Chronic Mesenteric IschemiaNCT06468774
Intestinal Ischemia Biomarker in Patients With Chronic Mesenteric Ischemia
An observational study of Chronic Mesenteric Ischemia and Median Arcuate Ligament Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Plasma Alpha glutathione S transferase (Alpha GST) has been previously demonstrated to be raised in patients with chronic mesenteric ischemia (CMI) caused by atherosclerosis and in patients with median arcuate ligament syndrome (MALS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Mesenteric Ischemia, Median Arcuate Ligament Syndrome, Crohn Disease
- What is being tested?
- Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- 10 Jun 2024to 31 May 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: CMI and MALS patients with the vascular surgery department, Oslo University Hospital, with a consensus diagnosis of MALS and a diagnosis of CMI and schedules operative or endovascular treatment. Control groups are the individuals under treatment with the Oslo University Hospital or regular blood donors at the hospital.
Inclusion Criteria: Above 18 years and has given informed written consent for treatment and study participation
For the patient groups :
Group 1: Has CTA or ultrasound diagnosed MALS and is scheduled operative treatment.
Group 2: Has CTA or ultrasound diagnosed CMI and is scheduled operative or endovascular treatment.
For the control group:
Group 3- Has ultrasound based diagnosis of cholelithiasis and is scheduled for cholecystectomy.
Group 4- Has established Mb Crohn diagnosis and under gastric lab follow-up. Group 5- Young healthy blood donors of mean age 45 years and has excluded MALS or CMi with ultrasound.
Group 6- Healthy blood donors of mean age 70 years and has excluded MALS or CMi with ultrasound.
Exclusion Criteria: Age less than 18 years Has nor given written consent.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Department of vascular surgery, Oslo University Hospital
Oslo, Oslo
Syed Sajid Hussain Kazmi, MD, PhD, 004792468309, sshkazmi@gmail.com
About this study
Official title: Intestinal Ischemia Biomarker and Quality of Life of the Patients With Chronic Mesenteric Ischemia and Median Arcuate Ligament Syndrome
Plasma Alpha glutathione S transferase (Alpha GST) has been previously demonstrated to be raised in patients with chronic mesenteric ischemia (CMI) caused by atherosclerosis and in patients with median arcuate ligament syndrome (MALS). Raised plasma level of Alpha GST has been demonstrated to decrease or normalize after surgical treatment of patients with CMI and MALS as compared with healthy individuals.
This study compares the plasma Alpha GST in patients with CMI and MALS with those with 1-Morbus Crohn, 2-Gallstone disease, and age-matched healthy individuals.
Besides, changes in the health-related quality of life (QoL) will be investigated in the study individuals.
Read the detailed description
Patients with CMI and MALS usually complain of postprandial abdominal pain, changes in food intake pattern, and weight loss. These symptoms are often shared with many other more common diseases. Therefore, the diagnosis of CMI, and especially MALS, is often an exclusion diagnosis. To this date, no biomarker of intestinal ischemia with sufficient sensitivity and specificity has been identified for routine clinical use.
In a previous study, raised levels of plasma Alpha glutathione S transferase (Alpha GST) (7.8 ng/mL) in patients with CMI caused by atherosclerosis and in the patients with MALS (8.4 ng/mL). The raised plasma level of Alpha GST has been demonstrated to decrease or normalize after surgical improvement of the intestinal circulation in patients with CMI and MALS as compared with healthy individuals (3.3 ng/mL). However, the study was not appropriately powered and did not include a control group with similar clinical symptoms as in the patients with CMI and MALS.
This study will compare the plasma Alpha GST levels in patients with CMI (n=30) and MALS (n=30) with 1-Morbus Crohn (n=30), 2-Gallstone disease (n=30), and age-matched healthy individuals (n=60).
The CMI and MALS patients diagnosed with CTA and duplex ultrasound and scheduled to have either endovascular (PTA or stent) or open surgery (mesenteric bypass ) treatment will be included in this study.
Duplex ultrasound will be used to exclude CMI and MALS in the individuals in the control groups. After inclusion in the study, venous blood samples will be taken to exclude renal failure and liver disease. The blood samples will be repeated within 3 months. The blood samples will be centrifuged and stored at -70 degrees until analyzed in batches with the ELISA technique. Participants in the control groups will be examined with duplex ultrasound at the time of inclusion in the study and agian at three months.
