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A Prospective Longitudinal Cohort Study on Brain-Gut Axis Characteristic Indicators in Patients with Ileostomy for Preventive Purposes

A Prospective Longitudinal Cohort Study on Brain-Gut Axis Characteristic Indicators in Patients with Ileostomy for Preventive Purposes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101128
Enrollment
Unknown
Registered
2025-04-21
Start date
2025-04-25
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Rectal and Colorectal Cancer

Interventions

Non-stoma group:no
Stoma group:no

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Study participants aged 18-80 years; 2. Patients newly diagnosed with low rectal or colorectal cancer, scheduled to undergo stage I radical colorectal cancer surgery (Dixon procedure) along with prophylactic ileostomy, followed by ileostomy closure after six months, or stage I radical colorectal cancer surgery (Dixon procedure) alone; 3. Patients who have not received chemotherapy, radiotherapy, or immunotherapy prior to their colorectal cancer diagnosis; 4. Patients without significant dietary preferences (e.g., strong preferences for specific foods such as a pronounced liking for sweets or spicy foods); 5. No history of other gastrointestinal diseases (excluding intestinal polyps and gallstones); 6. Willing to participate in the study and sign informed consent; 7. For patients in the stoma group, the intraoperative confirmed length of the bypassed ileal segment is 15-20 cm.

Exclusion criteria

Exclusion criteria: 1. The patient was found to have multiple tumors during preoperative examinations; 2. The patient has concurrent infectious diseases or autoimmune diseases; 3. The patient has congenital or acquired metabolic disorders; 4. The patient took antibiotics or probiotics within two weeks prior to enrollment in the study; 5. The surgical plan was altered, and ileostomy was not performed during the first-stage surgery; 6. For certain reasons, the patient did not undergo stoma reversal; 7. Tumor progression occurred in the patient prior to the reversal surgery; 8. Life expectancy is less than one year; 9. End-stage tumor; 10. Complications such as cerebrovascular disease, neurodegenerative diseases, epilepsy, psychiatric disorders, brain tumors, anorexia, pica, uncontrolled obesity, or other conditions affecting food intake; 11. Special dietary practices such as vegetarianism or halal diets; 12. Presence of metallic implants in the body or claustrophobia, making the patient unsuitable for brain MRI; 13. A confirmed preoperative diagnosis of anxiety or depression.

Design outcomes

Primary

MeasureTime frame
Pallidal volume at T2 time point between the two groups;

Secondary

MeasureTime frame
Volumes of the globus pallidus and hypothalamus across different time points for each group;Psychological and behavioral questionnaires for each group at different time points;Gut and Serum Metabolomic Changes;Changes in Serum Hormone Levels;Colony changes in microbiome metagenomic analysis.;Characteristics of the globus pallidus and hypothalamic regions in 7T magnetic resonance spectroscopic imaging across different time points;

Countries

China

Contacts

Public ContactYin Changlin

The First Affiliated Hospital of Army Medical University

ycl0315@163.com+86 13983155227

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026