ENROLLING_BY_INVITATION

Impact of Dietary Intervention on Inflammation and Microbiome Composition Post-Colonoscopy

Conditions

Colorectal Polyp Inflammation Dietary Intervention Microbiota Colorectal Neoplasms Metabolomics Microbiome Polyps Colonoscopy Gut Health Nutrition Human Microbiome Fecal Metabolomics Serum Metabolomics Metabolomics Analysis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 investigators hypothesize that certain diets can positively influence gut bacteria, reducing inflammation and enhancing metabolic signals. To explore this, they will utilize metagenomic testing on stool samples to analyze the DNA of gut microorganisms. Additionally, they will conduct immune profiling on serum samples and perform metabolomic analysis to comprehensively evaluate the diet-induced changes in immune response and metabolic pathways. This multi-faceted approach will help them understand how dietary changes affect the composition and function of the gut microbiome, immune function, and overall metabolism.

Official Title

Determining the Impact of Dietary Intervention on Inflammation and Microbiome Composition in Patients With Recurrent Polyps Post-Colonoscopy.

Quick Facts

Study Start:2025-03-04

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ENROLLING_BY_INVITATION

Study ID

NCT06603519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. Inability to provide informed consent and engage in informed consent procedures. 2. Participants who suffer from allergic reactions to, or are unwilling to consume, any components of the dietary intervention. 3. Pregnant 4. Serious illness and in hospice or palliative care for terminal disease 5. Swallowing issues, including self-reported difficulty tolerating solids or liquids. 6. Active antibiotics use for an ongoing acute infection. 7. 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. 8. Participants who plan to relocate to an area not served by UCSD or travel plans that do not permit completion of the study. 9. Possible ethanol (alcohol) use disorder defined by Alcohol Use Disorders Identification Test (AUDIT) score of \>15 10. Hyper-tension \>160/100mmHg 11. Exacerbation of underlying gastrointestinal disease, including chronic inflammatory bowel disease or other malabsorptive disorders 12. Decompensated cirrhosis 13. Previously diagnosed Diabetes Mellitus with HbA1c \>9% at screening 14. Newly diagnosed diabetes within the past three months, or HbA1c \>6.5% at screening in a person not previously diagnosed with diabetes. 15. Participants with a history of end-stage renal disease (ESRD) on hemodialysis 16. Active infectious diseases (e.g., active tuberculosis \< 3 months from symptom onset or positive test, COVID \< 1 month from symptom onset or positive test) 17. Participants who require dietary restrictions due to a medical condition or are on a prescribed diet for underlying chronic diseases. 18. Participants with Type 1 or Type 2 diabetes on insulin 19. 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 20. Hospitalization for a chronic disease (e.g., congestive heart failure, stroke) within the past three months 21. Requiring transfusions/apheresis during study period 22. Participants with a current diagnosis of, or who have received treatment for, bulimia or anorexia nervosa within the past 3 years 23. 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. 24. Hemoglobin \<9.5 g/dL at screening 25. Myocardial infarction, invasive cardiac procedure, participation in a cardiac or acute rehabilitation programs, transient ischemic attacks, or unstable arrhythmias within the past 3 months.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. Inability to provide informed consent and engage in informed consent procedures.
2. Participants who suffer from allergic reactions to, or are unwilling to consume, any components of the dietary intervention.
3. Pregnant
4. Serious illness and in hospice or palliative care for terminal disease
5. Swallowing issues, including self-reported difficulty tolerating solids or liquids.
6. Active antibiotics use for an ongoing acute infection.
7. 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.
8. Participants who plan to relocate to an area not served by UCSD or travel plans that do not permit completion of the study.
9. Possible ethanol (alcohol) use disorder defined by Alcohol Use Disorders Identification Test (AUDIT) score of \>15
10. Hyper-tension \>160/100mmHg
11. Exacerbation of underlying gastrointestinal disease, including chronic inflammatory bowel disease or other malabsorptive disorders
12. Decompensated cirrhosis
13. Previously diagnosed Diabetes Mellitus with HbA1c \>9% at screening
14. Newly diagnosed diabetes within the past three months, or HbA1c \>6.5% at screening in a person not previously diagnosed with diabetes.
15. Participants with a history of end-stage renal disease (ESRD) on hemodialysis
16. Active infectious diseases (e.g., active tuberculosis \< 3 months from symptom onset or positive test, COVID \< 1 month from symptom onset or positive test)
17. Participants who require dietary restrictions due to a medical condition or are on a prescribed diet for underlying chronic diseases.
18. Participants with Type 1 or Type 2 diabetes on insulin
19. 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
20. Hospitalization for a chronic disease (e.g., congestive heart failure, stroke) within the past three months
21. Requiring transfusions/apheresis during study period
22. Participants with a current diagnosis of, or who have received treatment for, bulimia or anorexia nervosa within the past 3 years
23. 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.
24. Hemoglobin \<9.5 g/dL at screening
25. Myocardial infarction, invasive cardiac procedure, participation in a cardiac or acute rehabilitation programs, transient ischemic attacks, or unstable arrhythmias within the past 3 months.

Contacts and Locations

Study Locations (Sites)

University of California, San Diego Altman Clinical and Translational Research Institute

San Diego, California, 92037

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-04

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-03-04

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Dietary Intervention
Inflammation
Microbiome
Polyps
Colonoscopy
Gut Health
Nutrition
Human Microbiome
Fecal Metabolomics
Serum Metabolomics
Metabolomics Analysis

Additional Relevant MeSH Terms

Colorectal Polyp
Inflammation
Dietary Intervention
Microbiota
Colorectal Neoplasms
Metabolomics