Crohn DiseasePhase 3NCT04921033
Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease
A Phase 3 study testing EEN (Nestle Modulen®) and Standart of care in people with Crohn Disease and Nutrient; Excess, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
Inflammatory bowel diseases are chronic and progressive entities, triggered by exposure to environmental factors in individuals with a genetic background. One of the most common environmental factors is the type of diet which is a key influencer on pathogenesis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease, Nutrient; Excess, Remission/Regression
- What is being tested?
- EEN (Nestle Modulen®) and Standart of care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Jan 2026
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects, aged between 18-75 years with a diagnosis of ileocolonic Crohn's disease (CD) confirmed using endoscopy and/or imaging technology at most 3 months prior.
- Participant or his/her legal representative have voluntarily signed and dated an informed consent approved by and compliant with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Adequate cardiac, renal, and hepatic function as determined by the Principal Investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that do not indicate an abnormal clinical condition that would place the participant at undue risk preclude participation in the study.
- Participant must be able to orally administer study medication/nutrient or have a designee or Healthcare Professional who can assist
Who cannot join
- Previous or current use of any medication for Crohn's disease such as biologics, immunomodulators (e.g., methotrexate, azathioprine, 6-mercaptopurine, JAK inhibitor, alpha-integrin), and corticosteroids
- Presence of complications (Fistula, abscess, fibrotic disease, imminent risk of surgery)
- Participants with a poorly controlled medical condition such as uncontrolled diabetes with a documented history of recurrent infections, unstable ischemic heart disease, moderate to severe congestive heart failure (New York Heart Association [NYHA] class III or IV), recent cerebrovascular accident, and any other condition which, in the opinion of the Investigator or the sponsor, would put the participant at risk by participation in the protocol
- Participants with positive C. difficile stool assay at screening.
- Rescue therapy with steroids, depending on the severity of the disease will be initiated for patients in the EEN group who do not respond clinically and will be excluded from the study. If the number of clinically unresponsive patients was greater than 25% of the total EEN population, the study will be stopped. Criteria for clinical response are described in the "Outcome Measures" section.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Duzce University School of Medicine
Düzce, 81620
Salih Tokmak, +905052532698, salihtokmak@duzce.edu.tr
About this study
Official title: Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease (XENIC): an Open-label, Multicenter, Prospective, Randomized Clinical Trial
Inflammatory bowel diseases are chronic and progressive entities, triggered by exposure to environmental factors in individuals with a genetic background.
One of the most common environmental factors is the type of diet which is a key influencer on pathogenesis. Nutrients alter the intestinal microbiota, thus changing the intestinal permeability. The Western-type diet encompasses sugar, fat, and protein-rich products that have some deleterious effects on the intestinal microbiome compared to the plant-based Mediterranean-type diet.
Based on this fact, diet-based therapeutic efforts have been used extensively in pediatric Crohn's disease patients and there is strong evidence that exclusive enteral nutrition (EEN) is as effective as corticosteroids to induce both clinical and endoscopic remission but this treatment strategy is underutilized in adults.
- Conditions
- Crohn Disease, Nutrient; Excess, Remission/Regression
- Being tested
- EEN (Nestle Modulen®), Standart of care
- Keywords
- enteral nutrition, induction of remission, Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEN (Nestle Modulen®)Dietary supplement
35kcal/kg/day for every patient
Standart of careDrug
Also called Budesonide (Budenofalk®), Prednisolone (Deltacortril®), Azathioprine (Imuran®)
- Budesonide 9mg/day for mild disease
- Prednisolone 1mg/kg, maximum 40mg/day in decreasing doses (40mg for 4 weeks followed by a fixed taper for 6 weeks) for moderate-to-severe disease for 12 weeks.
- Patients with moderate to severe disease in the steroid group will also receive 2mg/kg azathioprine. The dose of azathioprine will be adjusted according to abnormalities of white blood cell (WBC) count, platelet count, liver function tests (LFTs; i.e. alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase), lipase, blood urea nitrogen (BUN), and serum creatinine.
| Study group | Role | What they receive |
|---|---|---|
| Exclusive Enteral Nutrition | Experimental | 35kcal/kg/day EEN (Nestle Modulen®) - Subjects will take medicine and EEN solution orally themselves. Receives: Dietary Supplement: EEN (Nestle Modulen®) |
| Standard of care | Active comparator | * Budesonide 9mg/day for mild disease
* Prednisolone 1mg/kg, maximum 40mg/day in decreasing doses (40mg for 4 weeks followed by a fixed taper for 6 weeks) for moderate-to-severe disease for 12 weeks.
