Reduction of Intestinal Inflammatory ActivityNCT05867537
Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD
A study testing Gluten-free diet in people with Reduction of Intestinal Inflammatory Activity, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The objective of this clinical study is to demonstrate efficacy and feasibility of a long-term dietary intervention to modify intestinal inflammation in high-risk patient cohorts. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Reduction of Intestinal Inflammatory Activity
- What is being tested?
- Gluten-free diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2023to Jan 2028
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of UC, CD or PSC-IBD
- Willingness, to follow a gluten-free diet for 78 weeks
- Stable therapeutic treatment for more 8 weeks
- For CD: Harvey Bradshaw index (HBI) of more 5 points, corresponding to a minimum of mild intestinal inflammation in CD
- For UC: Mayo Score of more 2 points, corresponding to a minimum of mild intestinal inflammation in UC
- Patient signed informed consent
Who cannot join
- Antibiotics during last 4 weeks
- Intake of probiotics
- Gluten-free diet is already practiced
- Concomitant diagnosis of celiac disease
- Positive serology for transglutaminase IgA / IgG antibody or deamidated gliadin IgA / IgG
- Breast feeding
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this clinical study is to demonstrate efficacy and feasibility of a long-term dietary intervention to modify intestinal inflammation in high-risk patient cohorts. To this end a 78 weeks wheat protein-free diet will be administered in patients with inflammatory bowel disease (IBD) with and without associated primary sclerosing cholangitis (PSC-IBD).
- Being tested
- Gluten-free diet
- Keywords
- IBD, PSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten-free dietDietary supplement
Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).
| Study group | Role | What they receive |
|---|---|---|
| Gluten-free diet in Crohn disease | Active comparator | Not described Receives: Dietary Supplement: Gluten-free diet |
| Gluten-free diet in ulcerative colitis | Active comparator | Not described Receives: Dietary Supplement: Gluten-free diet |
| Gluten-free diet in Primary sclerosing cholangitis | Active comparator | Not described Receives: Dietary Supplement: Gluten-free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical and endoscopic parameters of intestinal inflammation following 78 weeks of long-term gluten free dietary intervention, compared to pre-interventional levels in crohn´s disease (CD)
Change of Harvey bradshaw index (HBI) for CD following 78 weeks of long-term gluten free dietary intervention. HBI range from 0 to 18 points + number of daily liquid stools (remission: HBI < 5, active disease: HBI ≥ 5, severe disease: HBI ≥ 8)
Measured: 78 Weeks + 12 Month follow-up
Change in clinical and endoscopic parameters of intestinal inflammation following 78 weeks of long-term gluten free dietary intervention, compared to pre-interventional levels in ulcerative colitis (UC) and PSC-IBD
Change of partial Mayo Score (pMS) for UC and PSC-IBD following 78 weeks of long-term gluten free dietary intervention. pMS range from 0 to 12 points (remission: pMS < 2, mild activity: pMS 2-4, moderate activity: pMS 5-7, severe activity: pMS > 7).
Measured: 78 Weeks + 12 Month follow-up
Secondary outcomes (4)
The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of TNF-alpha of the intestine in IBD patients
Changes between baseline and end of dietary period in TNF-alpha of mucosal transcript profiles.
Measured: 78 Weeks + 12 Month follow-up
The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-10 of the intestine in IBD patients
Changes between baseline and end of dietary period in IL-10 mucosal transcript profiles.
Measured: 78 Weeks + 12 Month follow-up
The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-6 of the intestine in IBD patients
Changes between baseline and end of dietary period in IL-6 mucosal transcript profiles.
Measured: 78 Weeks + 12 Month follow-up
Long-term dietary influence on intestinal microbiome in IBD patient cohorts
Changes between baseline and end of dietary period in luminal microbiome dynamics from faecal samples identified by 16S RNA sequencing.
