Cystic FibrosisModulate-CFNCT04732910
Modulate-CF: Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulators
An observational study of Cystic Fibrosis, run by Charite University, Berlin, Germany at 4 sites in Germany.
Trial summary
This observational study evaluates the effect of therapy with cystic fibrosis transmembrane regulator (CFTR) modulators on CFTR function measured by the CFTR biomarker intestinal current measurement (ICM), nasal potential difference (NPD) and sweat chloride in a post-approval setting in patients with cystic fibrosis… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Treatment with cystic fibrosis transmembrane regulator (CFTR) modualtors Ivacaftor, Lumacaftor-Ivacaftor, Tezacaftor-Ivacaftor, Elexacaftor-Tezacaftor-Ivacaftor, Vanzacaftor-Tezacaftor-Deutivacaftor
- How many people
- 500 participants
- Where
- 4 sitesGermany
- Study dates
- 1 Jul 2018to 31 Dec 2027
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cystic Fibrosis patients
Who may be able to join
- Decision for cystic fibrosis (CF) transmembrane regulator (CFTR)-modulator therapy by the patient and the caring CF physician
- Signed informed consent form (ICF) and, where appropriate, signed assent form.
Who cannot join
- Ongoing participation in an investigational drug study (including studies investigating lumacaftor, tezacaftor or ivacaftor)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 4 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Simon Graeber, MD, +4930 450 566 587, simon.graeber@charite.de
- Recruiting
Justus-Liebig-University Giessen
Giessen
Lutz Nährlich, MD
- Recruiting
Hannover Medical School
Hanover
Anna-Maria Dittrich, MD, Dittrich.Anna-Maria@mh-hannover.de
- Recruiting
University of Heidelberg
Heidelberg
Olaf Sommerburg, MD
About this study
Official title: CFTR Biomarker Studie Bei Patient*Innen Mit Mukoviszidose Und CFTR-Modulatortherapie
This observational study evaluates the effect of therapy with cystic fibrosis transmembrane regulator (CFTR) modulators on CFTR function measured by the CFTR biomarker intestinal current measurement (ICM), nasal potential difference (NPD) and sweat chloride in a post-approval setting in patients with cystic fibrosis (CF).
Read the detailed description
Cystic fibrosis transmembrane regulator (CFTR) biomarker (intestinal current measurement (ICM), nasal potential difference (NPD), sweat chloride) before the start of therapy and 12 and 52 weeks after initiation of therapy Clinical parameters (anthropometry, lung function, lung magnetic resonance imaging (MRI), lung computer tomography (CT)) before the start of therapy and after initiation of therapy Assessment of airway secretion specimens before the start of therapy and after initiation of therapy
- Conditions
- Cystic Fibrosis
- Being tested
- Treatment with cystic fibrosis transmembrane regulator (CFTR) modualtors Ivacaftor, Lumacaftor-Ivacaftor, Tezacaftor-Ivacaftor, Elexacaftor-Tezacaftor-Ivacaftor, Vanzacaftor-Tezacaftor-Deutivacaftor
- Keywords
- CFTR, ICM, NPD
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with cystic fibrosis transmembrane regulator (CFTR) modualtors Ivacaftor, Lumacaftor-Ivacaftor, Tezacaftor-Ivacaftor, Elexacaftor-Tezacaftor-Ivacaftor, Vanzacaftor-Tezacaftor-DeutivacaftorDrug
observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal current measurement (ICM)
Absolute change from baseline of the chloride secretory ion current induced by cyclic adenosine monophosphate (cAMP) stimulation (forskolin/3-isobutyl-1-methylxanthine (IBMX)) in rectal tissue determined by intestinal current measurement (ICM) as a cystic fibrosis transmembrane conductance regulator (CFTR) biomarker
Measured: 12 weeks
Secondary outcomes (20)
Forced expiratory volume in 1 second (FEV1)
Absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) in spirometry
Measured: quaterly in the first year, yearly thereafter up to 5 years
Nasal potential Difference (NPD)
Absolute change from baseline total chloride response (zero chloride and isoproterenol) in nasal potential Difference (NPD) as a cystic fibrosis transmembrane conductance regulator (CFTR) biomarker
Measured: 12 weeks
Sweat chloride
