Trial Title:
Impact of Dietary Intervention on Inflammation and Microbiome Composition Post-Colonoscopy
NCT ID:
NCT06603519
Condition:
Colorectal Polyp
Inflammation
Dietary Intervention
Microbiota
Colorectal Neoplasms
Metabolomics
Conditions: Official terms:
Colorectal Neoplasms
Inflammation
Polyps
Conditions: Keywords:
Dietary Intervention
Inflammation
Microbiome
Polyps
Colonoscopy
Gut Health
Nutrition
Human Microbiome
Fecal Metabolomics
Serum Metabolomics
Metabolomics Analysis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Modified Plant-Based Mediterranean Diet
Description:
Two-week dietary intervention after the participants' scheduled colonoscopy consisting of
vegetarian high-fiber meals. These meals are designed to provide a substantial intake of
dietary fiber through a variety of plant-based foods, including whole grains, legumes,
fruits, vegetables, nuts, and seeds. Meals will be delivered bi-weekly, and compliance
will be monitored through regular check-ins with a study dietitian.
Arm group label:
Dietary Intervention Group
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 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.
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 diseases such as obesity, type 2 diabetes mellitus (T2DM),
and cardiovascular disease. Metagenomic analyses have revealed microbial biomarkers and
ecological signatures in the fecal microbiome of CRC patients, correlating with chronic
inflammation and gut dysbiosis. These factors have demonstrated prognostic relevance for
CRC akin to other precursors, including conventional adenoma and serrated polyps.
Bowel lavage, a standard practice for facilitating colonoscopies, may affect the
interaction between gut microbes and intestinal phenotypes. Standard bowel preparations
have immediate impacts on gut microbiota composition, with alterations typically lasting
around 14 days before a partial return to baseline. These changes in gut microbial
diversity likely contribute to minor colonoscopy complications such as abdominal
discomfort, bloating, diarrhea, and constipation during the recovery period.
Post-bowel lavage dietary intervention could potentially minimize lavage-associated side
effects by promoting microbial diversity restoration and systemic inflammation reduction.
In a previous mouse study, the investigators discovered that the Standard American Diet
(SAD) led to the proliferation of opportunistic pathogens following surgical lavage. This
change in microbial composition was linked to increased systemic inflammation and a
higher incidence of surgical complications. Additionally, they observed that a
high-fiber, low-saturated-fat diet-like a whole food, plant-based (WFPB), Med/DASH diet,
and modified Mediterranean diet-can reverse this inflammatory phenotype.
However, there is a lack of interventional trials investigating the health benefits of
specific dietary interventions following bowel lavage. Therefore, the investigators
propose a human intervention study to assess if daily consumption of a high-fiber diet
after colonoscopy will alter the intestinal microbiota, decrease inflammation, and
improve digestive health.
This will be a controlled intervention study involving 30 subjects who will be enrolled
on a rolling basis as they are identified during the recruitment period. The study begins
with an initial visit at Week 1, where blood is collected for immune profiling and
metabolomics, and participants start weekly stool collection using the S-Wipe method. At
Week 2, a GutLab device is installed in participants' homes for daily stool collection.
The colonoscopy occurs at Week 4, followed by a 2-week high-fiber diet provided by
Thistle. Throughout the study, blood draws (6 mL) are performed at Weeks 1, 4, 6, and 8,
while stool samples are collected weekly via S-Wipe and daily via GutLab. Participants
log their food intake with a dietitian three times per week during Weeks 3, 5, and 7, and
body composition measurements are taken before the colonoscopy and at the final visit.
The study aims to quantify how dietary intervention affects post-lavage microbiome,
metabolome, and immune response through analysis of blood and stool samples. Optional
follow-ups at 1, 3, and 5 years will assess polyp recurrence. This design enables a
comprehensive assessment of a high-fiber diet's impact on intestinal microbiota,
inflammation, and digestive health in individuals with a history of polyps undergoing
colonoscopy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Due for 2nd or 3rd colonoscopy with prior diagnosis of tubular, villous, or serrated
polyps but no current diagnosis of CRC.
Exclusion Criteria:
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
Uncontrolled disease states:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
September 30, 2024
Completion date:
February 2026
Lead sponsor:
Agency:
University of California, San Diego
Agency class:
Other
Collaborator:
Agency:
Seerave Foundation
Agency class:
Other
Source:
University of California, San Diego
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06603519
