Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 79 Years|
- - I.
- II. Is over the age of 18 years.
- III. Has a diagnosis of ulcerative colitis for over a 3-month duration that was confirmed by a specialist gastroenterologist with a MAYO score up to 9.
- IV. Medications: 1.
- V. Willing to participate in the study and comply with the proceedings by signing a written informed consent.
- VI. Free of any clinically significant disease, other than ulcerative colitis, that would interfere with the study's evaluations.
- VII. Subjects can read and understand English and is able to adhere to the study methodology and visit schedules.
- - I.
- II. Has been on antibiotics within the last four weeks.
- III. Has a known food allergy to nuts, soy, eggs or dairy.
- IV. Is pregnant or breast feeding.
- V. Following a vegetarian, vegan or low FODMAP diet.
- VI. Has known dementia and the inability to understand the trial requirements.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Edith Cowan University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
This study will review whether a lacto-ovo vegetarian diet is an optimal dietary therapy to achieve a clinical response in mild to moderate UC as an adjunctive treatment to current medical therapies. The proposed RCT will be used to evaluate the efficacy of a lacto-ovo vegetarian diet together with its effect on the microbiota to create an enhanced understanding of the role diet plays in the management of UC. Using a socially acceptable diet it is anticipated that food-related quality-of-life measures will improve for participants. Dietary modification could be a more economical, safer and more effective means of reducing symptoms and flare-ups compared to pharmacological therapy.
No Intervention: Control Group
Patients will be asked to continue their usual diet patterns over an 8 week period
Experimental: Intervention Group
Patients will follow a lacto-ovo vegetarian diet for an 8 week period. patients will be provided with a lacto-ovo vegetarian food box delivery service with fresh ingredients and recipes to cover four dinners per week.
Other: - Lacto-ovo vegetarian diet
Lacto-ovo vegetarian diet inclusive of dairy and eggs
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.