IBD (Inflammatory Bowel Disease)OPTIVIRNCT07240181
OPTImization of Inflammatory Bowel Disease Treatment Through Understanding of Gut VIRome Heterogeneity
An observational study of IBD (Inflammatory Bowel Disease) and Crohns Disease, run by Andreas Munk Petersen at 1 site in Denmark.
Trial summary
Title: The Role of Good Viruses in Inflammatory Bowel Disease Background An imbalance in the bacteria in the gut - called gut dysbiosis - is linked to chronic bowel diseases such as Crohn's disease and ulcerative colitis (IBD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBD (Inflammatory Bowel Disease), Crohns Disease, Colitis Ulcerative
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2025to 31 Dec 2029
- How long will I take part?
- 1 Month
- 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: The study is a non-interventional trial aiming to examine the virome/bacteriophages from stool samples of patients with IBD (UC, CD, and PSC-IBD) and compare these with healthy controls (fecal donors). Study participants The study will include 30 patients with IBD: 10 with ulcerative colitis (UC), 10 with Crohn's disease (CD), and 10 with PSC-IBD. In each subgroup, 5 participants with active disease and 5 in remission will be included (active disease is defined as fecal calprotectin > 250). In addition, 10 fecal donors will be included as healthy controls.
Who may be able to join
- Confirmed diagnosis of UC, CD, or PSC-IBD for at least 6 months
- Age ≥ 18 years
- Stable medical treatment for IBD (and PSC-IBD) within the past 3 months
- Stable lifestyle within the past month (including diet, exercise, and sleep habits)
- Verbal and written informed consent
Who cannot join
- Use of antibiotics within the past 3 months
- Pregnancy or breastfeeding
- Substance abuse or excessive alcohol consumption (according to Danish Health Authority guidelines)
- Other known comorbidities that may affect the gut microbiome (e.g., type 1 diabetes, other autoimmune diseases, cancer, severe obesity, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Hvidovre Hospital
Hvidovre, 2650
Andreas M. Petersen, Professor, +4538626199, Andreas.Munk.Petersen@regionh.dk
About this study
Official title: Optimization of Inflammatory Bowel Disease Treatment Through Understanding of Gut Virome Heterogeneity and the Potential for Bacteriophage-based Therapy
Title: The Role of Good Viruses in Inflammatory Bowel Disease
Background An imbalance in the bacteria in the gut - called gut dysbiosis - is linked to chronic bowel diseases such as Crohn's disease and ulcerative colitis (IBD). A special and more severe form of IBD, called primary sclerosing cholangitis-associated IBD (PSC-IBD), affects both the gut and the bile ducts, and in serious cases can lead to liver failure. There is currently no cure for IBD.
Read more
Research suggests that microorganisms in the gut, especially bacteria and viruses called bacteriophages, play an important role in how the disease develops. Treatment with stool from healthy donors, known as fecal microbiota transplantation (FMT), has proven effective against certain infections and has shown promising results in IBD. A newer and possibly safer method is fecal virome transplantation (FVT), where only the virus part (the gut virome) of the stool is used.
Bacteriophages can kill harmful bacteria and help restore balance in the gut, but their use is still experimental. Therefore, we aim to develop a new treatment by growing bacteriophages from healthy individuals in the lab and using them to restore a healthy balance of bacteria and viruses in the gut of patients with IBD.
Purpose of the study The long-term goal of the study is to improve treatment for IBD by gaining a better understanding of differences in the gut virome between IBD patients and healthy people. We also want to explore whether "fermented" bacteriophages from donor stool can be developed into a future bacteriophage-based therapy.
This will be studied using experimental lab setups and animal models. The study will include 10 healthy stool donors and 30 IBD patients (10 with ulcerative colitis, 10 with Crohn's disease, and 10 with PSC-IBD). The study does not involve any treatments - only the collection of biological samples and access to information about your health from your medical record.
- Keywords
- Bacteriophages, Gut virome, Bacteriophage therapy, Fecal virome transplantation, Fecal filtrate transplantation, Gut microbiome imbalances
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis (UC) | * Confirmed diagnosis of UC for at least 6 months * Age ≥ 18 years * Stable medical treatment for IBD during the past 3 months * Stable lifestyle within the past month (including diet, physical activity, and sleep habits) * Verbal and written informed consent | |
| Crohns disease (CD) | * Confirmed diagnosis of CD for at least 6 months * Age ≥ 18 years * Stable medical treatment for IBD during the past 3 months * Stable lifestyle within the past month (including diet, physical activity, and sleep habits) * Verbal and written informed consent | |
| Primary Sclerosing Cholangitis and Inflammatory Bowel Disease (PSC-IBD) | * Confirmed diagnosis of PSC-IBD for at least 6 months * Age ≥ 18 years * Stable medical treatment for PSC-IBD during the past 3 months * Stable lifestyle within the past month (including diet, physical activity, and sleep habits) * Verbal and written informed consent | |
| Healthy controls (fecal donors) | Donors who are already part of the existing donor program at the Department of Infectious Diseases, Hvidovre Hospital, will serve as healthy controls. Verbal and written informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize gut bacteriophages and bacteria in patients with IBD and in healthy controls (fecal donors), both as before and after fermentation in bioreactors
16S rRNA gene and metagenome sequencing
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Andreas Munk Petersen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor-investigator, Andreas Munk Petersen, Hvidovre University Hospital
- Investigators
- Sofie I Halkjær, PhD, Principal investigator, Hvidovre University HospitalTorben S Rasmussen, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240181
- Sponsor's protocol ID
- H-25044017
- Acronym
- OPTIVIR
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Inflammatory Bowel Disease Treatment Through Understanding of Gut Virome Heterogeneity and the Potential for Bacteriophage-based Therapy
- ClinicalTrials.gov ID
- NCT07240181
- Acronym / sponsor ID
- OPTIVIR / H-25044017
- Keywords
- Bacteriophages, Gut virome, Bacteriophage therapy, Fecal virome transplantation, Fecal filtrate transplantation, Gut microbiome imbalances
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Andreas Munk PetersenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Nov 2025 (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.