* Patients with moderate-to-severe disease in the steroid group will also receive 2mg/kg azathioprine. The dose of azathioprine will be adjusted according to abnormalities of white blood cell (WBC) count, platelet count, liver function tests (LFTs; i.e. alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase), lipase, blood urea nitrogen (BUN), and serum creatinine. Receives: Drug: Standart of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with mucosal healing
Defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤2, at 12 weeks after randomization. The ileocolonoscopies will be evaluated by the site.
SES-CD is an index for determining the severity of Crohn's disease. The SES-CD considers size of ulcerations, ulcerated surface, effected surface and the presence of narrowings, evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 60 where higher scores indicate more severe endoscopic activity.
Measured: 12 weeks
Percentage of patients that tolerate the EEN by week 12
Defined as withdrawal from the study from randomization through 12 weeks after randomization
Measured: 12 weeks
Secondary outcomes (11)
Endoscopic response
Defined as decrease in SES-CD > 50% from baseline at 12 weeks after randomization
Measured: 12 weeks
Mean change from baseline in SES-CD at 12 weeks after randomization
Mean change from baseline in SES-CD
Measured: 12 weeks
Mean change from baseline in CDAI over time (Time Frame: Baseline, 4, 8 and 12 weeks after randomization)
The Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. Participants were asked to record the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI: presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. The CDAI is the sum of the products of each item multiplied by a weighting factor and generally ranges from 0 up to 600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change from baseline indicates improvement.
Measured: 12 weeks
Time to clinical remission (Time frame: from randomization through 12 weeks after randomization)
Clinical remission was defined as:
- CDAI < 150
- PRO-2 abdominal pain (AP) score≤1 (7 day average) and liquid/very soft stool frequency (SF) score≤3 (7 day average)
Two-item Patient Reported Outcome (PRO-2) is a health outcome directly reported by the patient to quantify a treatment's efficacy that is derived from CDAI diary card. Participants were asked to record daily number of liquid or very soft stools and the severity of abdominal pain (defined as; 0=none, 1=mild, 2=moderate 3=severe). PRO-2 is the sum of the products of each item multiplied by a weighing factor. PRO-2 scores that correspond to CDAI thresholds are:
Mild Moderate Severe CDAI 150 220 450 PRO-2 8 14 34
Measured: 12 weeks
Time to clinical response (Time frame: from randomization through 12 weeks after randomization)
Clinical response was defined as:
- CDAI reduction ≥100 from baseline
- PRO-2 reduction ≥8 from baseline
Measured: 12 weeks
Mean change from baseline in C-reactive protein (CRP) over time (Time Frame: 4, 8 and 12 weeks after randomization)
Changes in CRP levels
Measured: 12 weeks
Mean change from baseline in fecal calprotectin (FC) over time (Time Frame: 4, 8 and 12 weeks after randomization)
Changes in fecal calprotectin levels
Measured: 12 weeks
Mean change from baseline in PRO-2 (Time Frame: Baseline and 12 weeks after randomization)
Two-item Patient Reported Outcome (PRO-2) is a health outcome directly reported by the patient to quantify a treatment's efficacy that is derived from CDAI diary card. Participants were asked to record daily number of liquid or very soft stools and the severtiy of abdominal pain (defined as; 0=none, 1=mild, 2=moderate 3=severe). PRO-2 is the sum of the products of each item multiplied by a weighing factor. PRO-2 scores that correspond to CDAI thresholds are:
Mild Moderate Severe CDAI 150 220 450 PRO-2 8 14 34
Measured: 12 weeks
Change from baseline in SIBDQ total score (Time Frame: Baseline and 12 weeks after randomization)
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a 10-item HrQOL questionnaire designed to quantify the changes in patients' daily activity, related to Crohn's disease symptoms. Participants were asked questions about physical, social, emotional, and systemic aspects and scored on a 7-point scale from 1 (severe problem) to 7 (no problems at all). The score ranges from 1 to 70 where higher scores indicate better HrQOL.
Measured: 12 weeks
Change in Robarts Histopathology Index (RHI) (Time Frame: Baseline and 12 weeks after randomization)
RHI is a research tool used to quantify the histologic changes and to assess the degree of inflammation in the mucosa.
RHI= 1xchronic inflammatory infiltrate level (4 levels)
- 2 x lamina propria neutrophils (4 levels)
- 3 x neutrophils in epithelium (4 levels)
- 5 x erosion or ulceration (4 levels)
The total score ranges from 0 (no disease activity) to 33 (severe disease activity). RHI≤3 corresponds to histologic remission.
