Crohn DiseaseMIM-TESRICNCT04795960
Microbiome Modification to Enhance Stelara Response in Crohn's Disease
A study testing Low serine diet and High serine diet in people with Crohn Disease, run by University of Michigan at 1 site in United States.
Trial summary
This pilot study is being completed to determine whether a low-serine diet vs a high serine diet will reduce inflammation and symptoms in Crohn's disease (CD), as well as determine whether a low-serine diet (vs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Low serine diet and High serine diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to Mar 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Crohn's Disease (CD) for at least 3 months prior to baseline. Appropriate documentation of biopsy results consistent with the diagnosis of CD, as determined by the investigator.
- Simple endoscopic subscore Crohn's disease (SES-CD) ≥ 7 for ileocolonic CD (or >=4 if only ileal CD) as confirmed by Dr. Higgins' scoring of colonoscopy.
- Are scheduled to begin Ustekinumab within the next 7-60 days
- Must be scheduled for clinically indicated colonoscopy, ordered by primary Gastroenterologist physician, and covered by insurance
- Must have access to a computer capable of completing video visits
- Must be willing to follow assigned meat-free diet provided by the study exclusively for 2 weeks
- Patients on anti-diarrheals must be on a stable dose for at least 2 weeks
- Prednisone is allowed up to a daily dose of 20 mg, with a stable dose for at least 1 week
Who cannot join
- Subject with a current diagnosis of Ulcerative Colitis
- Subjects requiring or receiving any Total Parenteral Nutrition (TPN) and/or exclusive enteral nutrition.
- Subjects who are pregnant or plan to become pregnant over the duration of the study
- Antibiotics in the previous 2 weeks.
- Probiotics in the previous 2 weeks.
- Ongoing therapy with infliximab, adalimumab, certolizumab, vedolizumab, or tofacitinib, is not allowed - must stop at least 1 week prior to ustekinumab start.
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- Changes in dose of 5-aminosalicylates within the past 1 week - must be on a stable dose for at least one week.
- Changes in dose of immunomodulators (including Azathioprine, 6-mercaptopurine, methotrexate) within the past 4 weeks - must be on a stable dose for 4 weeks.
- Subjects with the following known complications of CD; Toxic megacolon, Short bowel syndrome or short gut (less than 100 centimeters, Ostomy, Symptomatic bowel strictures (scope cannot be passed through), any diagnosis that could interfere with nutrient absorption, note that actively draining fistulas are allowed at entry.
- Diabetes
- Subjects who use dietary supplements such as liquid or powder protein drinks/shakes, meal replacement shakes, and fiber supplements, etc. must be willing to stop at least 24 hours prior to starting the assigned diet
- Known allergy to soy products
- Oral Iron must be stopped at least 24 hours prior to baseline
- For severe anemia, intravenous (IV) iron can replace oral iron if approved and ordered by the prescribing physician
- Any subject currently hospitalized
- Any subject with a positive Clostridium difficile test (within 30 days of baseline) or currently being treated for Clostridium difficile.
- History of clinically significant medical condition or any other reason which, in the opinion of the PI, would interfere with the subject's participation
- Any active, chronic or recurrent infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study is being completed to determine whether a low-serine diet vs a high serine diet will reduce inflammation and symptoms in Crohn's disease (CD), as well as determine whether a low-serine diet (vs. a high serine diet) will improve responses in patients initiating therapy with Ustekinumab (Stelara), an FDA-approved biologic therapy for Crohn's disease.
Read the detailed description
Eligible participants that will be given Ustekinumab as part of their standard of care will be enrolled in this study.
The study hypotheses include that a low serine diet (compared to a high serine diet) in patients with active CD will:
- Reduce the relative abundance of Adherent invasive ecoli (AIEC), and increase the relative abundance of Bacteroides and Faecalibacterium in stool of patients with Crohn's disease.
- Make patients more likely to respond to ustekinumab (anti-Interleukin12/23) therapy with control of inflammation as measured by the mean Simple endoscopic subscore Crohn's disease (SES-CD) in each group at week 25.
- Conditions
- Crohn Disease
- Being tested
- Low serine diet, High serine diet
- Keywords
- Ustekinumab, Stelara, Diet, Crohn's
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low serine dietDietary supplement
Participants will be on this diet 1 week prior to initiation and 1 week after initiation of Ustekinumab (standard of care medication). The meals will be prepared in the Michigan Clinical Research Unit (MCRU) at the University of Michigan Health System and given to the participants.
High serine dietDietary supplement
Participants will be on this diet 1 week prior to initiation and 1 week after initiation of Ustekinumab (standard of care medication). The meals will be prepared in the Michigan Clinical Research Unit (MCRU) at the University of Michigan Health System and given to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Low serine diet | Experimental | Not described Receives: Dietary Supplement: Low serine diet |
| High serine diet | Experimental | Not described Receives: Dietary Supplement: High serine diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean simple endoscopic subscore Crohn's disease (SES-CD) score at week 25 between the two treatment groups.
