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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 5 and 7
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Adverse Events
Dietary Compliance Comparison
Mayo Score Discrepancy Frequency
+3 moreTrial 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).
Find a Location
Who is running the clinical trial?
Transparency Life SciencesLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Tomasz Sablinski, MD, PhDStudy DirectorTransparency Life Sciences
2 Previous Clinical Trials
281 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have short bowel syndrome.I am between 18 and 80 years old and live in Massachusetts.I have had, or will have, major surgery for ulcerative colitis.You have a recent history of alcohol, drug, or chemical abuse.I have or had an ileostomy or colostomy.I do not have severe health issues like heart failure or kidney problems.My condition has lasted for 12 weeks or more.I have had or currently have a fistula or an abscess in my abdomen.I am using anticoagulants, herbal supplements, or omega-3/fish oil.I have been diagnosed with a severe form of colitis.I have Crohn's Disease.I have a history of moderate to severe active ulcerative colitis.I stopped using tube feeding or IV nutrition more than 3 weeks ago.I have a diagnosis of active ulcerative colitis that affects at least 25 cm from the anal verge.I have had or currently have abnormal growths in my colon.You are already participating in another clinical trial.
Research Study Groups:
This trial has the following groups:- Group 1: Traditional
- Group 2: Remote
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What qualifications must a person possess to participate in this medical trial?
"To participate in this trial, applicants must meet the criteria of having colitis ulcerative and be within the age range of 18 to 80. A total of 51 individuals are sought after for enrolment."
Answered by AI
Does this research study permit persons over the age of fifty to participate?
"In order to be eligible for this trial, applicants must not exceed 80 years of age and must have attained the legal age of consent."
Answered by AI
Are there opportunities for people to volunteer in this investigation?
"Clinicaltrials.gov records indicate that this trial, initially posted on January 1st 2015 and last updated November 5th of the same year, is not currently recruiting patients for participation. However, there are an additional 399 studies actively looking to enrol individuals at present."
Answered by AI
What outcomes are researchers hoping to attain through this research endeavor?
"Transparency Life Sciences, the study sponsor, has identified Endoscopy Mayo Score Comparison as the primary outcome that will be measured after Week 7. This trial is also assessing Adverse Events (AEs) and Serious Adverse Events (SAEs), Mayo Score Discrepancy Frequency, and Physician's Global Assessment Discrepancy Frequency for secondary outcomes."
Answered by AI
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