Status:
RECRUITING
Impact of Dietary Intervention on Inflammation and Microbiome Composition Post-Colonoscopy
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Seerave Foundation
Conditions:
Colorectal Polyp
Inflammation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to investigate the impact of various healthy diets, specifically a modified plant-based Mediterranean diet, on the gut microbiome and overall well-being post-colonoscopy. The investiga...
Detailed Description
An altered intestinal gut microbiota, i.e. dysbiosis, has been associated with the development of intestinal diseases including inflammatory bowel disease, colorectal cancer (CRC), and metabolic disea...
Eligibility Criteria
Inclusion
- 1\. Due for 2nd or 3rd colonoscopy with prior diagnosis of tubular, villous, or serrated polyps but no current diagnosis of CRC.
Exclusion
- Inability to provide informed consent and engage in informed consent procedures.
- Participants who suffer from allergic reactions to, or are unwilling to consume, any components of the dietary intervention.
- Pregnant
- Serious illness and in hospice or palliative care for terminal disease
- Swallowing issues, including self-reported difficulty tolerating solids or liquids.
- Active antibiotics use for an ongoing acute infection.
- Any disorder, unwillingness, or inability not covered by any other exclusion criteria which, in the investigator's and/or team's opinion jeopardizes the safety of the participant or others or would interfere with adherence to the protocol.
- Participants who plan to relocate to an area not served by UCSD or travel plans that do not permit completion of the study.
- Possible ethanol (alcohol) use disorder defined by Alcohol Use Disorders Identification Test (AUDIT) score of \>15
- Uncontrolled disease states:
- Hyper-tension \>160/100mmHg
- Exacerbation of underlying gastrointestinal disease, including chronic inflammatory bowel disease or other malabsorptive disorders
- Decompensated cirrhosis
- Previously diagnosed Diabetes Mellitus with HbA1c \>9% at screening
- Newly diagnosed diabetes within the past three months, or HbA1c \>6.5% at screening in a person not previously diagnosed with diabetes.
- Participants with a history of end-stage renal disease (ESRD) on hemodialysis
- Active infectious diseases (e.g., active tuberculosis \< 3 months from symptom onset or positive test, COVID \< 1 month from symptom onset or positive test)
- Participants who require dietary restrictions due to a medical condition or are on a prescribed diet for underlying chronic diseases.
- Participants with Type 1 or Type 2 diabetes on insulin
- Participants aged 2: 75 years with Type 2 diabetes taking prescribed medications that can cause hypoglycemia (e.g., sulfonylureas, glinides), or on a prescribed diet
- Hospitalization for a chronic disease (e.g., congestive heart failure, stroke) within the past three months
- Requiring transfusions/apheresis during study period
- Participants with a current diagnosis of, or who have received treatment for, bulimia or anorexia nervosa within the past 3 years
- Participants with major psychiatric disorders, including major depression, schizophrenia, or psychosis, who have been hospitalized in the past six (6) months or are currently enrolled in treatment programs.
- Hemoglobin \<9.5 g/dL at screening
- Myocardial infarction, invasive cardiac procedure, participation in a cardiac or acute rehabilitation programs, transient ischemic attacks, or unstable arrhythmias within the past 3 months.
Key Trial Info
Start Date :
March 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06603519
Start Date
March 4 2025
End Date
February 1 2026
Last Update
March 7 2025
Active Locations (1)
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1
University of California, San Diego Altman Clinical and Translational Research Institute
San Diego, California, United States, 92037