Measured: 78 Weeks + 12 Month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start18 Jan 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction of Intestinal Inflammatory ActivityStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein, Lithuanian University of Health Sciences, University Medical Center Groningen, Netherland, Weizmann Institute of Science, Israel, Catholic University of the Sacred Heart, Eurice European Research and project office GMBH, Germany, Orebro University, Sweden, Region Capital Denmark, European Federation of Crohn´s and Ulcerative Colitis Associations, Belgium
- Responsible party
- Principal investigator, Samuel Huber, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867537
- Sponsor's protocol ID
- miGut Health
- Status last verified
- Dec 2024
- First submitted
- 3 Apr 2023
- Last updated
- 30 Mar 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD
- ClinicalTrials.gov ID
- NCT05867537
- Acronym / sponsor ID
- miGut Health
- Keywords
- IBD, PSC
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein, Lithuanian University of Health Sciences, University Medical Center Groningen, Netherland, Weizmann Institute of Science, Israel, Catholic University of the Sacred Heart, Eurice European Research and project office GMBH, Germany, Orebro University, Sweden, Region Capital Denmark, European Federation of Crohn´s and Ulcerative Colitis Associations, Belgium
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 22 May 2023 (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 objective of this clinical study is to demonstrate efficacy and feasibility of a long-term dietary intervention to modify intestinal inflammation in high-risk patient cohorts. To this end a 78 weeks wheat protein-free diet will be administered in patients with inflammatory bowel disease (IBD) with and without associated primary sclerosing cholangitis (PSC-IBD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gluten-free diet in Crohn disease | Active comparator | Dietary Supplement: Gluten-free diet |
| Gluten-free diet in ulcerative colitis | Active comparator | Dietary Supplement: Gluten-free diet |
| Gluten-free diet in Primary sclerosing cholangitis | Active comparator | Dietary Supplement: Gluten-free diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of UC, CD or PSC-IBD
- Willingness, to follow a gluten-free diet for 78 weeks
- Stable therapeutic treatment for more 8 weeks
- For CD: Harvey Bradshaw index (HBI) of more 5 points, corresponding to a minimum of mild intestinal inflammation in CD
- For UC: Mayo Score of more 2 points, corresponding to a minimum of mild intestinal inflammation in UC
Key exclusion criteria (7 listed)
- Antibiotics during last 4 weeks
- Intake of probiotics
- Gluten-free diet is already practiced
- Concomitant diagnosis of celiac disease
- Positive serology for transglutaminase IgA / IgG antibody or deamidated gliadin IgA / IgG
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 |
|---|---|---|
| Gluten-free dietImplementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD). | Dietary supplement | Gluten-free diet in Crohn disease, Gluten-free diet in Primary sclerosing cholangitis, Gluten-free diet in ulcerative colitis |
Primary outcome
Change in clinical and endoscopic parameters of intestinal inflammation following 78 weeks of long-term gluten free dietary intervention, compared to pre-interventional levels in crohn´s disease (CD)
Time frame: 78 Weeks + 12 Month follow-up
Change of Harvey bradshaw index (HBI) for CD following 78 weeks of long-term gluten free dietary intervention. HBI range from 0 to 18 points + number of daily liquid stools (remission: HBI < 5, active disease: HBI ≥ 5, severe disease: HBI ≥ 8)
Change in clinical and endoscopic parameters of intestinal inflammation following 78 weeks of long-term gluten free dietary intervention, compared to pre-interventional levels in ulcerative colitis (UC) and PSC-IBD
Time frame: 78 Weeks + 12 Month follow-up
Change of partial Mayo Score (pMS) for UC and PSC-IBD following 78 weeks of long-term gluten free dietary intervention. pMS range from 0 to 12 points (remission: pMS < 2, mild activity: pMS 2-4, moderate activity: pMS 5-7, severe activity: pMS > 7).
4 secondary outcomes
The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of TNF-alpha of the intestine in IBD patients
Time frame: 78 Weeks + 12 Month follow-up
The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-10 of the intestine in IBD patients
Time frame: 78 Weeks + 12 Month follow-up
The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-6 of the intestine in IBD patients
Time frame: 78 Weeks + 12 Month follow-up
Long-term dietary influence on intestinal microbiome in IBD patient cohorts
Time frame: 78 Weeks + 12 Month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten-free diet in people with Reduction of Intestinal Inflammatory Activity, run by Universitätsklinikum Hamburg-Eppendorf at 1 site 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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical and endoscopic parameters of intestinal inflammation following 78 weeks of long-term gluten free dietary intervention, compared to pre-interventional levels in crohn´s disease (CD) (time frame: 78 Weeks + 12 Month follow-up). 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 30 Mar 2025.