Measured: 12 weeks
Number of Crohn's disease-related hospitalizations after randomization (Time Frame: From randomization through 12 weeks after randomization)
Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. Hospitalization due to emergency was defined as a hospitalization admitted through the emergency department.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Mar 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open-label, randomized, multicenter, interventional, parallel-group study, designed to evaluate the efficacy and tolerability of EEN in inducing clinical remission at 12 weeks in subjects with ileocaecal CD. Patients will receive EEN for 8 weeks, initially building up to the full required volume of formula over the first 3 to 4 days, depending on tolerance and side effects After the completion of the period of EEN, foods will be reintroduced slowly and supplementary enteral nutrition will be continued for another 4 weeks. A total of 256 patients with ileocaecal CD will be randomized in a 1:1 ratio to receive steroids and EEN. Each of the treatment arms will comprise 128 subjects. In order to make the groups comparable, randomization will be stratified according to the severity of the disease according to Crohn's Disease Activity Index (CDAI): 1. CDAI between 150-220 --\> Mild 2. CDAI between 220-450 --\> Moderate 3. CDAI\>450 --\> Severe
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salih Tokmak, Duzce University
- Investigators
- Salih Tokmak, Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921033
- Sponsor's protocol ID
- EEN in ileocaecal Crohn's
- Status last verified
- Oct 2022
- First submitted
- 4 Jun 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR) will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease (XENIC): an Open-label, Multicenter, Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04921033
- Acronym / sponsor ID
- EEN in ileocaecal Crohn's
- Conditions
- Crohn Disease, Nutrient; Excess, Remission/Regression
- Keywords
- enteral nutrition, induction of remission, Crohn's disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 10 Jun 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.
Inflammatory bowel diseases are chronic and progressive entities, triggered by exposure to environmental factors in individuals with a genetic background.
One of the most common environmental factors is the type of diet which is a key influencer on pathogenesis. Nutrients alter the intestinal microbiota, thus changing the intestinal permeability. The Western-type diet encompasses sugar, fat, and protein-rich products that have some deleterious effects on the intestinal microbiome compared to the plant-based Mediterranean-type diet.
Based on this fact, diet-based therapeutic efforts have been used extensively in pediatric Crohn's disease patients and there is strong evidence that exclusive enteral nutrition (EEN) is as effective as corticosteroids to induce both clinical and endoscopic remission but this treatment strategy is underutilized in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, randomized, multicenter, interventional, parallel-group study, designed to evaluate the efficacy and tolerability of EEN in inducing clinical remission at 12 weeks in subjects with ileocaecal CD. Patients will receive EEN for 8 weeks, initially building up to the full required volume of formula over the first 3 to 4 days, depending on tolerance and side effects After the completion of the period of EEN, foods will be reintroduced slowly and supplementary enteral nutrition will be continued for another 4 weeks. A total of 256 patients with ileocaecal CD will be randomized in a 1:1 ratio to receive steroids and EEN. Each of the treatment arms will comprise 128 subjects. In order to make the groups comparable, randomization will be stratified according to the severity of the disease according to Crohn's Disease Activity Index (CDAI): 1. CDAI between 150-220 --> Mild 2. CDAI between 220-450 --> Moderate 3. CDAI>450 --> Severe
| Arm | Type | Receives |
|---|---|---|
| Exclusive Enteral Nutrition | Experimental | Dietary Supplement: EEN (Nestle Modulen®)35kcal/kg/day EEN (Nestle Modulen®) - Subjects will take medicine and EEN solution orally themselves. |
| Standard of care | Active comparator | Drug: Standart of care* Budesonide 9mg/day for mild disease * Prednisolone 1mg/kg, maximum 40mg/day in decreasing doses (40mg for 4 weeks followed by a fixed taper for 6 weeks) for moderate-to-severe disease for 12 weeks. * Patients with moderate-to-severe disease in the steroid group will also receive 2mg/kg azathioprine. The dose of azathioprine will be adjusted according to abnormalities of white blood cell (WBC) count, platelet count, liver function tests (LFTs; i.e. alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase), lipase, blood urea nitrogen (BUN), and serum creatinine. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects, aged between 18-75 years with a diagnosis of ileocolonic Crohn's disease (CD) confirmed using endoscopy and/or imaging technology at most 3 months prior.
