Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Phase 2/3MODIFI-IBDNCT07582458
Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)
A Phase 2/3 study testing Modafinil in people with Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Chronic Fatigue, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
The goal of this clinical trial is to learn if modafinil can treat severe fatigue in adults aged 18 to 75 years with quiescent inflammatory bowel disease (IBD). The main questions it aims to answer are: Does modafinil reduce fatigue more effectively than placebo, as measured by the mean difference in section I of the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Chronic Fatigue
- What is being tested?
- Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesNetherlands
- Study dates
- 3 Aug 2026to Jun 2027
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
- Age between 18 to 75 years at screening.
- ≥1 year diagnosis of IBD, based on a combination of clinical, endoscopic, histologic and radiologic criteria
- Chronic fatigue for at least six months
- Severe fatigue as confirmed with a score of ≥11 on section I of the IBD-F
- Clinically quiescent IBD with a Harvey Bradshaw Index (HBI) <5 for CD patients or a Simple Colitis Clinical Activity Index (SCCAI) ≤2 for patients with UC or IBD-unclassified
- Faecal calprotectin <250 µg/g
- Stable IBD medication for ≥3 months before screening visit and no change in IBD medication planned for ≥3 months
Who cannot join
- Contraindications for the use of modafinil, such as:
- Uncontrolled hypertension
- Cardiac arrhythmia
- A history of left ventricular hypertrophy or cor pulmonale, and in patients with mitral valve prolapse who have previously developed mitral valve prolapse syn-drome during treatment with central nervous system stimulants
- Patients with hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption
- Patients using medication which interacts clinically significant with modafinil, see section 3.3 'Mechanism of action \& Drug class'
Show all 37Show fewer
- Patients using pharmacological agents with similar effects to modafinil, like central nerv-ous system (CNS) stimulants or other wakefulness-promoting drugs such as methylphenidate and amphetamines
- Surgery before or during study period that impacts ability to participate in this study, per investigator judgement
- Participation in another intervention study (excl. registries and post marketing studies)
- Pregnancy or nursing at the moment of screening or planned pregnancy within two months after last dose
- People with a diagnosis of drug or alcohol dependence syndrome will be excluded
- Comorbidities or confirmed diagnoses known to cause fatigue, which may influence study outcomes, including but not limited to:
- Anaemia (Hb <7.0 mmol/l for women and <8.0 mmol/l for men) and which is judged as clinically significant by the investigator
- Folate deficiency (<6.0 nmol/l)
- Iron deficiency (ferritin <20 g/l for women and <25 g/L for men)
- Vitamin B12 deficiency (<148 pmol/l)
- Liver insufficiency defined by an ALT or AST >2x ULN or total bilirubin > 2 mg/dL
- Renal insufficiency defined by an estimated glomerular filtration rate < 45 mL/min, calculated using the Chronic Kidney Disease-Epidemiology Collaboration equation and/or a serum creatinine >178 μmol/L (2mg/dL)
- Auto-immune disorders such as primary sclerosing cholangitis, rheumatoid ar-thritis, systemic lupus erythematosus or coeliac disease
- Uncontrolled or recently diagnosed depression
- Active suicidal ideation
- Bipolar disorder
- Schizophrenia or other psychotic disorders
- Other psychiatric disorders that may interfere with the study as judged by the investigators
- History or current anxiety or sleep disorders
- Substance dependence disorders (e.g. alcohol, cannabis, drugs)
- Evidence, history, or suspicion of infectious diseases that may interfere with the study as judged by the investigators
- Active Epstein-Barr virus or cytomegalovirus infection
- Endocrinological disorders such as uncontrolled diabetes mellitus, untreated hy-pothyroidism, hypoadrenalism or hypogonadism
- Neurological disorders such as multiple sclerosis, dementia, Parkinson's disease or myasthenia gravis
- Heart failure
- Chronic obstructive pulmonary disease
- Obstructive sleep apnoea
- Active malignancy (exception of malignancies adequately treated with resection for non-metastatic basal cell carcinoma)
- Long/post-COVID
- Patients who are not able to complete the Dutch questionnaires in an online form
- Has a clinically significant concurrent disease or relevant laboratory abnormality or a history of illness or medical condition that in the investigator's opinion could confound the study results or increase the participant's risk by taking part in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Rijnstate
Arnhem, Gelderland, 6815 AD
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525GA
About this study
Official title: Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease: a Multicentre,Randomised, Double-blind, Placebo-controlled, Clinical Trial (MODIFI-IBD Trial)
The goal of this clinical trial is to learn if modafinil can treat severe fatigue in adults aged 18 to 75 years with quiescent inflammatory bowel disease (IBD). The main questions it aims to answer are:
Does modafinil reduce fatigue more effectively than placebo, as measured by the mean difference in section I of the IBD-F questionnaire at week 8? Is modafinil safe and well tolerated in patients with quiescent IBD and severe fatigue?
