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Low serine diet for Crohn's Disease

University of Michigan, Ann Arbor, MI
Crohn's DiseaseLow serine diet - DietarySupplement
Eligibility
18 - 70
All Sexes
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Study Summary

This trial is studying whether a low-serine diet can help to reduce symptoms and inflammation in Crohn's disease, as well as improve responses to the biologic therapy Ustekinumab.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 25 weeks

2 weeks
The mean C-reactive protein (CRP) at week 2 will be compared between the two groups with Student's t test.
The mean Crohn's Disease Activity Index (CDAI) scores calculated by study team at week 25 will be compared between the two groups with Student's t test
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
The mean Fecal Calprotectin (FCP) at week 2 will be compared between the two groups with Student's t test.
The mean lactulose to mannitol ratio (L/M) at week 2 will be compared between the two groups with Student's t test.
The mean lamina propria mucosa (LPM) response in stool at week 2 will be compared between the two groups with Student's t test.
The mean stool flagellin content at week 2 will be compared between the two groups with Student's t test.
25 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.
The mean CRP at week 25 will be compared between the two groups with Student's t test.
The mean FCP at week 25 will be compared between the two groups with Student's t test.
The mean L/M ratio at week 25 will be compared between the two groups with Student's t test.
The mean simple endoscopic subscore Crohn's disease (SES-CD) score at week 25 between the two treatment groups.

Trial Safety

Phase-Based Safety

1 of 3

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2
Ozanimod
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

High serine diet
1 of 2
Low serine diet
1 of 2

Experimental Treatment

10 Total Participants · 2 Treatment Groups

Primary Treatment: Low serine diet · No Placebo Group · N/A

High serine diet
DietarySupplement
Experimental Group · 1 Intervention: High serine diet · Intervention Types: DietarySupplement
Low serine diet
DietarySupplement
Experimental Group · 1 Intervention: Low serine diet · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 25 weeks

Who is running the clinical trial?

University of MichiganLead Sponsor
1,670 Previous Clinical Trials
6,421,625 Total Patients Enrolled
Kenneth Rainin FoundationUNKNOWN
Peter D Higgins, MDPrincipal InvestigatorUniversity of Michigan

Eligibility Criteria

Age 18 - 70 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Is there still space available for individuals to join this experiment?

"Clinicaltrials.gov shows that this medical trial is accepting participants, having first been posted on March 18th 2021 and last updated May 19th 2022." - Anonymous Online Contributor

Unverified Answer

Am I eligible to participate in this experiment?

"This trial is seeking 10 individuals between the ages of 18-70 who are living with ileocolitis to participate." - Anonymous Online Contributor

Unverified Answer

Does this research endeavor include participants aged 70 and above?

"This medical study will include those aged 18 and above, with a cut-off of 70 years old." - Anonymous Online Contributor

Unverified Answer

What is the maximum capacity of participants for this research trial?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this research endeavour, which was first launched on March 18th 2021, is actively recruiting patients. Specifically, the study seeks 10 individuals from a single medical centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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