Title: The Role of Good Viruses in Inflammatory Bowel Disease
Background An imbalance in the bacteria in the gut - called gut dysbiosis - is linked to chronic bowel diseases such as Crohn's disease and ulcerative colitis (IBD). A special and more severe form of IBD, called primary sclerosing cholangitis-associated IBD (PSC-IBD), affects both the gut and the bile ducts, and in serious cases can lead to liver failure. There is currently no cure for IBD.
Research suggests that microorganisms in the gut, especially bacteria and viruses called bacteriophages, play an important role in how the disease develops. Treatment with stool from healthy donors, known as fecal microbiota transplantation (FMT), has proven effective against certain infections and has shown promising results in IBD. A newer and possibly safer method is fecal virome transplantation (FVT), where only the virus part (the gut virome) of the stool is used.
Bacteriophages can kill harmful bacteria and help restore balance in the gut, but their use is still experimental. Therefore, we aim to develop a new treatment by growing bacteriophages from healthy individuals in the lab and using them to restore a healthy balance of bacteria and viruses in the gut of patients with IBD.
Purpose of the study The long-term goal of the study is to improve treatment for IBD by gaining a better understanding of differences in the gut virome between IBD patients and healthy people. We also want to explore whether "fermented" bacteriophages from donor stool can be developed into a future bacteriophage-based therapy.
This will be studied using experimental lab setups and animal models. The study will include 10 healthy stool donors and 30 IBD patients (10 with ulcerative colitis, 10 with Crohn's disease, and 10 with PSC-IBD). The study does not involve any treatments - only the collection of biological samples and access to information about your health from your medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis (UC) | – | –* Confirmed diagnosis of UC for at least 6 months * Age ≥ 18 years * Stable medical treatment for IBD during the past 3 months * Stable lifestyle within the past month (including diet, physical activity, and sleep habits) * Verbal and written informed consent |
| Crohns disease (CD) | – | –* Confirmed diagnosis of CD for at least 6 months * Age ≥ 18 years * Stable medical treatment for IBD during the past 3 months * Stable lifestyle within the past month (including diet, physical activity, and sleep habits) * Verbal and written informed consent |
| Primary Sclerosing Cholangitis and Inflammatory Bowel Disease (PSC-IBD) | – | –* Confirmed diagnosis of PSC-IBD for at least 6 months * Age ≥ 18 years * Stable medical treatment for PSC-IBD during the past 3 months * Stable lifestyle within the past month (including diet, physical activity, and sleep habits) * Verbal and written informed consent |
| Healthy controls (fecal donors) | – | –Donors who are already part of the existing donor program at the Department of Infectious Diseases, Hvidovre Hospital, will serve as healthy controls. Verbal and written informed consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is a non-interventional trial aiming to examine the virome/bacteriophages from stool samples of patients with IBD (UC, CD, and PSC-IBD) and compare these with healthy controls (fecal donors). Study participants The study will include 30 patients with IBD: 10 with ulcerative colitis (UC), 10 with Crohn's disease (CD), and 10 with PSC-IBD. In each subgroup, 5 participants with active disease and 5 in remission will be included (active disease is defined as fecal calprotectin > 250). In addition, 10 fecal donors will be included as healthy controls.
Key inclusion criteria (5 listed)
- Confirmed diagnosis of UC, CD, or PSC-IBD for at least 6 months
- Age ≥ 18 years
- Stable medical treatment for IBD (and PSC-IBD) within the past 3 months
- Stable lifestyle within the past month (including diet, exercise, and sleep habits)
- Verbal and written informed consent
Key exclusion criteria (4 listed)
- Use of antibiotics within the past 3 months
- Pregnancy or breastfeeding
- Substance abuse or excessive alcohol consumption (according to Danish Health Authority guidelines)
- Other known comorbidities that may affect the gut microbiome (e.g., type 1 diabetes, other autoimmune diseases, cancer, severe obesity, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To characterize gut bacteriophages and bacteria in patients with IBD and in healthy controls (fecal donors), both as before and after fermentation in bioreactors
Time frame: 3 years
16S rRNA gene and metagenome sequencing
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 20 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Sofie I Halkjær, PhD principal investigator
Hvidovre University Hospital
Torben S Rasmussen, PhD principal investigator
University of Copenhagen
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 IBD (Inflammatory Bowel Disease) and Crohns Disease, run by Andreas Munk Petersen at 1 site in Denmark.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 Nov 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 Denmark. 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 Andreas M Petersen, Professor (+4538626199, andreas.munk.petersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize gut bacteriophages and bacteria in patients with IBD and in healthy controls (fecal donors), both as before and after fermentation in bioreactors (time frame: 3 years). 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 20 Nov 2025.