Low serine diet for Ileocolitis

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MI
Ileocolitis
Low serine diet - DietarySupplement
Eligibility
18+
All Sexes
Eligible conditions
Ileocolitis

Study Summary

This study is evaluating whether a low-serine diet may help reduce inflammation and symptoms in Crohn's disease.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Low serine diet will improve 1 primary outcome, 2 secondary outcomes, and 9 other outcomes in patients with Ileocolitis. Measurement will happen over the course of 2 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

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
Low serine diet

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. Low Serine Diet is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Low serine diet
DietarySupplement
High serine diet
DietarySupplement

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 25 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 25 weeks for reporting.

Who is running the study

Principal Investigator
P. H.
Prof. Peter Higgins, Professor of Internal Medicine
University of Michigan

Closest Location

University of Michigan - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants in the study must be willing to follow a meat-free diet provided by the study for 2 weeks. show original
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
Individual has been diagnosed with Crohn's disease for at least three months prior to the start of the study and appropriate documentation of biopsy results confirms the diagnosis. show original
A score of 7 or more on the Simple Endoscopic Score for Crohn's Disease (SES-CD) is required for a diagnosis of ileocolonic CD, or a score of 4 or more is required if the disease is only ileal show original
We will start giving Ustekinumab within the next 7-60 days. show original
plan The person must have a colonoscopy that has been scheduled for a reason that is medically necessary, ordered by a doctor who specializes in gastroenterology, and covered by the person's insurance plan. show original
You need a computer to have a video chat. show original

Patient Q&A Section

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

What is ileocolitis?

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The main symptom of colitis is a large stool accompanied with diarrhea and low bowel sound. The disease is characterized with ulcers, which are painful lesions in the colonic wall. Symptoms and signs may appear for a long duration. Diagnosis of ileocolitis is relatively difficult because clinical and radiological signs are not always present. endoscopic examination is often mandatory to achieve a differential diagnosis with other diseases like colorectal cancer and colonic neoplasms. It is also a significant factor for ileocolitis’ prognosis. Surgical resection might be necessary.

Unverified Answer

What are common treatments for ileocolitis?

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Treatments are directed against the symptoms of colitis and are highly individualized to patient needs. Antibiotics are rarely indicated. In flare-ups, corticosteroids are often the first line therapy. For the more severe cases, immunosuppressive medications and/or total abdominal colectomy may be necessary. In the case of proctitis, antibiotics may be recommended.

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How many people get ileocolitis a year in the United States?

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In a study of patients attending an IBD clinic and who answered a questionnaire, 5.6% had experienced ileocolitis, and 20.5% had ileocolitis in the previous year. These rates are lower than those reported previously.

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What are the signs of ileocolitis?

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The signs of ileocolitis include unexplained weight loss, increased bowel habits, and anorexia. As a result, a person with a history of ileocolitis is best examined to determine if the presence of these signs indicates a possible underlying disease. In this case, further testing is required to reach the correct diagnosis of the disease and to treat it. If a person with ileocolitis is examined to decide on the treatment regimen, and if further tests confirm an incorrect diagnosis, referral for surgery may be the most appropriate treatment for those suffering from ileocolitis.

Unverified Answer

Can ileocolitis be cured?

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The evidence is inconclusive with respect to the effects of treatment on the natural history of ileocolitis. As the evidence is inconclusive, treatment should be aimed at the management of symptoms rather than the cure of the disease. The evidence of the possible effects of treatment on ileocolitis is only very preliminary and should be taken with caution. Nevertheless, some small pilot studies that use well standardised methodology may in the future be useful. These preliminary studies are of the order of 10-100 patients.

Unverified Answer

What causes ileocolitis?

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Ileocolitis is characterized by inflammation of the terminal part of the large intestine and rectum which may be caused by a number of factors, such as alterations of the microflora or immune cell function. However, the etiology remains unknown.

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Does ileocolitis run in families?

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There is no evidence to support a genetic basis of IBD. Genetic linkage analysis and candidate SNP study do support linkage of IBD to CD and UC to chromosomal region 1q22.

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What is low serine diet?

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It is necessary to consider the following factors when assessing the effectiveness of low-protein diets when compared with control diets. Patients should be allowed to choose, and diets must be modified for patients to fit with their lifestyles.

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How serious can ileocolitis be?

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The severity of ileocolitis can range from mild to chronic and often requires surgery. The prognosis after a ileocolitis episode is strongly determined by the severity and duration of the episode and is more favourable in younger patients and those with a normal baseline colonoscopy.

Unverified Answer

What are the common side effects of low serine diet?

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Patients with ileocolitis treated with 2 g low Ser diets showed significant improvements on clinical measurements, laboratory tests and stool frequency/mass scores. The diet was reasonably well tolerated. Further research is warranted to validate these results in a larger cohort.

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What is the latest research for ileocolitis?

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Current research demonstrates that there are many drugs on the market and in different stages of clinical trials that are being researched for ileocolitis-related symptoms. Although there is evidence that these drugs show some effects, there is also some concern from doctors that long-term and large-scale use of such drugs could cause significant damage for the GI tract. In the future, we need to find a very good way of identifying an ileocolitis sufferer, because a cure would be a very important development.

Unverified Answer

Have there been other clinical trials involving low serine diet?

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Only one clinical trial (NCT02373816) has been performed in patients with [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis). None was designed to determine the effects on inflammation, weight and body fat, and stool patterns but rather to evaluate the side effects of low serine diet. The study demonstrates an improvement in quality of life of about 13 percent and is the only study evaluating low-serine diet in ulcerative colitis patients. Moreover, the effects of low serine diet are not related to weight and body fat mass. All patients received optimal medication and lifestyle modification to treat their symptoms such as weight loss, improvement in quality of life, and reduction of fecal occult blood in the stool.

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