Dietary Fiber and Probiotics in Advanced Colorectal Cancer (NCT07194954) | Clinical Trial Compass
CompletedNot Applicable
Dietary Fiber and Probiotics in Advanced Colorectal Cancer
China80 participantsStarted 2022-05-01
Plain-language summary
This single-center, prospective, randomized controlled trial was conducted to evaluate the efficacy of a 12-week combined dietary fiber and probiotic supplementation on gut microbiota, immune function, nutritional status, and survival outcomes in malnourished patients with advanced colorectal cancer undergoing conventional therapy, compared to standard nutritional support alone.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pathologically confirmed diagnosis of stage II-IV colorectal cancer post-resection.
* Receiving active adjuvant chemotherapy.
* Documented moderate-to-severe malnutrition (PG-SGA score ≥ 4).
* Ability to tolerate oral intake.
* Voluntarily signed the informed consent form.
Exclusion Criteria:
* Presence of complete bowel obstruction.
* Severe, uncontrolled organ dysfunction (cardiac, hepatic, renal).
* Known allergy to any component of the nutritional supplements.
* Concurrent participation in another interventional trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Immunoglobulin A (IgA) level
Timeframe: Baseline and 12 weeks
2
Change in Immunoglobulin G (IgG) level
Timeframe: Baseline and 12 weeks
3
Change in CD4+/CD8+ T-lymphocyte ratio
Timeframe: Baseline and 12 weeks
4
Change in Gut Microbiota Alpha Diversity
Timeframe: Baseline and 12 weeks
5
Change in Relative Abundance of Probiotics
Timeframe: Baseline and 12 weeks
Trial details
NCT IDNCT07194954
SponsorThe First Hospital of Hebei Medical University