Read more
Researchers will compare modafinil to placebo to see if modafinil improves fatigue outcomes.
Participants will:
attend one screening visit including assessment of disease activity, blood tests, stool testing, and an ECG; take modafinil or placebo for 8 weeks, starting at 100 mg daily with possible dose increases based on response and tolerability; complete online questionnaires at baseline, week 4, week 8, and week 12 about fatigue, quality of life, sleep, mood, and work productivity; be contacted regularly during the treatment period to discuss effect and side effects of the study medication; complete an online effort-based decision-making task at baseline and week 8.
Read the detailed description
Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is frequently associated with persistent fatigue, even during clinical remission. Fatigue is one of the most burdensome symptoms reported by patients with IBD and is associated with impaired quality of life, reduced daily functioning, and decreased work productivity. Despite its high prevalence and clinical relevance, there are currently no established pharmacological treatment options for fatigue in patients with quiescent IBD.
Modafinil is a centrally acting wakefulness-promoting agent approved for excessive daytime sleepiness in narcolepsy. It has been used for many years and has a well-characterized safety profile. Although its exact mechanism of action is not fully understood, available evidence suggests that modafinil enhances wakefulness and alertness through effects on central dopaminergic signalling. Because fatigue in IBD may involve central mechanisms related to motivation, alertness, and effort processing, modafinil is a biologically plausible candidate treatment for this population. Preliminary clinical observations have suggested that modafinil may reduce fatigue in patients with quiescent IBD, but controlled trial data are not available.
This study is a multicentre, randomized, double-blind, placebo-controlled, multicentre, clinical trial designed to evaluate the efficacy, safety, and tolerability of modafinil in adults with quiescent IBD and severe fatigue. Participants are randomized in a 1:1 ratio to receive modafinil or matching placebo. The treatment period is 8 weeks, followed by a 4-week post-treatment follow-up. To support tolerability and allow individualized treatment, study medication is started at 100 mg once daily and may be increased stepwise during follow-up contacts, based on clinical response and tolerability, up to a maximum daily dose of 300 mg. Participants assigned to placebo follow the same dosing schedule to maintain blinding.
After screening and baseline assessment, most study procedures are conducted remotely to minimize participant burden. Participants complete scheduled study assessments during treatment and follow-up and are contacted regularly by the study team to evaluate treatment response, dose adjustment, and adverse events. In addition to evaluating patient-reported outcomes related to fatigue and broader functioning, the trial includes an exploratory online effort-based decision-making task to assess motivational behaviour. Blood-based biomarker analyses will also be explored to investigate biological factors associated with fatigue and treatment response in IBD.
The placebo-controlled, double-blind design was selected because fatigue is a subjective outcome that is susceptible to placebo effects and expectation bias. This design is intended to allow a more reliable estimate of the specific treatment effect of modafinil. If modafinil is shown to be effective and well tolerated, the results of this trial may support the development of a pharmacological treatment option for an important unmet clinical need in IBD care.
