bowel Syndrome (IBS) is a common digestive disorder affecting 7-21% of the general population. IBS with predominant constipation (IBS-C) is a subtype of IBS that accounts for more than a third of the IBS diagnosed.
The study Sponsor, Devintec SAGL, presents GA-AT0119, which acts by forming a mechanical barrier on the intestinal mucosa thanks to xyloglucan and pea proteins avoiding the increased intestinal permeability, bacterial invasion to intestinal tissues, and subsequent intestinal inflammation. The formulation of GA-AT0119 is completed with chia seed powder which provides a laxative effect by retaining water in the intestine increasing stool bulk and accelerating fecal transit.
There is increasing evidence that the pathophysiology of IBS is multifaceted involving mucosal inflammation, visceral hypersensitivity, microbial dysbiosis, dietary factors, and altered intestinal permeability (IP). Several studies have shown increased intestinal permeability in patients with irritable bowel syndrome. Serum zonulin, a biomarker of impaired increased permeability, is increased in patients' constipation-predominant irritable bowel syndrome compared to a healthy population and the levels are comparable to celiac disease.
Detailed description
Each subject will be asked to sign the Informed Consent Form (ICF). The patients diagnosed with IBS-C will be randomized in 1:1 ratio. The treatment will be administrated according to the approved leaflet and study procedures. Eligible patients will be randomized to receive either GA-AT0119 or Placebo. Patients will be treated according to the approved leaflet. The study subjects will return at day 7, 15 and day 28 for evaluation. Each subject will undergo a washout period of 28 days. At Day 56 each subject will be evaluated and will receive the crossover therapy line and start administration. Subject will be evaluated at Day 84 at the end of the crossover period. Patients will be evaluated for constipation symptoms, global assessment for tolerability, safety. Each subject will receive a diary where bowel frequency, type and transit time will be completed during product administration. From visit 2 to visit 6, patients will be evaluated for treatment adherence and clinical symptoms recurrences. Each subject will complete 2 additional phone follow-ups Visit for safety reporting and clinical symptoms recurrences according to protocol. During the follow-up visits subject will be evaluated also by using Likert scale for Abdominal Pain and discomfort, Sickness Impact Profile score, IBS-VAS scale and IBS-QoL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A: GA-AT0119 / Placebo | Other | Other: ARM A, Other: ARM BCross-over Study |
| ARM B: Placebo / GA-AT0119 | Other | Other: ARM A, Other: ARM BCross-over Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult subjects over 18 years old;
- Subject willing to sign the informed consent;
- The ability to comply with study visits;
- Patients with constipation following diagnostic of IBS-C (Subtypes prevalent presentation of stool in IBS according to the Rome IV Criteria: IBS with constipation (IBS-C) - ( >25% hard stools and <25% loose stools)
Key exclusion criteria (9 listed)
- Use of gelatin tannate, diosmectite, probiotics, racecadotril or any other drugs or medical devices known to alter gastrointestinal motility or secretion within four weeks prior to enrolment
- Chronic diarrhea caused by cystic fibrosis, coeliac disease, food allergy, diabetes Chronic diarrhea caused by lactose, fructose, or sorbitol intolerance
- Diagnostic of IBS-D
- Use of prebiotics, fiber supplements, laxatives, 5-HT4 agonists, antispasmodic, antidepressants with 4 weeks prior study Baseline visit
- Immunodeficiencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARM A30 IBS-C patients will receive GA-AT0119 for 28 days, followed by a washout period of 28 days and Placebo for another 28 days | Other | ARM A: GA-AT0119 / Placebo, ARM B: Placebo / GA-AT0119 |
| ARM B30 IBS-C patients will receive Placebo for 28 days, followed by a washout period of 28 days and GA-AT0119 for another 28 days | Other | ARM A: GA-AT0119 / Placebo, ARM B: Placebo / GA-AT0119 |
Primary outcome
Change from baseline in Subjective Symptom Improvement assessed through Likert scale (Discomfort, Bloating Abdominal Pain) at day 7, 15, 28, 56, 84,114,144
Time frame: 144 days
The clinical symptoms that are going to be assessed through the 7 point Likert Scale are: Bloating, Discomfort, abdominal pain. Likert scale - level of acceptability: 1. - Totally unacceptable 2. - Unacceptable 3. - Slightly unacceptable 4. - Neutral 5. - Slightly acceptable 6. - Acceptable 7. - Perfectly Acceptable
Change from baseline in BMI assessed at Day 7,15, 28, 56,84
Time frame: 84 days
The BMI will be evaluated
Change from baseline in stool consistency will be assessed at Day 0, 7, 15, 28, 56, 84, 114, 144, through the Bristol Stool Scale.
