Microbiome Modification to Enhance Stelara Response in Crohn's Disease (MIM-TESRIC)

  • STATUS
    Recruiting
  • days left to enroll
    90
  • participants needed
    10
  • sponsor
    University of Michigan
Updated on 3 June 2022
prednisone
ustekinumab
crohn's disease

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. a high serine diet) will improve responses in patients initiating therapy with Ustekinumab (Stelara), an FDA-approved biologic therapy for Crohn's disease.

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.

Details
Condition Crohn Disease
Treatment Low serine diet, High serine diet
Clinical Study IdentifierNCT04795960
SponsorUniversity of Michigan
Last Modified on3 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note