- Being tested
- Modafinil, Placebo
- Keywords
- Modafinil, Inflammatory bowel disease, Crohn, Colitis, Fatigue, Remission, Pharmacological
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Colitis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Modafinil, administered orally as over-encapsulated tablets. Participants start with 100 mg once daily for the first 2 weeks. Depending on clinical response and tolerability, the dose may be increased stepwise during follow-up contacts to a maximum of 300 mg per day. Treatment duration is 8 weeks.
PlaceboDrug
Matching placebo administered orally, identical in appearance, dosing frequency, and dose-adjustment schedule to modafinil in order to maintain double blinding. Treatment duration is 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Modafinil | Active comparator | Modafinil Receives: Drug: Modafinil |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference in section I of the IBD-F questionnaire at week 8
Fatigue severity will be assessed using section I of the Inflammatory Bowel Disease-Fatigue (IBD-F) questionnaire, a patient-reported measure of fatigue in people with inflammatory bowel disease. Section I is used to assess the severity of fatigue symptoms. Scores on section I range from 0 to 20, with higher scores indicating more severe fatigue. The outcome is the between-group difference in IBD-F section I score at week 8.
Measured: at week 8 (end of treatment)
Secondary outcomes (9)
Difference in FACIT-F questionnaire
Fatigue will also be assessed using the FACIT-F questionnaire, a patient-reported measure of fatigue and its impact on daily activities and functioning. Total scores range from 0 to 52, with higher scores indicating less fatigue and better functioning. This outcome evaluates change from baseline over time.
Measured: comparing baseline with week 4, 8 and 12
Difference in section I of the IBD-F questionnaire
Section I of the IBD-F questionnaire measures severity of fatigue symptoms in people with inflammatory bowel disease. Scores range from 0 to 20, with higher scores indicating more severe fatigue. This secondary outcome evaluates change from baseline at additional time points before and after the end of treatment.
Measured: comparing baseline with week 4 and week 12
Difference in Inflammatory Bowel Disease Questionnaire (IBDQ)
Quality of life will be assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ), a disease-specific patient-reported measure covering bowel symptoms, emotional health, social function, and systemic symptoms. Total scores range from 32 to 224, with higher scores indicating better disease-related quality of life. This outcome evaluates change from baseline over time.
Measured: comparing baseline with week 4, 8 and 12
Difference in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
General health status will be assessed using the EQ-5D-5L, a standardized patient-reported measure of health-related quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher index or utility values indicate better health status. This outcome evaluates change from baseline after treatment and at follow-up.
Measured: comparing baseline with week 8 and 12
Difference in Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a patient-reported questionnaire that measures sleep quality and sleep disturbance. Total scores range from 0 to 21, with higher scores indicating worse sleep quality. This outcome evaluates change from baseline after treatment and at follow-up.
Measured: comparing baseline with week 8 and week 12
Difference in the Patient Health Questionnaire (PHQ-9)
Depressive symptoms will be assessed using the PHQ-9, a patient-reported questionnaire for the severity of depressive symptoms. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. This outcome evaluates change from baseline over time.
Measured: baseline with week 4, 8 and 12
Difference in the Generalized Anxiety Disorder Questionnaire-7 (GAD-7)
Anxiety symptoms will be assessed using the GAD-7, a patient-reported questionnaire for the severity of generalized anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. This outcome evaluates change from baseline over time.
Measured: baseline with week 4, 8 and 12
Difference in the IMTA Productivity Cost Questionnaire (iPCQ)
Productivity loss in paid work will be assessed using the IMTA Productivity Cost Questionnaire (iPCQ), a patient-reported measure of absenteeism, presenteeism, and reduced productivity related to health problems. Higher impairment values indicate greater productivity loss. This outcome evaluates change from baseline after treatment and at follow-up.