Absolute change from baseline of the chloride concentration in Gibson-Cooke pilocarpine iontophoresis sweat test as a cystic fibrosis transmembrane conductance regulator (CFTR) biomarker
Measured: 12, 52 weeks, yearly thereafter up to 5 years
Lung clearance index (LCI)
Absolute change from baseline of the lung clearance index (LCI)
Measured: quaterly in the first year, yearly thereafter up to 5 years
Lung magnetic resonance imaging (MRI)
Absolute change from baseline in lung magnetic resonance imaging (MRI) score (Heidelberg MRI score ranging from 0 to 72 with higher values associated with worsening of the outcome; Eichinger et al. Eur J Radiol 2012)
Measured: 12, 52 weeks, yearly thereafter up to 5 years
Lung computer tomography
Absolute change from baseline in lung computer tomography (CT) score (Brody score ranging from 0 to 40,5 with higher values associated with worsening of the outcome; Brody et al. J Thorac Imaging 2006)
Measured: 52, 104 weeks
Paranasal sinus magnetic resonance imaging (MRI)
Absolute change from baseline in paranasal sinus magnetic resonance imaging (MRI) score (Sinunasal MRI score ranging from 0 to 68 with higher values associated with worsening of the outcome; Sommerburg et al. Ann Am Thorac Soc 2020)
Measured: 12, 52 weeks, yearly thereafter up to 5 years
Fecal elastase
Absolute change from baseline in fecal elastase-1 (FE-1) levels
Measured: 12, 52 weeks, yearly thereafter up to 5 years
Weight
Absolute change from baseline in weight
Measured: quaterly in the first year, yearly thereafter up to 5 years
Airway Microbiome
Absolute change in shannon index representing the alpha-diversity in sputum samples
Measured: 4, 12, 52 weeks, yearly thereafter up to 5 years
Sputum Elasticity
Absolute change in the elastic modulus (G') in sputum samples measured with a rheometer
Measured: 4, 12, 52 weeks, yearly thereafter up to 5 years
Sputum Viscocity
Absolute change in the viscous modulus (G'') in sputum samples measured with a rheometer
Measured: 4, 12, 52 weeks, yearly thereafter up to 5 years
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
The Cystic Fibrosis Questionnaire-Revised is a disease-specific health-related quality of life instrument for individuals with cystic fibrosis. Scores are standardized on a 0-100 scale. Minimum: 0; Maximum: 100. Higher scores indicate better health-related quality of life. Absolute change from baseline is calculated as follow-up score minus baseline score.
Measured: quarterly in the first year, yearly thereafter up to 5 years
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 is a 9-item self-report measure assessing depressive symptom severity over the past two weeks. Total score range: 0-27. Minimum: 0; Maximum: 27. Higher scores indicate more severe depressive symptoms. Absolute change from baseline is calculated as follow-up score minus baseline score.
Measured: quarterly in the first year, yearly thereafter up to 5 years
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 is a 7-item self-report measure assessing anxiety symptom severity over the past two weeks. Total score range: 0-21. Minimum: 0; Maximum: 21. Higher scores indicate more severe anxiety symptoms. Absolute change from baseline is calculated as follow-up score minus baseline score.
Measured: quarterly in the first year, yearly thereafter up to 5 years
Child Behavior Checklist for Ages 1½-5 (CBCL/1½-5)
The Child Behavior Checklist for Ages 1½-5 is a parent-reported measure assessing emotional and behavioral problems in children aged 18 months to 5 years. The Total Problems raw score ranges from 0-198. Minimum: 0; Maximum: 198. Higher scores indicate more emotional and behavioral problems. Absolute change from baseline is calculated as follow-up score minus baseline score.
Measured: quarterly in the first year, yearly thereafter up to 5 years
Child Behavior Checklist for Ages 6-18 (CBCL/6-18)
The Child Behavior Checklist for Ages 6-18 is a parent-reported measure of emotional and behavioral problems. Raw total problem scores range from 0-226. Minimum: 0; Maximum: 226. Higher scores indicate more behavioral and emotional problems. Absolute change from baseline is calculated as follow-up score minus baseline score.
