Microbiome Modification to Enhance Stelara Response in Crohn's Disease

NCT04795960 | Withdrawn

• 1 other identifier: HUM00185677
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Keywords

Ustekinumab; Stelara; Diet; Crohn's

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

  25 weeks

Other Outcomes (9)

• The mean stool flagellin content at week 2 will be compared between the two groups with Student's t test.

  2 weeks

• The mean lamina propria mucosa (LPM) response in stool at week 2 will be compared between the two groups with Student's t test.

  2 weeks

• The mean C-reactive protein (CRP) at week 2 will be compared between the two groups with Student's t test.

  2 weeks

Study Arms (2)

Low serine diet

EXPERIMENTAL

Dietary Supplement: Low serine diet

High serine diet

EXPERIMENTAL

Dietary Supplement: High serine diet

Interventions

Low serine diet DIETARY_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.

Low serine diet

High serine diet DIETARY_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 diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Kenneth Rainin Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Peter D Higgins, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: March 18, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)