- Participant or his/her legal representative have voluntarily signed and dated an informed consent approved by and compliant with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Adequate cardiac, renal, and hepatic function as determined by the Principal Investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that do not indicate an abnormal clinical condition that would place the participant at undue risk preclude participation in the study.
- Participant must be able to orally administer study medication/nutrient or have a designee or Healthcare Professional who can assist
Key exclusion criteria (5 listed)
- Previous or current use of any medication for Crohn's disease such as biologics, immunomodulators (e.g., methotrexate, azathioprine, 6-mercaptopurine, JAK inhibitor, alpha-integrin), and corticosteroids
- Presence of complications (Fistula, abscess, fibrotic disease, imminent risk of surgery)
- Participants with a poorly controlled medical condition such as uncontrolled diabetes with a documented history of recurrent infections, unstable ischemic heart disease, moderate to severe congestive heart failure (New York Heart Association [NYHA] class III or IV), recent cerebrovascular accident, and any other condition which, in the opinion of the Investigator or the sponsor, would put the participant at risk by participation in the protocol
- Participants with positive C. difficile stool assay at screening.
- Rescue therapy with steroids, depending on the severity of the disease will be initiated for patients in the EEN group who do not respond clinically and will be excluded from the study. If the number of clinically unresponsive patients was greater than 25% of the total EEN population, the study will be stopped. Criteria for clinical response are described in the "Outcome Measures" section.
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 |
|---|---|---|
| EEN (Nestle Modulen®)35kcal/kg/day for every patient | Dietary supplement | Exclusive Enteral Nutrition |
| Standart of careAlso: Budesonide (Budenofalk®), Prednisolone (Deltacortril®), Azathioprine (Imuran®)* Budesonide 9mg/day for mild disease * Prednisolone 1mg/kg, maximum 40mg/day in decreasing doses (40mg for 4 weeks followed by a fixed taper for 6 weeks) for moderate-to-severe disease for 12 weeks. * Patients with moderate to severe disease in the steroid group will also receive 2mg/kg azathioprine. The dose of azathioprine will be adjusted according to abnormalities of white blood cell (WBC) count, platelet count, liver function tests (LFTs; i.e. alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase), lipase, blood urea nitrogen (BUN), and serum creatinine. | Drug | Standard of care |
Primary outcome
Percentage of participants with mucosal healing
Time frame: 12 weeks
Defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤2, at 12 weeks after randomization. The ileocolonoscopies will be evaluated by the site. SES-CD is an index for determining the severity of Crohn's disease. The SES-CD considers size of ulcerations, ulcerated surface, effected surface and the presence of narrowings, evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 60 where higher scores indicate more severe endoscopic activity.
Percentage of patients that tolerate the EEN by week 12
Time frame: 12 weeks
Defined as withdrawal from the study from randomization through 12 weeks after randomization
11 secondary outcomes
Endoscopic response
Time frame: 12 weeks
Mean change from baseline in SES-CD at 12 weeks after randomization
Time frame: 12 weeks
Mean change from baseline in CDAI over time (Time Frame: Baseline, 4, 8 and 12 weeks after randomization)
Time frame: 12 weeks
Time to clinical remission (Time frame: from randomization through 12 weeks after randomization)
Time frame: 12 weeks
Time to clinical response (Time frame: from randomization through 12 weeks after randomization)
Time frame: 12 weeks
Mean change from baseline in C-reactive protein (CRP) over time (Time Frame: 4, 8 and 12 weeks after randomization)
Time frame: 12 weeks
Mean change from baseline in fecal calprotectin (FC) over time (Time Frame: 4, 8 and 12 weeks after randomization)
Time frame: 12 weeks
Mean change from baseline in PRO-2 (Time Frame: Baseline and 12 weeks after randomization)
Time frame: 12 weeks
Change from baseline in SIBDQ total score (Time Frame: Baseline and 12 weeks after randomization)
Time frame: 12 weeks
Change in Robarts Histopathology Index (RHI) (Time Frame: Baseline and 12 weeks after randomization)
Time frame: 12 weeks
Number of Crohn's disease-related hospitalizations after randomization (Time Frame: From randomization through 12 weeks after randomization)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR) will be shared
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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.
Salih Tokmak principal investigator
Duzce University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EEN (Nestle Modulen®) and Standart of care in people with Crohn Disease and Nutrient; Excess, run by Duzce University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 18 Oct 2022. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Salih Tokmak (0905052532698, salihtokmak@duzce.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with mucosal healing (time frame: 12 weeks). The study lists 2 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 18 Oct 2022.