Microbiome Modification to Enhance Stelara Response in Crohn's Disease

Not Applicable

Withdrawn

• Conditions: Crohn Disease
• Interventions: Dietary Supplement: High serine diet; Dietary Supplement: Low serine diet

• Registration Number: NCT04795960
• Lead Sponsor: University of Michigan

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-12
• Study Start: 2021-03-18
• Primary Completion: 2023-03
• Study Completion: 2023-03
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High serine diet	High serine diet	-
Low serine diet	Low serine diet	-

Primary Outcome Measures

Name	Time	Method
The mean simple endoscopic subscore Crohn's disease (SES-CD) score at week 25 between the two treatment groups.	25 weeks	This will be calculated by endoscopist at week 25.

Secondary Outcome Measures

Name	Time	Method
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	2 weeks	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.
The mean CD-PRO scores calculated by study team at week 25 will be compared between the two groups with Student's t test.	25 weeks	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States