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NCT06603519Enrolling by invitation

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

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

Source: ClinicalTrials.gov · Last updated 5 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
30 (estimated)
First submitted
12 Sept 2024
Start date
4 Mar 2025
Primary completion date
Nov 2026
Lead sponsor
University of California, San Diego
NCT number
NCT06603519

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 4 Mar 2025 to the primary completion date, Nov 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants with a current diagnosis of, or who have received treatment for, bulimia or anorexia nervosa within the past 3 years

Other illness

  • Participants who suffer from allergic reactions to, or are unwilling to consume, any components of the dietary intervention.
  • Serious illness and in hospice or palliative care for terminal disease
  • 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.
  • Possible ethanol (alcohol) use disorder defined by Alcohol Use Disorders Identification Test (AUDIT) score of \>15
    • Uncontrolled disease states:
  • Exacerbation of underlying gastrointestinal disease, including chronic inflammatory bowel disease or other malabsorptive disorders
  • 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
  • Hospitalization for a chronic disease (e.g., congestive heart failure, stroke) within the past three months
  • 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.
  • Myocardial infarction, invasive cardiac procedure, participation in a cardiac or acute rehabilitation programs, transient ischemic attacks, or unstable arrhythmias within the past 3 months.

Lab values

  • 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.
  • Hemoglobin \<9.5 g/dL at screening

Age

  • 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

Other

  • Inability to provide informed consent and engage in informed consent procedures.
  • Pregnant
  • Swallowing issues, including self-reported difficulty tolerating solids or liquids.
  • Participants who plan to relocate to an area not served by UCSD or travel plans that do not permit completion of the study.
  • Hyper-tension \>160/100mmHg
  • Decompensated cirrhosis
  • Requiring transfusions/apheresis during study period

Who the study is looking for

  • 1\. Due for 2nd or 3rd colonoscopy with prior diagnosis of tubular, villous, or serrated polyps but no current diagnosis of CRC.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of California, San Diego Altman Clinical and Translational Research Institute
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.