Measured: quarterly in the first year, yearly thereafter up to 5 years
Youth Self-Report for Ages 11-18 (YSR/11-18)
The Youth Self-Report for Ages 11-18 is a self-report measure of emotional and behavioral problems, corresponding to the Child Behavior Checklist. Raw total problem scores range from 0-224. Minimum: 0; Maximum: 224. Higher scores indicate more behavioral and emotional problems. Absolute change from baseline is calculated as follow-up score minus baseline score.
Measured: quarterly in the first year, yearly thereafter up to 5 years
Strengths and Difficulties Questionnaire (SDQ)
The Strengths and Difficulties Questionnaire is a behavioral screening questionnaire. The Total Difficulties Score ranges from 0-40. Minimum: 0; Maximum: 40. Higher scores indicate more emotional and behavioral difficulties. Absolute change from baseline is calculated as follow-up score minus baseline score.
Measured: quarterly in the first year, yearly thereafter up to 5 years
22-Item Sino-Nasal Outcome Test (SNOT-22)
The 22-Item Sino-Nasal Outcome Test assesses symptom severity and health-related quality of life in sinonasal disease. The total score ranges from 0-110. Minimum: 0; Maximum: 110. Higher scores indicate more severe symptoms and poorer quality of life. Absolute change from baseline is calculated as follow-up score minus baseline score.
Measured: quarterly in the first year, yearly thereafter up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Jul 2018
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School, Heidelberg University, University of Giessen, University of Luebeck
- Responsible party
- Principal investigator, Simon Graeber, Charite University, Berlin, Germany
- Investigators
- Marcus A Mall, MD, Principal investigator, Charite University, Berlin, GermanySimon Y Graeber, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732910
- Sponsor's protocol ID
- 20012746
- Acronym
- Modulate-CF
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2021
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dohna M, Voskrebenzev A, Klimes F, Kaireit TF, Glandorf J, Pallenberg ST, Ringshausen FC, Hansen G, Renz DM, Wacker F, Dittrich AM, Vogel-Claussen J. PREFUL MRI for Monitoring Perfusion and Ventilation Changes after Elexacaftor-Tezacaftor-Ivacaftor Therapy for Cystic Fibrosis: A Feasibility Study. Radiol Cardiothorac Imaging. 2024 Apr;6(2):e230104. doi: 10.1148/ryct.230104.
PubMed 38573129Schaupp L, Addante A, Voller M, Fentker K, Kuppe A, Bardua M, Duerr J, Piehler L, Rohmel J, Thee S, Kirchner M, Ziehm M, Lauster D, Haag R, Gradzielski M, Stahl M, Mertins P, Boutin S, Graeber SY, Mall MA. Longitudinal effects of elexacaftor/tezacaftor/ivacaftor on sputum viscoelastic properties, airway infection and inflammation in patients with cystic fibrosis. Eur Respir J. 2023 Aug 3;62(2):2202153. doi: 10.1183/13993003.02153-2022. Print 2023 Aug.
PubMed 37414422Graeber SY, Renz DM, Stahl M, Pallenberg ST, Sommerburg O, Naehrlich L, Berges J, Dohna M, Ringshausen FC, Doellinger F, Vitzthum C, Rohmel J, Allomba C, Hammerling S, Barth S, Ruckes-Nilges C, Wielputz MO, Hansen G, Vogel-Claussen J, Tummler B, Mall MA, Dittrich AM. Effects of Elexacaftor/Tezacaftor/Ivacaftor Therapy on Lung Clearance Index and Magnetic Resonance Imaging in Patients with Cystic Fibrosis and One or Two F508del Alleles. Am J Respir Crit Care Med. 2022 Aug 1;206(3):311-320. doi: 10.1164/rccm.202201-0219OC.
