NCT05027763

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2024

Enrollment Period

3.3 years

First QC Date

August 17, 2021

Last Update Submit

March 19, 2025

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • Change in gut microbiome alpha and beta diversity according to pre-operative diet intervention

    Metagenomic sequencing will be performed on stool samples before and after dietary change.

    Two weeks prior to surgery

Secondary Outcomes (2)

  • Change in gut microbiome alpha and beta diversity after surgery according to pre-operative diet

    Surgery date until 1 month after surgery

  • Frequency and severity of surgical complications according to pre-operative diet

    30 days after surgery

Study Arms (3)

Control Arm

NO INTERVENTION

Standard care - patients will not receive specific dietary advice.

High Fiber/low fat

EXPERIMENTAL

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

Behavioral: high-fiber/low fat

Fermented

EXPERIMENTAL

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

Behavioral: fermented

Interventions

high-fiber/low fatBEHAVIORAL

high fiber/low fat preoperative diet

High Fiber/low fat
fermentedBEHAVIORAL

fermented preoperative diet

Fermented

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

Related Publications (4)

  • Hyoju SK, Adriaansens C, Wienholts K, Sharma A, Keskey R, Arnold W, van Dalen D, Gottel N, Hyman N, Zaborin A, Gilbert J, van Goor H, Zaborina O, Alverdy JC. Low-fat/high-fibre diet prehabilitation improves anastomotic healing via the microbiome: an experimental model. Br J Surg. 2020 May;107(6):743-755. doi: 10.1002/bjs.11388. Epub 2019 Dec 26.

    PMID: 31879948BACKGROUND

  • Kok DE, Arron MNN, Huibregtse T, Kruyt FM, Bac DJ, van Halteren HK, Kouwenhoven EA, Wesselink E, Winkels RM, van Zutphen M, van Duijnhoven FJB, de Wilt JHW, Kampman E. Association of Habitual Preoperative Dietary Fiber Intake With Complications After Colorectal Cancer Surgery. JAMA Surg. 2021 Jun 16;156(9):1-10. doi: 10.1001/jamasurg.2021.2311. Online ahead of print.

    PMID: 34132738BACKGROUND

  • Wastyk HC, Fragiadakis GK, Perelman D, Dahan D, Merrill BD, Yu FB, Topf M, Gonzalez CG, Van Treuren W, Han S, Robinson JL, Elias JE, Sonnenburg ED, Gardner CD, Sonnenburg JL. Gut-microbiota-targeted diets modulate human immune status. Cell. 2021 Aug 5;184(16):4137-4153.e14. doi: 10.1016/j.cell.2021.06.019. Epub 2021 Jul 12.

    PMID: 34256014BACKGROUND

  • Slankamenac K, Nederlof N, Pessaux P, de Jonge J, Wijnhoven BP, Breitenstein S, Oberkofler CE, Graf R, Puhan MA, Clavien PA. The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg. 2014 Nov;260(5):757-62; discussion 762-3. doi: 10.1097/SLA.0000000000000948.

    PMID: 25379846BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 30, 2021

Study Start

March 1, 2022

Primary Completion

June 1, 2025

Study Completion

September 20, 2025

Last Updated

March 24, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)