Time frame: 144 days
Type of stool will be assessed according to the Bristol Stool Chart ((Stool Type 1 - severe constipation, Stool Type 2 - mild constipation, Stool Type 3 - normal, Stool Type 4 - normal, Stool Type 5 - lacking fiber, Stool Type 6 - mild diarrhea, Stool Type 6 - severe diarrhea)
Change from baseline score in IBS-QoL questionnaire (Information Sheet on the Irritable Bowel Syndrome - Quality of Life Measure) at Day 7, 15, Day 28 and Day 56, Day 84, Day 114, Day 144
Time frame: 144 days
Patients will respond to the IBS-QoL questionnaire. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.
Change of Sickness Impact Profile score from Baseline to Day 28 and day 56, day 84, Day 114, Day 144
Time frame: 144 days
The generic health status, the physical, mental and social aspects of health-related functioning and behavior aspectes will be measred through - The Sickness Impact Profile (All the items are scored dichotomously (no=0, yes=1); The items reported as "yes" are used to calculate the scores; higher scores indicate more health-related behavioral problems)
Change from Baseline (Day 0) to Day 7, 15, 28, 56 in Zonuline test
Time frame: 56 days
Serum Zonuline test will be performed
Change from Baseline Day 0 to Day 7 in the VAS-IBS questionnaire (Visual Analogue Scale for Irritable Bowel Syndrome) evaluated by Patient Journal Daily on each symptom
Time frame: 7 days
The VAS-IBS will be assessed through the Patient Journal. In the VAS-IBS the patients record the overall severity of each item on a 100 points line (very severe discomfort = 0 to no discomfort at all = 100).
Change from Baseline Day 0 to Day 7 in the VAS-IBS questionnaire (The Visual Analogue Scale for Irritable Bowel Syndrome) evaluated by Investigator at Day 15, Day 28 and Day 56, Day 84, Day 114, Day 144
Time frame: 144 days
The Investigator will assess the symptoms in patients suffering from IBS - using the Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS) questionnaire. In the VAS-IBS the patients record the overall severity of each item on a 100 points line (very severe discomfort = 0 to no discomfort at all = 100).
Number of AE occurrence
Time frame: 144 days
Adverse events will be monitored during all the visits till the end of the study and reported accordingly
% of participants with withdrawal due to AE
Time frame: 144 days
Withdrawal due to adverse events will be monitored during all the visits till the end of the study and reported accordingly.
Change from baseline in waist circumference assessed at Day 7,15, 28, 56,84
Time frame: 84 days
The waist circumference will be evaluated
Change from baseline in number of stools will be assessed at Day 0, 7, 15, 28, 56, 84, 114, 144
Time frame: 144 days
Number of stools will be assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARM A and ARM B in people with Irritable Bowel Syndrome With Constipation (IBS-C), run by Devintec Sagl at 4 sites in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Etropolska (00359 888 955 474, maria.etropolska@cebis-int.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Subjective Symptom Improvement assessed through Likert scale (Discomfort, Bloating Abdominal Pain) at day 7, 15, 28, 56, 84,114,144 (time frame: 144 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.