Status:
UNKNOWN
Efficacy and Safety, Tolerability of GA-AT0119 in IBS-C
Lead Sponsor:
Devintec Sagl
Collaborating Sponsors:
CEBIS International
Conditions:
Irritable Bowel Syndrome With Constipation (IBS-C)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 di...
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 lea...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05240521
Start Date
November 1 2021
End Date
August 31 2022
Last Update
February 15 2022
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Outpatient clinic for individual practice for primary medical care Dr. Elenski EOOD
Plovdiv, Bulgaria
2
Medical Center Prolet EOOD
Rousse, Bulgaria
3
Medical Center Prolet EOOD
Rousse, Bulgaria
4
Ambulatory Practice for Primary Outpatient Medical Care SANA OOD
Sofia, Bulgaria