PubMed 35536314Graeber SY, Vitzthum C, Pallenberg ST, Naehrlich L, Stahl M, Rohrbach A, Drescher M, Minso R, Ringshausen FC, Rueckes-Nilges C, Klajda J, Berges J, Yu Y, Scheuermann H, Hirtz S, Sommerburg O, Dittrich AM, Tummler B, Mall MA. Effects of Elexacaftor/Tezacaftor/Ivacaftor Therapy on CFTR Function in Patients with Cystic Fibrosis and One or Two F508del Alleles. Am J Respir Crit Care Med. 2022 Mar 1;205(5):540-549. doi: 10.1164/rccm.202110-2249OC.
PubMed 34936849
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CFTR Biomarker Studie Bei Patient*Innen Mit Mukoviszidose Und CFTR-Modulatortherapie
- ClinicalTrials.gov ID
- NCT04732910
- Acronym / sponsor ID
- Modulate-CF / 20012746
- Conditions
- Cystic Fibrosis
- Keywords
- CFTR, ICM, NPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Hannover Medical School, Heidelberg University, University of Giessen, University of Luebeck
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Feb 2021 (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.
This observational study evaluates the effect of therapy with cystic fibrosis transmembrane regulator (CFTR) modulators on CFTR function measured by the CFTR biomarker intestinal current measurement (ICM), nasal potential difference (NPD) and sweat chloride in a post-approval setting in patients with cystic fibrosis (CF).
Detailed description
Cystic fibrosis transmembrane regulator (CFTR) biomarker (intestinal current measurement (ICM), nasal potential difference (NPD), sweat chloride) before the start of therapy and 12 and 52 weeks after initiation of therapy Clinical parameters (anthropometry, lung function, lung magnetic resonance imaging (MRI), lung computer tomography (CT)) before the start of therapy and after initiation of therapy Assessment of airway secretion specimens before the start of therapy and after initiation of therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cystic Fibrosis patients
Key inclusion criteria (2 listed)
- Decision for cystic fibrosis (CF) transmembrane regulator (CFTR)-modulator therapy by the patient and the caring CF physician
- Signed informed consent form (ICF) and, where appropriate, signed assent form.
Key exclusion criteria (1 listed)
- Ongoing participation in an investigational drug study (including studies investigating lumacaftor, tezacaftor or ivacaftor)
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 |
|---|---|---|
| Treatment with cystic fibrosis transmembrane regulator (CFTR) modualtors Ivacaftor, Lumacaftor-Ivacaftor, Tezacaftor-Ivacaftor, Elexacaftor-Tezacaftor-Ivacaftor, Vanzacaftor-Tezacaftor-Deutivacaftorobservational | Drug | – |
Primary outcome
Intestinal current measurement (ICM)
Time frame: 12 weeks
Absolute change from baseline of the chloride secretory ion current induced by cyclic adenosine monophosphate (cAMP) stimulation (forskolin/3-isobutyl-1-methylxanthine (IBMX)) in rectal tissue determined by intestinal current measurement (ICM) as a cystic fibrosis transmembrane conductance regulator (CFTR) biomarker
20 secondary outcomes
Forced expiratory volume in 1 second (FEV1)
Time frame: quaterly in the first year, yearly thereafter up to 5 years
Nasal potential Difference (NPD)
Time frame: 12 weeks
Sweat chloride
Time frame: 12, 52 weeks, yearly thereafter up to 5 years
Lung clearance index (LCI)
Time frame: quaterly in the first year, yearly thereafter up to 5 years
Lung magnetic resonance imaging (MRI)
Time frame: 12, 52 weeks, yearly thereafter up to 5 years
Lung computer tomography
Time frame: 52, 104 weeks
Paranasal sinus magnetic resonance imaging (MRI)
Time frame: 12, 52 weeks, yearly thereafter up to 5 years
Fecal elastase
Time frame: 12, 52 weeks, yearly thereafter up to 5 years
Weight
Time frame: quaterly in the first year, yearly thereafter up to 5 years
Airway Microbiome
Time frame: 4, 12, 52 weeks, yearly thereafter up to 5 years
Sputum Elasticity
Time frame: 4, 12, 52 weeks, yearly thereafter up to 5 years
Sputum Viscocity
Time frame: 4, 12, 52 weeks, yearly thereafter up to 5 years
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time frame: quarterly in the first year, yearly thereafter up to 5 years
Patient Health Questionnaire-9 (PHQ-9)
Time frame: quarterly in the first year, yearly thereafter up to 5 years
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: quarterly in the first year, yearly thereafter up to 5 years
Child Behavior Checklist for Ages 1½-5 (CBCL/1½-5)
Time frame: quarterly in the first year, yearly thereafter up to 5 years
Child Behavior Checklist for Ages 6-18 (CBCL/6-18)
Time frame: quarterly in the first year, yearly thereafter up to 5 years
Youth Self-Report for Ages 11-18 (YSR/11-18)
Time frame: quarterly in the first year, yearly thereafter up to 5 years
Strengths and Difficulties Questionnaire (SDQ)
Time frame: quarterly in the first year, yearly thereafter up to 5 years
22-Item Sino-Nasal Outcome Test (SNOT-22)
Time frame: quarterly in the first year, yearly thereafter up to 5 years
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 24 Feb 2026.
