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Anti-inflammatory Diet for Ulcerative Colitis

N/A

Waitlist Available

Research Sponsored by Transparency Life Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females between the ages of 18 and 80, inclusive, who reside in the state of Massachusetts.

Disease duration of ≥12 weeks at the time of screening (diagnosed according to American College of Gastroenterology practice guidelines)

Must not have

Short bowel syndrome

Prior extensive colonic resection, subtotal or total colectomy or planned surgery for UC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 0, 5 and 7

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the differences between on-site and remote patient study participation in Massachusetts, as well as the impact of dietary interventions on UC.

Who is the study for?

This trial is for Massachusetts residents aged 18-80 with moderate to severe active Ulcerative Colitis (UC) confirmed by specific tests. Participants must be able to consent and follow the study procedures, including in-person or video visits depending on the group they're assigned to. Pregnant women, those with a history of substance abuse, certain UC surgeries or complications, other significant health issues, or currently in another clinical trial cannot join.

What is being tested?

The study is testing a Combined Anti-inflammatory Diet (CAID) for UC patients. It compares remote patient participation using telemonitoring and video visits against traditional on-site participation within Massachusetts. The goal is to see how diet affects UC when managed remotely versus on-site.

What are the potential side effects?

Since this trial involves dietary interventions rather than medication, side effects may include changes in digestion such as discomfort or altered bowel habits as the body adjusts to the new diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old and live in Massachusetts.

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My condition has lasted for 12 weeks or more.

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I have a history of moderate to severe active ulcerative colitis.

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I have a diagnosis of active ulcerative colitis that affects at least 25 cm from the anal verge.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have short bowel syndrome.

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I have had, or will have, major surgery for ulcerative colitis.

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I have or had an ileostomy or colostomy.

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I do not have severe health issues like heart failure or kidney problems.

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I have had or currently have a fistula or an abscess in my abdomen.

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I have been diagnosed with a severe form of colitis.

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I have Crohn's Disease.

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I have had or currently have abnormal growths in my colon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 0, 5 and 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 0, 5 and 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 5 and 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Combined Anti-inflammatory Diet (Change from baseline in fecal calprotectin/microbiome levels)

Compliance (proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study)

Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)

Secondary study objectives

Adverse Events

Dietary Compliance Comparison

Mayo Score Discrepancy Frequency

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: TraditionalActive Control1 Intervention

Subjects in Study Arm 1 will undergo a screening process, and if randomized, will follow a traditional, site-based clinical trial model and undergo a baseline visit and 3 more in-person visits with the Principal Investigator (total of 4 visits). Subjects in each Study Arm will be randomized (2:1) to follow one of two dietary regimens during the study: the Combined Anti-Inflammatory Diet (CAID) or Control (standard nutritional advice).

Group II: RemoteActive Control1 Intervention

Subjects in Study Arm 2 will undergo a screening process, and if randomized, will undergo one Baseline visit at the local Gastroenterologist's office and 4 video visits with the Principal Investigator. A mobile nurse will visit subjects at a distant location (such as their home) to obtain blood samples at visits 1 and 4. Subjects in each Study Arm will be randomized (2:1) to follow one of two dietary regimens during the study: the Combined Anti-Inflammatory Diet (CAID) or Control (standard nutritional advice).

0 / 12Eligibility criteria met