In the patient groups, i.e., CMI and MALS, the venous blood samples will be obtained before and 3 months after the treatment. The blood samples will be centrifuged and stored at -70 degrees until analyzed in batches with the ELISA technique.
The plasma levels of Alpha GST will be compared beside receiver operating characteristic curves (ROC), and the area under the curve(AUC) will be calculated.
In addition to Alpha GST, the plasma of the study individuals will also be tested for other potential markers of intestinal ischemia, i.e., intestinal fatty acid binding protein (i-FABP), citrulline, and ischemia-modified albumin (IMA).
The study will also follow the patients participating in the study for clinical changes in symptoms. In addition, patient demographics, comorbidities, treatment demographics, and complications of the treatment will be registered. A questionnaire has been constructed for the patient groups in the study to register the clinical signs and symptoms. The patients will fill out the questionnaire before and after the treatment. The study patients will be followed up after treatment at the outpatient clinic at 1 and 3 months and at 1, 2, 5, and 10 years. Duplex ultrasound will be performed at all follow-up time points.
Furthermore, changes in the health-related quality of life (QoL) will be investigated in the study individuals. The EuroQol 5D (EQ5D) questionnaire will be used to assess the QoL of the study patients. The patients will fill out the EQ5D at inclusion in the study and 1, 2, 5, and 10 years after treatment of CMI and MALS in the patient groups. EQ-5D can be converted to a single summary index by applying a formula that attaches weight to each of the levels in each dimension. The EQ-5D index is varying between 0 to 1 where 1 presents best health condition and 0 presenting the worst health state .
Information from the quality of life and the costs of treatment during the hospital stay will be used to estimate the quality-adjusted life years (QALY) and the cost-utility of treating patients with CMI and MALS.
- Conditions
- Chronic Mesenteric Ischemia, Median Arcuate Ligament Syndrome, Crohn Disease, Cholelithiasis
- Being tested
- Laparoscopic surgery
- Keywords
- Intestinal ishchemia biomarker, alpha GST, MALS, Chronic mesenteric ischemia
- Medical subject headings
- Median Arcuate Ligament Syndrome, Crohn Disease, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or surgery
Also called Percutaneous transluminal angioplasty (PTA) with stent, Open mesenteric bypass
The patients in the MALS group will be treated through transperitoneal ventral approach for the laparoscopic release of the celiac artery. Median arcuate ligament and any muscle or nerve tissue crossing the cranial surface of the celiac artery will be divided to release the celiac artery from compression.
In the patients with CMI open antegrade or retrograde bypass to celiac artery or superior mesenteric artery or both will be performed.
For operative treatment will be performed in general anaethesia whereas the endovacular treatment with PTA with stent for CMI will be performed in local anaethesia.
| Study group | Role | What they receive |
|---|---|---|
| Median arcuate ligament syndrome (MALS) | Patients with MALS Scheduled for laparoskopic decompression. Receives: Procedure: Laparoscopic surgery | |
| Chronic mesenteric ischemia (CMI) | Patients with CMI caused by atherosclerotic stenosis or occlusion of celiac artery, superior mesenteric artery ( one or both arteries ), and scheduled treatment with either PTA/stent or mesenteric bypass. Receives: Procedure: Laparoscopic surgery | |
| Morbus Crohn intestine | Patients with diagnosed Mb Crohn of intestine who does not have CMI or MALS excluded with duplex ultrasound. | |
| Cholilithiasis | Patients with diagnosed Cholilithiasis who is scheduled for operative chelecystectomy and does not have CMI or MALS, excluded with the help of duplex ultrasound. | |
| Blood donor (Young) | Healthy blood donor with a median age of 45 years, who does not have symptoms of mesenteric ischemia or MALS and has excluded these two conditions with the help of duplex ultrasound. | |
| Blood donor (Old) | Healthy blood donor with a median age of 70 years, who does not have symptoms of mesenteric ischemia or MALS and has excluded these two conditions with the help of duplex ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma alpha Glutathione S transferase
This study compares the plasma Alpha GST in patients with CMI (n=30) and MALS (n=30) with those with 1-Morbus Crohn (n=30), 2-Gallstone disease (n=30), and age-matched healthy individuals (n=60).
After inclusion in the study, blood tests will be performed to exclude renal failure and liver disease.
