Reduction of Intestinal Inflammatory ActivityPSt-GFDNCT04006886
Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC)
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
Gluten is a protein found in wheat and other cereals as barley and rye. It triggers an inflammatory reaction in the small-bowel of genetically predisposed persons. Alpha-amylase/trypsin inhibitors (ATIs) of wheat seem to be the responsible trigger of this intestinal Inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Reduction of Intestinal Inflammatory Activity
- What is being tested?
- Gluten-free diet
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jul 2017to 1 Jul 2019
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.
Who cannot join
- patients with coeliac disease or wheat allergy
- patients with active colitis
- patients already on gluten-free diet
- liver transplanted patients
- patients also diagnosed with autoimmune hepatites (PSC-AIH overlap)
- coloscopy within 2 months before study
- Endoscopic retrograde cholangiopancreatography (ERCP) within 3 months before study
- antibiotics within 3 month before study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-Study
Gluten is a protein found in wheat and other cereals as barley and rye. It triggers an inflammatory reaction in the small-bowel of genetically predisposed persons. Alpha-amylase/trypsin inhibitors (ATIs) of wheat seem to be the responsible trigger of this intestinal Inflammation.
Intestinal inflammation is connected to other extra-intestinal autoimmune inflammations like PSC (as f.ex. the association of PSC with inflammatory bowel disease proves).
Read more
Hypothesis: Avoidance of ATIs through a gluten-free diet will reduce intestinal inflammation and thus also the the inflammatory activity in the liver.
Proof of hypothesis:
- Pilot study with n=20 patients with PSC
- Explorative, open-label, mono-centric study
- Inclusion criteria: age 18-65, diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.
- Being tested
- Gluten-free diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten-free dietDietary supplement
After run-in phase with normal diet under Observation, patients will be on a gluten-free diet for two months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of intestinal inflammatory activity
Expression of pro-inflammatory cytokines in gut mucosa (Sigma)
Measured: 2 months
Secondary outcomes (5)
Inflammatory activity of the liver
alkaline phosphatase (AP)
Measured: 2 months
Reduction of inflammatory cells/markers in the blood
stored blood samples, Pax-Gene
Measured: 2 months
Quality of life
questionnaire
Measured: 2 months
Change of symptoms with change of diet.
questionnaire
Measured: 2 months
Changes in patients microbiota
stool samples
Measured: 2 months (5 months with follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start11 Jul 2017
- Primary completion9 May 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel, Johannes Gutenberg University Mainz
- Responsible party
- Principal investigator, Marcus Tetzlaff, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006886
- Sponsor's protocol ID
- PSt-GFD
- Acronym
- PSt-GFD
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liwinski T, Hubener S, Henze L, Hubener P, Heinemann M, Tetzlaff M, Hiller MI, Jagemann B, Surabattula R, Leeming D, Karsdal M, Monguzzi E, Schachschal G, Rosch T, Bang C, Franke A, Lohse AW, Schuppan D, Schramm C. A prospective pilot study of a gluten-free diet for primary sclerosing cholangitis and associated colitis. Aliment Pharmacol Ther. 2023 Jan;57(2):224-236. doi: 10.1111/apt.17256. Epub 2022 Oct 20.
PubMed 36266939
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-Study
- ClinicalTrials.gov ID
- NCT04006886
- Acronym / sponsor ID
- PSt-GFD / PSt-GFD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel, Johannes Gutenberg University Mainz
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 5 Jul 2019 (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.
Gluten is a protein found in wheat and other cereals as barley and rye. It triggers an inflammatory reaction in the small-bowel of genetically predisposed persons. Alpha-amylase/trypsin inhibitors (ATIs) of wheat seem to be the responsible trigger of this intestinal Inflammation.
Intestinal inflammation is connected to other extra-intestinal autoimmune inflammations like PSC (as f.ex. the association of PSC with inflammatory bowel disease proves).
Hypothesis: Avoidance of ATIs through a gluten-free diet will reduce intestinal inflammation and thus also the the inflammatory activity in the liver.
Proof of hypothesis:
- Pilot study with n=20 patients with PSC
- Explorative, open-label, mono-centric study
- Inclusion criteria: age 18-65, diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.
Key exclusion criteria (8 listed)
- patients with coeliac disease or wheat allergy
- patients with active colitis
- patients already on gluten-free diet
- liver transplanted patients
- patients also diagnosed with autoimmune hepatites (PSC-AIH overlap)
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 dietAfter run-in phase with normal diet under Observation, patients will be on a gluten-free diet for two months. | Dietary supplement | – |
Primary outcome
Reduction of intestinal inflammatory activity
Time frame: 2 months
Expression of pro-inflammatory cytokines in gut mucosa (Sigma)
5 secondary outcomes
Inflammatory activity of the liver
Time frame: 2 months
Reduction of inflammatory cells/markers in the blood
Time frame: 2 months
Quality of life
Time frame: 2 months
Change of symptoms with change of diet.
Time frame: 2 months
Changes in patients microbiota
Time frame: 2 months (5 months with follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 36266939Liwinski T, Hubener S, Henze L, Hubener P, Heinemann M, Tetzlaff M, Hiller MI, Jagemann B, Surabattula R, Leeming D, Karsdal M, Monguzzi E, Schachschal G, Rosch T, Bang C, Franke A, Lohse AW, Schuppan D, Schramm C. A prospective pilot study of a gluten-free diet for primary sclerosing cholangitis and associated colitis. Aliment Pharmacol Ther. 2023 Jan;57(2):224-236. doi: 10.1111/apt.17256. Epub 2022 Oct 20.
- 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. 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 5 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of intestinal inflammatory activity (time frame: 2 months). 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 NCT04006886, which also lists 1 linked publication.
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 5 Jul 2019.