Effect of Preoperative Diet on Perioperative Gut Microbiome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2025-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to evaluate the gut microbiome (i.e. bacteria, viruses, and fungi that reside in the gut) of people undergoing abdominal surgery, evaluate whether specific diets can change the gut microbiome, and, if so, whether those changes translate into better surgical outcomes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery

NCT06349590

Colorectal Cancer

RECRUITING PHASE1/PHASE2

Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients

NCT06513416

Gut Microbiota Postoperative Pulmonary Complications

RECRUITING

Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery

NCT00662376

Enteral Nutrition Regimen Prior to Surgery

COMPLETED NA

The Effect of Gut Microbiota on Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma

NCT04303286

Gut Microbiota Hepatocellular Carcinoma

COMPLETED

Effects of Nutritional Preconditioning on the Patient's Outcomes After Surgery

NCT03692507

Major Abdominal/GI Surgery

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Standard of care: patients undergoing major abdominal colorectal surgery are sometimes advised to eat healthfully prior to surgery, but without more specific recommendations regarding their diet.

Research Activities:

1. Screening: eligible patients will be identified through screening the clinic schedules.
2. Enrollment: in person or remotely, after the patient is determined to require major abdominal surgery, they will be invited to participate in the study. If they consent to participate, they will be randomized to receive either low-fat/high-fiber diet, high-fermented diet, or continue with their normal diet for 10-14 days prior to the surgery.
3. Intervention: at baseline, data will be collected regarding clinical information of the patients (age, body mass index, comorbidities, medications or supplements, physical activity levels, antibiotic or probiotic use in the past six months), and baseline dietary pattern, which will be evaluated through application of a validated Food Frequency Questionnaire (DHQ III). Patients in the intervention arms (low- fat/high-fiber diet or high-fermented diet) will receive meal samples during the 10-14 days preceding surgery. Patients in the control arm will receive a $25 grocery voucher. Adherence to the diet will be assessed through regular check ins with the patients.

Stool samples will be collected in five timepoints: at the beginning of the study, after the dietary intervention, during surgery, in the first week after the surgery, and between 21-30 days after surgery. The stool samples will be sent for analysis of the microbiome.

A fragment of the resected bowel will also be sent for analysis of the mucosal-associated microbiome.
4. Closeout: After surgery, all patients will receive the same standard dietary protocol and care, and will be followed for 30 days without any further intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Site Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Arm

Standard care - patients will not receive specific dietary advice.

Group Type NO_INTERVENTION

No interventions assigned to this group

High Fiber/low fat

Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.

Group Type EXPERIMENTAL

high-fiber/low fat

Intervention Type BEHAVIORAL

high fiber/low fat preoperative diet

Fermented

Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.

Group Type EXPERIMENTAL

fermented

Intervention Type BEHAVIORAL

fermented preoperative diet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

high-fiber/low fat

high fiber/low fat preoperative diet

Intervention Type BEHAVIORAL

fermented

fermented preoperative diet

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* undergoing major abdominal colorectal surgery with intestinal resection in 2 or more weeks

Exclusion Criteria

* patients who do not speak English or Spanish
* houseless patients
* decisionally impaired patients
* presence of ileostomy prior to the surgical procedure
* surgery without intestinal resection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No