Venous blood samples will be obtained before and 3 months after treatment in the patients with CMI and MALS. Blood samples will also be obtained from the individuals in the control groups twice ( at inclusion and 3 months apart ). The blood samples will be centrifuged and stored at -70 degrees until analyzed in batches with the ELISA technique.
The plasma levels of Alpha GST in ng/mL before and after the intervention will be compared seperately for the differnt study groups.
Measured: 3 months
Secondary outcomes (6)
Health related quality of life (QoL)
Changes in the health-related quality of life (QoL) will be investigated. EuroQol 5D (EQ5D) questionnaire, which is a generic tool, will be used to assess the QoL of the study patients. EQ5D is a generic tool for the assessment of health related quality of life and is translated to Norwegian language and validated tool for the assessmeent of changes in the health related quality of life. The patients will fill out the EQ5D at inclusion in the study and 1, 2, 5, and 10 years after treatment of CMI and MALS in the patient groups. EQ5D has 5 questions with 5 levels of answers to each question. Level 1 will denote the best possible health status and level 5 denotes the worst health status for each of the 5 questions. It allows to a assess both physical and mental quality of health of the patients.
Measured: 5 years
Clinical outcomes of the treatment of CMI and MALS
Effect of treatment on the symptoms of CMI and MALS postoperatively at 30 and 90 days, and at 1, 2, 5 and 10 years. A study specific questionnaire has been deveolped to register the signs and symptoms of CMI and MALS. The patients in the study will fill-out the questionnaire before and after the treatment and will repeat it at every follow-up time-point. The patients in the study will be follow-up by the clinicians who are not directly involved with the study and therefore the clinical information obtained will be standarized and made independent of the clinician's background. The questionnaire will allow to assess if the clinical symptoms have improved or worsen during the follow-up.
Measured: 10 years
Cost utility analysis of the treatment of CMI and MALS
Quality adjusted life years (QALY ) estimation of the surgical and endovascular treatment of the patients with CMI and MALS. The costs of the treatment during the hospital stay will be calculated, compared with the costs of treatment given by the Norwegian Directorate of Health, QALY will be calculated based on the EQ5D results and the estimated treatment costs.
Measured: 5 years
Intestinal ishemia biomarkers for CMI and MALS
Secondary outcome mesure: Plasma levels of intestinal fatty acid binding protein (iFABP) in ng/mL. In the previous studies, this biomarker has been demonstrated to be raised in the plasma of patients with CMI. Venous blood obtained fra the study individuals before and 3 months after the treatment of CMI and MALS will be analyzed with ELISA technique to discover any changes in these plasma biomarkers of ischemia. The groups will be compared for the changes in the individual plasma levels of these biomarkers and tested for any association to intestinal ischemia.
Measured: 3 months
Plasma citruline
Plasma citroline is shown to be raised in the plasma of CMI patients in the previous studies. Venous blood samples will be taken before and 3 months after treatment of CMI and MALS patients and stored at -70 degrees until analyzed to find diffrences before and after the treatment and compare the diffrent study groups.
Measured: 3 months
Immune modified albumin (IMA)
Immune modified albumin (IMA) in ng/mL is shown to be raised in the blood samples of patients with CMI. Venous blood samples will be taken before and 3 months after treatment of study patients with MALS, CMI and control groups. The blood samples will be analyzed to compare the plasma levels before and after the treatment of CMI and MALS and also compared with the control groups.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start10 Jun 2024
- Primary completion31 May 2037 (estimated)
- Study completion31 May 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Mesenteric IschemiaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Sajid Hussain Kazmi, Oslo University Hospital
- Investigators
- Syed Sajid Hussain Kazmi, MD, PhD, Principal investigator, Department of vascular surgery, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468774
- Sponsor's protocol ID
- 607155
- Status last verified
- Jul 2025
- First submitted
- 12 Jun 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kazmi SSH, Safi N, Berge ST, Kazmi M, Sundhagen JO, Julien K, Thorsby PM, Anonsen KV, Medhus AW, Hisdal J. Plasma alpha-Glutathione S-Transferase in Patients with Chronic Mesenteric Ischemia and Median Arcuate Ligament Syndrome. Vasc Health Risk Manag. 2022 Jul 21;18:567-574. doi: 10.2147/VHRM.S365625. eCollection 2022.
