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Efficacy and Safety, Tolerability of GA-AT0119 in IBS-C (RELAX)

Primary Purpose

Irritable Bowel Syndrome With Constipation (IBS-C)

Status
Recruiting
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
ARM A
ARM B
Sponsored by
Devintec Sagl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation (IBS-C)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Outpatient clinic for individual practice for primary medical care Dr. Elenski EOODRecruiting
  • Medical Center Prolet EOODRecruiting
  • Medical Center Prolet EOOD
  • Ambulatory Practice for Primary Outpatient Medical Care SANA OODRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ARM A: GA-AT0119 / Placebo

ARM B: Placebo / GA-AT0119

Arm Description

Cross-over Study

Cross-over Study

Outcomes

Primary Outcome Measures

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
Change from baseline in BMI assessed at Day 7,15, 28, 56,84
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.
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
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
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
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
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
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
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
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
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
Number of stools will be assessed

Secondary Outcome Measures

Full Information

First Posted
January 17, 2022
Last Updated
February 4, 2022
Sponsor
Devintec Sagl
Collaborators
CEBIS International
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1. Study Identification

Unique Protocol Identification Number
NCT05240521
Brief Title
Efficacy and Safety, Tolerability of GA-AT0119 in IBS-C
Acronym
RELAX
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Devintec Sagl
Collaborators
CEBIS International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Constipation (IBS-C)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM A: GA-AT0119 / Placebo
Arm Type
Other
Arm Description
Cross-over Study
Arm Title
ARM B: Placebo / GA-AT0119
Arm Type
Other
Arm Description
Cross-over Study
Intervention Type
Other
Intervention Name(s)
ARM A
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
ARM B
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in Subjective Symptom Improvement assessed through Likert scale (Discomfort, Bloating Abdominal Pain) at day 7, 15, 28, 56, 84,114,144
Description
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
Time Frame
144 days
Title
Change from baseline in BMI assessed at Day 7,15, 28, 56,84
Description
The BMI will be evaluated
Time Frame
84 days
Title
Change from baseline in stool consistency will be assessed at Day 0, 7, 15, 28, 56, 84, 114, 144, through the Bristol Stool Scale.
Description
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)
Time Frame
144 days
Title
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
Description
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.
Time Frame
144 days
Title
Change of Sickness Impact Profile score from Baseline to Day 28 and day 56, day 84, Day 114, Day 144
Description
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)
Time Frame
144 days
Title
Change from Baseline (Day 0) to Day 7, 15, 28, 56 in Zonuline test
Description
Serum Zonuline test will be performed
Time Frame
56 days
Title
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
Description
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).
Time Frame
7 days
Title
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
Description
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).
Time Frame
144 days
Title
Number of AE occurrence
Description
Adverse events will be monitored during all the visits till the end of the study and reported accordingly
Time Frame
144 days
Title
% of participants with withdrawal due to AE
Description
Withdrawal due to adverse events will be monitored during all the visits till the end of the study and reported accordingly.
Time Frame
144 days
Title
Change from baseline in waist circumference assessed at Day 7,15, 28, 56,84
Description
The waist circumference will be evaluated
Time Frame
84 days
Title
Change from baseline in number of stools will be assessed at Day 0, 7, 15, 28, 56, 84, 114, 144
Description
Number of stools will be assessed
Time Frame
144 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Etropolska
Phone
00359 888 955 474
Email
maria.etropolska@cebis-int.com
Facility Information:
Facility Name
Outpatient clinic for individual practice for primary medical care Dr. Elenski EOOD
City
Plovdiv
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariya Armova
Phone
00359884268270
Email
mariyaarmova@gmail.com
Facility Name
Medical Center Prolet EOOD
City
Ruse
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petar Yanev
Phone
00359887842514
Email
drpepi0110@gmail.com
Facility Name
Medical Center Prolet EOOD
City
Ruse
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Ambulatory Practice for Primary Outpatient Medical Care SANA OOD
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zlatka Etropolska
Phone
00359878510845
Email
z.etropolska@medcogc.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety, Tolerability of GA-AT0119 in IBS-C

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