Diet Intervention for Ulcerative Colitis

Overseen By Joanne Stempak

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mount Sinai Hospital, Canada

Must not be taking: NSAIDs, Antibiotics

Disqualifiers: Pregnancy, PSC, Colorectal neoplasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special diet to determine if it can help people with ulcerative colitis by improving gut health and reducing symptoms. The focus is on using food to positively change the gut bacteria balance. People with mild to moderate ulcerative colitis, who have experienced symptoms like stomach pain or diarrhea, may be suitable candidates. Participants will first maintain their usual diet, then switch to the UC intervention diet for eight weeks to assess its effectiveness. As an unphased trial, this study offers a unique opportunity to explore dietary changes that could improve the condition.

Will I have to stop taking my current medications?

The trial requires that you do not change your current medications within 4 weeks before starting the study and during the study itself.

What prior data suggests that this diet is safe for individuals with ulcerative colitis?

Research has shown that certain diets are safe for people with ulcerative colitis (UC). For example, a short-term low FODMAP diet has proven safe and may reduce inflammation and improve quality of life for UC patients. This suggests that dietary changes can safely manage symptoms.

Although specific data on the safety of the diet used in this trial is not available, diet plays a crucial role in managing UC. Some foods can worsen symptoms, while others may improve them. Generally, dietary changes are considered safe, especially when monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for ulcerative colitis, which often include medications like aminosalicylates, corticosteroids, and immunosuppressants, the UC intervention diet offers a fresh approach by focusing on dietary changes. Researchers are excited about this treatment because it aims to manage symptoms through nutrition, potentially reducing the need for medication and its associated side effects. The intervention diet is specially designed to provide targeted nutrients that may help modulate inflammation and improve gut health. This innovative approach could offer patients a more natural and sustainable way to manage their condition.

What evidence suggests that this diet is effective for ulcerative colitis?

Research shows that changing diet can help manage symptoms of ulcerative colitis (UC). One study found that a new diet improved the balance of good and bad bacteria in the gut of people with UC. This trial will test a specially designed UC intervention diet to see if it can reduce disease activity. However, other studies found that some specific diets, such as those eliminating certain proteins, did not maintain remission. Overall, dietary changes might help, but results can vary depending on the specific diet used. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with a history of over 10cm of ulcerative colitis (UC) involvement, an established diagnosis, and active UC as indicated by certain test scores. Smokers must not change habits during the study. Participants should be on stable medical therapy without changes for 4 weeks before and during the study.

Inclusion Criteria

Your disease has affected an area larger than 10 centimeters at some point in the past.

Must have established diagnosis of UC by standard endoscopic, radiographic, or histological criteria

Must have active UC defined by having a Mayo score equal to or greater than 2 within two months prior to enrollment

Exclusion Criteria

You have allergies or sensitivities to many of the foods in the study diet.

Confirmed C. difficile infection within 3 months of recruitment

Pregnant or lactating females

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Observation

Participants are observed for 14 days on their traditional diet to establish baseline measurements

2 weeks

Treatment

Participants follow an 8-week intervention with a specially designed diet to alter the microbiome

8 weeks

Follow-up

Participants are monitored for changes in microbiome composition and disease activity

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• UC intervention diet

Trial Overview The trial is testing a non-elemental diet designed to act as a probiotic to modify the microbiome in UC patients, aiming to reduce disease activity. It's assessing if this dietary intervention can be a sustainable treatment option.

How Is the Trial Designed?

Group I: Ulcerative colitis patients with mild to moderate activity Experimental Treatment 1 Intervention

Participants will be followed for 14 days on their traditional diet followed by an 8 week intervention with the specially designed and provided treatment diet.

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10574654/

Dietary Interventions in Ulcerative Colitis: A Systematic ... Carrageenan-free, anti-inflammatory, and cow milk protein elimination diets showed no significant advantages in maintaining clinical remission.

2. nature.com nature.com/articles/s41598-024-64512-8

Effectiveness of a novel diet in attenuation of clinical ... Previous studies showed that it can be useful for managing the symptoms of UC patients and improves the ratio between pathogenic microorganisms ...

3. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/s12937-025-01075-y

Dietary content and eating behavior in ulcerative colitis This review provides insights into the impact of dietary content and eating behaviors on UC, focusing on specific food, food groups, nutrients, and ...

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1586691/full

Association between pro-inflammatory diet and ulcerative ... The meta-analysis indicated that an inflammatory or pro-inflammatory diet did not increase the risk of UC (OR = 0.97, 95% CI = 0.84–1.12).

5. gastrojournal.org gastrojournal.org/article/S0016-5085(19)30129-5/fulltext

P016 META-ANALYSIS OF DIETARY INTERVENTION ... This meta-analysis seeks to assess the collective effectiveness of dietary interventions on health outcomes related to Crohn's Disease and Ulcerative Colitis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10284595/

A Systematic Review of the Role of Diet in Ulcerative Colitis Diet is an important part of UC management because it can either aggravate or alleviate symptoms along with medication therapy.

7. sciencedirect.com sciencedirect.com/science/article/pii/S016041202500457X

Excessive ultra-processed foods exposure aggravates ... Clinically, dietary analysis revealed a positive correlation between KS intake and Mayo score in UC patients (p < 0.01). Furthermore, in a C57BL/6 mouse model, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02345733

Study Details | NCT02345733 | Use of a Novel Diet (UC ... The goal of the study is to evaluate strategies that target the microbiota for the treatment of Ulcerative Colitis , This study will involve a novel diet that ...