PubMed 35903288
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Ischemia Biomarker and Quality of Life of the Patients With Chronic Mesenteric Ischemia and Median Arcuate Ligament Syndrome
- ClinicalTrials.gov ID
- NCT06468774
- Acronym / sponsor ID
- 607155
- Conditions
- Chronic Mesenteric Ischemia, Median Arcuate Ligament Syndrome, Crohn Disease, Cholelithiasis
- Keywords
- Intestinal ishchemia biomarker, alpha GST, MALS, Chronic mesenteric ischemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 31 May 2037 (estimated)
- Study completion
- 31 May 2037 (estimated)
- First posted
- 21 Jun 2024 (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.
Plasma Alpha glutathione S transferase (Alpha GST) has been previously demonstrated to be raised in patients with chronic mesenteric ischemia (CMI) caused by atherosclerosis and in patients with median arcuate ligament syndrome (MALS). Raised plasma level of Alpha GST has been demonstrated to decrease or normalize after surgical treatment of patients with CMI and MALS as compared with healthy individuals.
This study compares the plasma Alpha GST in patients with CMI and MALS with those with 1-Morbus Crohn, 2-Gallstone disease, and age-matched healthy individuals.
Besides, changes in the health-related quality of life (QoL) will be investigated in the study individuals.
Detailed description
Patients with CMI and MALS usually complain of postprandial abdominal pain, changes in food intake pattern, and weight loss. These symptoms are often shared with many other more common diseases. Therefore, the diagnosis of CMI, and especially MALS, is often an exclusion diagnosis. To this date, no biomarker of intestinal ischemia with sufficient sensitivity and specificity has been identified for routine clinical use.
In a previous study, raised levels of plasma Alpha glutathione S transferase (Alpha GST) (7.8 ng/mL) in patients with CMI caused by atherosclerosis and in the patients with MALS (8.4 ng/mL). The raised plasma level of Alpha GST has been demonstrated to decrease or normalize after surgical improvement of the intestinal circulation in patients with CMI and MALS as compared with healthy individuals (3.3 ng/mL). However, the study was not appropriately powered and did not include a control group with similar clinical symptoms as in the patients with CMI and MALS.
This study will compare the plasma Alpha GST levels in patients with CMI (n=30) and MALS (n=30) with 1-Morbus Crohn (n=30), 2-Gallstone disease (n=30), and age-matched healthy individuals (n=60).
The CMI and MALS patients diagnosed with CTA and duplex ultrasound and scheduled to have either endovascular (PTA or stent) or open surgery (mesenteric bypass ) treatment will be included in this study.
Duplex ultrasound will be used to exclude CMI and MALS in the individuals in the control groups. After inclusion in the study, venous blood samples will be taken to exclude renal failure and liver disease. The blood samples will be repeated within 3 months. The blood samples will be centrifuged and stored at -70 degrees until analyzed in batches with the ELISA technique. Participants in the control groups will be examined with duplex ultrasound at the time of inclusion in the study and agian at three months.
In the patient groups, i.e., CMI and MALS, the venous blood samples will be obtained before and 3 months after the treatment. The blood samples will be centrifuged and stored at -70 degrees until analyzed in batches with the ELISA technique.
The plasma levels of Alpha GST will be compared beside receiver operating characteristic curves (ROC), and the area under the curve(AUC) will be calculated.
In addition to Alpha GST, the plasma of the study individuals will also be tested for other potential markers of intestinal ischemia, i.e., intestinal fatty acid binding protein (i-FABP), citrulline, and ischemia-modified albumin (IMA).
The study will also follow the patients participating in the study for clinical changes in symptoms. In addition, patient demographics, comorbidities, treatment demographics, and complications of the treatment will be registered. A questionnaire has been constructed for the patient groups in the study to register the clinical signs and symptoms. The patients will fill out the questionnaire before and after the treatment. The study patients will be followed up after treatment at the outpatient clinic at 1 and 3 months and at 1, 2, 5, and 10 years. Duplex ultrasound will be performed at all follow-up time points.
Furthermore, changes in the health-related quality of life (QoL) will be investigated in the study individuals. The EuroQol 5D (EQ5D) questionnaire will be used to assess the QoL of the study patients. The patients will fill out the EQ5D at inclusion in the study and 1, 2, 5, and 10 years after treatment of CMI and MALS in the patient groups. EQ-5D can be converted to a single summary index by applying a formula that attaches weight to each of the levels in each dimension. The EQ-5D index is varying between 0 to 1 where 1 presents best health condition and 0 presenting the worst health state .