- Derived from this study: PubMed 38573129Dohna M, Voskrebenzev A, Klimes F, Kaireit TF, Glandorf J, Pallenberg ST, Ringshausen FC, Hansen G, Renz DM, Wacker F, Dittrich AM, Vogel-Claussen J. PREFUL MRI for Monitoring Perfusion and Ventilation Changes after Elexacaftor-Tezacaftor-Ivacaftor Therapy for Cystic Fibrosis: A Feasibility Study. Radiol Cardiothorac Imaging. 2024 Apr;6(2):e230104. doi: 10.1148/ryct.230104.
- Derived from this study: PubMed 37414422Schaupp L, Addante A, Voller M, Fentker K, Kuppe A, Bardua M, Duerr J, Piehler L, Rohmel J, Thee S, Kirchner M, Ziehm M, Lauster D, Haag R, Gradzielski M, Stahl M, Mertins P, Boutin S, Graeber SY, Mall MA. Longitudinal effects of elexacaftor/tezacaftor/ivacaftor on sputum viscoelastic properties, airway infection and inflammation in patients with cystic fibrosis. Eur Respir J. 2023 Aug 3;62(2):2202153. doi: 10.1183/13993003.02153-2022. Print 2023 Aug.
- Derived from this study: PubMed 35536314Graeber SY, Renz DM, Stahl M, Pallenberg ST, Sommerburg O, Naehrlich L, Berges J, Dohna M, Ringshausen FC, Doellinger F, Vitzthum C, Rohmel J, Allomba C, Hammerling S, Barth S, Ruckes-Nilges C, Wielputz MO, Hansen G, Vogel-Claussen J, Tummler B, Mall MA, Dittrich AM. Effects of Elexacaftor/Tezacaftor/Ivacaftor Therapy on Lung Clearance Index and Magnetic Resonance Imaging in Patients with Cystic Fibrosis and One or Two F508del Alleles. Am J Respir Crit Care Med. 2022 Aug 1;206(3):311-320. doi: 10.1164/rccm.202201-0219OC.
- Derived from this study: PubMed 34936849Graeber SY, Vitzthum C, Pallenberg ST, Naehrlich L, Stahl M, Rohrbach A, Drescher M, Minso R, Ringshausen FC, Rueckes-Nilges C, Klajda J, Berges J, Yu Y, Scheuermann H, Hirtz S, Sommerburg O, Dittrich AM, Tummler B, Mall MA. Effects of Elexacaftor/Tezacaftor/Ivacaftor Therapy on CFTR Function in Patients with Cystic Fibrosis and One or Two F508del Alleles. Am J Respir Crit Care Med. 2022 Mar 1;205(5):540-549. doi: 10.1164/rccm.202110-2249OC.
- 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.
Marcus A Mall, MD principal investigator
Charite University, Berlin, Germany
Simon Y Graeber, MD principal investigator
Charite University, Berlin, Germany
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Charite University, Berlin, Germany at 4 sites in Germany.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. 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 Germany. 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 Simon Y Graeber, MD (+4930 450 566 587, simon.graeber@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal current measurement (ICM) (time frame: 12 weeks). 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 NCT04732910, which also lists 4 linked publications.
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 24 Feb 2026.