NCT05592886

Brief Summary

This multicenter, double blinded randomized controlled trial aims to assess the efficacy of a novel oral synbiotic formula (SMT04) in reducing advanced adenoma recurrence and colorectal neoplasia-related bacterial gene markers after endoscopic resection of colorectal advanced neoplasia.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
649

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Dec 2022Dec 2027

First Submitted

Initial submission to the registry

October 17, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

October 17, 2022

Last Update Submit

July 29, 2025

Conditions

Colorectal NeoplasmsColorectal AdenomaColorectal CancerAdvanced Adenoma

Keywords

Adenoma recurrenceBacterial marker

Outcome Measures

Primary Outcomes (1)

  • The incidence of metachronous recurrent advanced colorectal neoplasia at year 1 (local or at other sites).

    The proportion of patients with metachronous recurrent advanced neoplasia at year 1

    1 year

Secondary Outcomes (6)

  • Incidence of recurrent colorectal adenomas at year 1

    1 year

  • Number of recurrent advanced neoplasia at year 1

    1 year

  • Number of recurrent adenomas at year 1

    1 year

  • Changes in the levels of bacterial gene markers

    1 year

  • Correlation between recurrent advanced colorectal neoplasia and the changes in levels of bacterial gene markers

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

Receive SMT04 formula

Other: SMT04 formula

Placebo arm

PLACEBO COMPARATOR

Receive active placebo

Other: Active placebo

Interventions

SMT04 formulaOTHER

The SMT04 formula is a synbiotic containing probiotics and prebiotics

Intervention arm
Active placeboOTHER

The active placebo is 2 mg Vitamin C with an inert substance made of starch filler. The flavor, coloring and appearance are unidentifiable to the study product.

Placebo arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who have advanced colorectal neoplasia\* removed and confirmed by histopathology;
  • They have received high quality colonoscopies before or during endoscopic resection (defined as a full colonoscopy with successful caecal intubation, and a Boston Bowel Preparation Scale ≧2 in each colonic segment) with no residual colorectal neoplasia;
  • Aged 18-90 years old;
  • Written informed consent obtained
  • An advanced colorectal neoplasia is defined as an advanced adenoma, sessile serrated lesion or non-invasive colorectal cancer (stage Tis or T1a). Advanced adenoma is defined as an adenoma larger than 10mm, and/or with villous component ≥20%, and/or harboring high grade dysplasia.

You may not qualify if:

  • Known residual colorectal neoplasia not removed (except hyperplastic polyps);
  • Contraindications to endoscopic resection due to deep submucosal invasion (stage T1b or above);
  • Prior surgical resection of colon;
  • Personal history of hereditary polyposis syndrome or inflammatory bowel disease;
  • Known pregnancy or lactation;
  • Immunocompromised status (e.g. on immunosuppressants (except 5-aminosalicylic acid or short term use of corticosteroids \<4 weeks), on chemotherapy, bone marrow or solid organ transplant, human immunodeficiency virus, congenital immune deficiency);
  • Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);
  • Refusal to undergo surveillance colonoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, China

NOT YET RECRUITING

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Louis Lau

    Prince of Wales Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis Lau

CONTACT

35052211louishslau@cuhk.edu.lhk

Study Design

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

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 25, 2022

Study Start

December 15, 2022

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)HK(1)