Information from the quality of life and the costs of treatment during the hospital stay will be used to estimate the quality-adjusted life years (QALY) and the cost-utility of treating patients with CMI and MALS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Median arcuate ligament syndrome (MALS) | – | Procedure: Laparoscopic surgeryPatients with MALS Scheduled for laparoskopic decompression. |
| Chronic mesenteric ischemia (CMI) | – | Procedure: Laparoscopic surgeryPatients with CMI caused by atherosclerotic stenosis or occlusion of celiac artery, superior mesenteric artery ( one or both arteries ), and scheduled treatment with either PTA/stent or mesenteric bypass. |
| Morbus Crohn intestine | – | –Patients with diagnosed Mb Crohn of intestine who does not have CMI or MALS excluded with duplex ultrasound. |
| Cholilithiasis | – | –Patients with diagnosed Cholilithiasis who is scheduled for operative chelecystectomy and does not have CMI or MALS, excluded with the help of duplex ultrasound. |
| Blood donor (Young) | – | –Healthy blood donor with a median age of 45 years, who does not have symptoms of mesenteric ischemia or MALS and has excluded these two conditions with the help of duplex ultrasound. |
| Blood donor (Old) | – | –Healthy blood donor with a median age of 70 years, who does not have symptoms of mesenteric ischemia or MALS and has excluded these two conditions with the help of duplex ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CMI and MALS patients with the vascular surgery department, Oslo University Hospital, with a consensus diagnosis of MALS and a diagnosis of CMI and schedules operative or endovascular treatment. Control groups are the individuals under treatment with the Oslo University Hospital or regular blood donors at the hospital.
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 |
|---|---|---|
| Laparoscopic surgeryAlso: Percutaneous transluminal angioplasty (PTA) with stent, Open mesenteric bypassThe patients in the MALS group will be treated through transperitoneal ventral approach for the laparoscopic release of the celiac artery. Median arcuate ligament and any muscle or nerve tissue crossing the cranial surface of the celiac artery will be divided to release the celiac artery from compression. In the patients with CMI open antegrade or retrograde bypass to celiac artery or superior mesenteric artery or both will be performed. For operative treatment will be performed in general anaethesia whereas the endovacular treatment with PTA with stent for CMI will be performed in local anaethesia. | Procedure or surgery | Chronic mesenteric ischemia (CMI), Median arcuate ligament syndrome (MALS) |
Primary outcome
Plasma alpha Glutathione S transferase
Time frame: 3 months
This study compares the plasma Alpha GST in patients with CMI (n=30) and MALS (n=30) with those with 1-Morbus Crohn (n=30), 2-Gallstone disease (n=30), and age-matched healthy individuals (n=60). After inclusion in the study, blood tests will be performed to exclude renal failure and liver disease. Venous blood samples will be obtained before and 3 months after treatment in the patients with CMI and MALS. Blood samples will also be obtained from the individuals in the control groups twice ( at inclusion and 3 months apart ). The blood samples will be centrifuged and stored at -70 degrees until analyzed in batches with the ELISA technique. The plasma levels of Alpha GST in ng/mL before and after the intervention will be compared seperately for the differnt study groups.
6 secondary outcomes
Health related quality of life (QoL)
Time frame: 5 years
Clinical outcomes of the treatment of CMI and MALS
Time frame: 10 years
Cost utility analysis of the treatment of CMI and MALS
Time frame: 5 years
Intestinal ishemia biomarkers for CMI and MALS
Time frame: 3 months
Plasma citruline
Time frame: 3 months
Immune modified albumin (IMA)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 35903288Kazmi SSH, Safi N, Berge ST, Kazmi M, Sundhagen JO, Julien K, Thorsby PM, Anonsen KV, Medhus AW, Hisdal J. Plasma alpha-Glutathione S-Transferase in Patients with Chronic Mesenteric Ischemia and Median Arcuate Ligament Syndrome. Vasc Health Risk Manag. 2022 Jul 21;18:567-574. doi: 10.2147/VHRM.S365625. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
Syed Sajid Hussain Kazmi, MD, PhD principal investigator
Department of vascular surgery, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Mesenteric Ischemia and Median Arcuate Ligament Syndrome, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syed Sajid Hussain Kazmi, MD, PhD (4792468309, sshkazmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma alpha Glutathione S transferase (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06468774, which also lists 1 linked publication.
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 30 Jul 2025.