MedDataX Logo

Gut Microbiome and Colorectal Cancer

NCT ID: NCT06748339

Last Updated: 2024-12-27

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

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-17

Brief Summary

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

Colorectal cancer (CRC) is reported to be the third leading cause of cancer deaths worldwide, and its prevalence is steadily rising in developing countries. It can be considered a marker of socioeconomic development and a marker of significant changes in food habits and lifestyle. In Egypt, CRC represents the seventh most common cancer. It is the third most reported cancer in males and the fifth most common cancer in females. microbiome dysbiosis may be involved in the pathogensis and thus pose a therapeutic target

Detailed Description

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

Many reports suggested the role of westernized dietary lifestyles, including high consumption of red meats, animal fats, and cholesterol-rich foods, as well as smoking, decreased physical activity, obesity, diabetes, alcohol consumption, or smoking, in CRC development. These changes in lifestyle are called the external factors, which are now linked to changes in the inner gut microenvironments, mainly the microbiomes. Our aim is to investigate the the changes in microbiome profile in relation to clinical, pathological and lifestyle factors

Conditions

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

Colorectal Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

CRC microbiome

Study Design

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

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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

contol group

6 healthy participants

no intervention

Intervention Type OTHER

no intervention

CRC group

12 newly diagnosed CRC patients

no intervention

Intervention Type OTHER

no intervention

Interventions

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

no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Age of 40 years to 80 years
* Patients with a newly diagnosed CRC

Exclusion Criteria

* Patients with previously known CRC
* Pregnancy or Lactation
* Abdominal surgery within/up to 6 months prior to sample collection
* Antibiotics, corticosteroids, or probiotics up to three months prior to sample collection
* History of other types of cancer
* Subjects on a special diet
* Diabetes, liver, or kidney diseases
* CRC patients who used enema or underwent colonoscopy up to one week before sample collection.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heliopolis University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sara mostafa ElAdawy

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

sara M eladwy

Role: PRINCIPAL_INVESTIGATOR

Heliopolis University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

cairo university Hopitals (elKasr ELieny )

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

Baas FS, Brusselaers N, Nagtegaal ID, Engstrand L, Boleij A. Navigating beyond associations: Opportunities to establish causal relationships between the gut microbiome and colorectal carcinogenesis. Cell Host Microbe. 2024 Aug 14;32(8):1235-1247. doi: 10.1016/j.chom.2024.07.008.

Reference Type BACKGROUND
PMID: 39146796 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://pubmed.ncbi.nlm.nih.gov/39146796/

Navigating beyond associations: Opportunities to establish causal relationships between the gut microbiome and colorectal carcinogenesis

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HU.REC.H10-2024

Identifier Type: -

Identifier Source: org_study_id