This will be calculated by endoscopist at week 25.
Measured: 25 weeks
Secondary outcomes (2)
The mean Crohn's disease patient report outcomes (CD-PRO) score at week 2 will be compared between the two groups with Student's t test
There are a series of 52 questions to measure the extent of participant's crohn's disease. The higher the score the worse the disease.
Measured: 2 weeks
The mean CD-PRO scores calculated by study team at week 25 will be compared between the two groups with Student's t test.
There are a series of 52 questions to measure the extent of participant's crohn's disease. The higher the score the worse the disease.
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start18 Mar 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: Lack of eligible and interested patients
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.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Kenneth Rainin Foundation
- Responsible party
- Principal investigator, Peter Higgins, University of Michigan
- Investigators
- Peter D Higgins, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795960
- Sponsor's protocol ID
- HUM00185677
- Acronym
- MIM-TESRIC
- Status last verified
- Jun 2023
- First submitted
- 9 Mar 2021
- Last updated
- 12 Jun 2023
- Results posted
- 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 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Modification to Enhance Stelara Response in Crohn's Disease
- ClinicalTrials.gov ID
- NCT04795960
- Acronym / sponsor ID
- MIM-TESRIC / HUM00185677
- Conditions
- Crohn Disease
- Keywords
- Ustekinumab, Stelara, Diet, Crohn's
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of eligible and interested patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Kenneth Rainin Foundation
- Study start
- 18 Mar 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 12 Mar 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.
This pilot study is being completed to determine whether a low-serine diet vs a high serine diet will reduce inflammation and symptoms in Crohn's disease (CD), as well as determine whether a low-serine diet (vs. a high serine diet) will improve responses in patients initiating therapy with Ustekinumab (Stelara), an FDA-approved biologic therapy for Crohn's disease.
Detailed description
Eligible participants that will be given Ustekinumab as part of their standard of care will be enrolled in this study.
The study hypotheses include that a low serine diet (compared to a high serine diet) in patients with active CD will:
- Reduce the relative abundance of Adherent invasive ecoli (AIEC), and increase the relative abundance of Bacteroides and Faecalibacterium in stool of patients with Crohn's disease.
- Make patients more likely to respond to ustekinumab (anti-Interleukin12/23) therapy with control of inflammation as measured by the mean Simple endoscopic subscore Crohn's disease (SES-CD) in each group at week 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low serine diet | Experimental | Dietary Supplement: Low serine diet |
| High serine diet | Experimental | Dietary Supplement: High serine diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed diagnosis of Crohn's Disease (CD) for at least 3 months prior to baseline. Appropriate documentation of biopsy results consistent with the diagnosis of CD, as determined by the investigator.
- Simple endoscopic subscore Crohn's disease (SES-CD) ≥ 7 for ileocolonic CD (or >=4 if only ileal CD) as confirmed by Dr. Higgins' scoring of colonoscopy.
- Are scheduled to begin Ustekinumab within the next 7-60 days
- Must be scheduled for clinically indicated colonoscopy, ordered by primary Gastroenterologist physician, and covered by insurance
- Must have access to a computer capable of completing video visits
Key exclusion criteria (18 listed)
- Subject with a current diagnosis of Ulcerative Colitis
- Subjects requiring or receiving any Total Parenteral Nutrition (TPN) and/or exclusive enteral nutrition.
- Subjects who are pregnant or plan to become pregnant over the duration of the study
- Antibiotics in the previous 2 weeks.
- Probiotics in the previous 2 weeks.
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 |
|---|---|---|
| Low serine dietParticipants will be on this diet 1 week prior to initiation and 1 week after initiation of Ustekinumab (standard of care medication). The meals will be prepared in the Michigan Clinical Research Unit (MCRU) at the University of Michigan Health System and given to the participants. | Dietary supplement | Low serine diet |
| High serine dietParticipants will be on this diet 1 week prior to initiation and 1 week after initiation of Ustekinumab (standard of care medication). The meals will be prepared in the Michigan Clinical Research Unit (MCRU) at the University of Michigan Health System and given to the participants. | Dietary supplement | High serine diet |
Primary outcome
The mean simple endoscopic subscore Crohn's disease (SES-CD) score at week 25 between the two treatment groups.
Time frame: 25 weeks
This will be calculated by endoscopist at week 25.
2 secondary outcomes
The mean Crohn's disease patient report outcomes (CD-PRO) score at week 2 will be compared between the two groups with Student's t test
Time frame: 2 weeks
The mean CD-PRO scores calculated by study team at week 25 will be compared between the two groups with Student's t test.
Time frame: 25 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- 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.
Peter D Higgins, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low serine diet and High serine diet in people with Crohn Disease, run by University of Michigan at 1 site in United States.
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 18 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: withdrawn, as of the sponsor's last update on 12 Jun 2023. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
The mean simple endoscopic subscore Crohn's disease (SES-CD) score at week 25 between the two treatment groups. (time frame: 25 weeks). 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 12 Jun 2023.