Measured: baseline with week 8 and week 12
The incidence of treatment-emergent adverse events, serious adverse events, events of clinical interest and adverse events that lead to discontinuation of modafinil use
Safety and tolerability will be assessed by recording adverse events reported during the study. Treatment-emergent adverse events are defined as adverse events occurring or worsening after the start of study treatment. Serious adverse events, events of clinical interest, and adverse events leading to permanent discontinuation of study treatment will be summarized by treatment group.
Measured: until 30 days post end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start3 Aug 2026
- Primary completion1 Feb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjolijn Duijvestein, PhD, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582458
- Sponsor's protocol ID
- MODIBD656
- Other IDs
- 2026-525163-41-00
- Acronym
- MODIFI-IBD
- Status last verified
- Apr 2026
- First submitted
- 6 May 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease: a Multicentre,Randomised, Double-blind, Placebo-controlled, Clinical Trial (MODIFI-IBD Trial)
- ClinicalTrials.gov ID
- NCT07582458
- Acronym / sponsor ID
- MODIFI-IBD / MODIBD656
- Keywords
- Modafinil, Inflammatory bowel disease, Crohn, Colitis, Fatigue, Remission, Pharmacological
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 May 2026 (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.
The goal of this clinical trial is to learn if modafinil can treat severe fatigue in adults aged 18 to 75 years with quiescent inflammatory bowel disease (IBD). The main questions it aims to answer are:
Does modafinil reduce fatigue more effectively than placebo, as measured by the mean difference in section I of the IBD-F questionnaire at week 8? Is modafinil safe and well tolerated in patients with quiescent IBD and severe fatigue?
Researchers will compare modafinil to placebo to see if modafinil improves fatigue outcomes.
Participants will:
attend one screening visit including assessment of disease activity, blood tests, stool testing, and an ECG; take modafinil or placebo for 8 weeks, starting at 100 mg daily with possible dose increases based on response and tolerability; complete online questionnaires at baseline, week 4, week 8, and week 12 about fatigue, quality of life, sleep, mood, and work productivity; be contacted regularly during the treatment period to discuss effect and side effects of the study medication; complete an online effort-based decision-making task at baseline and week 8.
Detailed description
Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is frequently associated with persistent fatigue, even during clinical remission. Fatigue is one of the most burdensome symptoms reported by patients with IBD and is associated with impaired quality of life, reduced daily functioning, and decreased work productivity. Despite its high prevalence and clinical relevance, there are currently no established pharmacological treatment options for fatigue in patients with quiescent IBD.
Modafinil is a centrally acting wakefulness-promoting agent approved for excessive daytime sleepiness in narcolepsy. It has been used for many years and has a well-characterized safety profile. Although its exact mechanism of action is not fully understood, available evidence suggests that modafinil enhances wakefulness and alertness through effects on central dopaminergic signalling. Because fatigue in IBD may involve central mechanisms related to motivation, alertness, and effort processing, modafinil is a biologically plausible candidate treatment for this population. Preliminary clinical observations have suggested that modafinil may reduce fatigue in patients with quiescent IBD, but controlled trial data are not available.
This study is a multicentre, randomized, double-blind, placebo-controlled, multicentre, clinical trial designed to evaluate the efficacy, safety, and tolerability of modafinil in adults with quiescent IBD and severe fatigue. Participants are randomized in a 1:1 ratio to receive modafinil or matching placebo. The treatment period is 8 weeks, followed by a 4-week post-treatment follow-up. To support tolerability and allow individualized treatment, study medication is started at 100 mg once daily and may be increased stepwise during follow-up contacts, based on clinical response and tolerability, up to a maximum daily dose of 300 mg. Participants assigned to placebo follow the same dosing schedule to maintain blinding.
After screening and baseline assessment, most study procedures are conducted remotely to minimize participant burden. Participants complete scheduled study assessments during treatment and follow-up and are contacted regularly by the study team to evaluate treatment response, dose adjustment, and adverse events. In addition to evaluating patient-reported outcomes related to fatigue and broader functioning, the trial includes an exploratory online effort-based decision-making task to assess motivational behaviour. Blood-based biomarker analyses will also be explored to investigate biological factors associated with fatigue and treatment response in IBD.
The placebo-controlled, double-blind design was selected because fatigue is a subjective outcome that is susceptible to placebo effects and expectation bias. This design is intended to allow a more reliable estimate of the specific treatment effect of modafinil. If modafinil is shown to be effective and well tolerated, the results of this trial may support the development of a pharmacological treatment option for an important unmet clinical need in IBD care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modafinil | Active comparator | Drug: ModafinilModafinil |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
- Age between 18 to 75 years at screening.
- ≥1 year diagnosis of IBD, based on a combination of clinical, endoscopic, histologic and radiologic criteria
- Chronic fatigue for at least six months
- Severe fatigue as confirmed with a score of ≥11 on section I of the IBD-F
Key exclusion criteria (37 listed)
- Contraindications for the use of modafinil, such as:
- Patients using medication which interacts clinically significant with modafinil, see section 3.3 'Mechanism of action \& Drug class'
- Patients using pharmacological agents with similar effects to modafinil, like central nerv-ous system (CNS) stimulants or other wakefulness-promoting drugs such as methylphenidate and amphetamines
- Surgery before or during study period that impacts ability to participate in this study, per investigator judgement
- Participation in another intervention study (excl. registries and post marketing studies)
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 |
|---|---|---|
| ModafinilModafinil, administered orally as over-encapsulated tablets. Participants start with 100 mg once daily for the first 2 weeks. Depending on clinical response and tolerability, the dose may be increased stepwise during follow-up contacts to a maximum of 300 mg per day. Treatment duration is 8 weeks. | Drug | Modafinil |
| PlaceboMatching placebo administered orally, identical in appearance, dosing frequency, and dose-adjustment schedule to modafinil in order to maintain double blinding. Treatment duration is 8 weeks. | Drug | Placebo |
Primary outcome
The mean difference in section I of the IBD-F questionnaire at week 8
Time frame: at week 8 (end of treatment)
Fatigue severity will be assessed using section I of the Inflammatory Bowel Disease-Fatigue (IBD-F) questionnaire, a patient-reported measure of fatigue in people with inflammatory bowel disease. Section I is used to assess the severity of fatigue symptoms. Scores on section I range from 0 to 20, with higher scores indicating more severe fatigue. The outcome is the between-group difference in IBD-F section I score at week 8.
9 secondary outcomes
Difference in FACIT-F questionnaire
Time frame: comparing baseline with week 4, 8 and 12
Difference in section I of the IBD-F questionnaire
Time frame: comparing baseline with week 4 and week 12
Difference in Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: comparing baseline with week 4, 8 and 12
Difference in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Time frame: comparing baseline with week 8 and 12
Difference in Pittsburgh Sleep Quality Index (PSQI)
Time frame: comparing baseline with week 8 and week 12
Difference in the Patient Health Questionnaire (PHQ-9)
Time frame: baseline with week 4, 8 and 12
Difference in the Generalized Anxiety Disorder Questionnaire-7 (GAD-7)
Time frame: baseline with week 4, 8 and 12
Difference in the IMTA Productivity Cost Questionnaire (iPCQ)
Time frame: baseline with week 8 and week 12
The incidence of treatment-emergent adverse events, serious adverse events, events of clinical interest and adverse events that lead to discontinuation of modafinil use
Time frame: until 30 days post end of treatment
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 14 Sep 2026.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Marjolijn Duijvestein, PhD, MD principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Modafinil in people with Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Chronic Fatigue, run by Radboud University Medical Center at 2 sites in Netherlands.
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 8 inclusion and 37 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 Manal Aourag, MD (+31640982958, Manal.aourag@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean difference in section I of the IBD-F questionnaire at week 8 (time frame: at week 8 (end of treatment)). 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 14 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.