Clinical trial · Interventional
Dietary Fiber and Probiotics in Advanced Colorectal Cancer
Effects of Combined Dietary Fiber and Probiotic Supplementation on Gut Microbiota, Immune Function, and Clinical Outcomes in Patients With Advanced Colorectal Cancer: A Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (MSI-H) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Malnutrition (Calorie) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined Dietary Fiber and Probiotics. | Dietary Supplement | — | UNRESOLVED |
| Standard Nutritional Support | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Intervention Group
- description
- Patients were randomized to receive standard nutritional support supplemented with a daily combined formulation of dietary fiber and multi-strain probiotics for 12 weeks.
- interventionNames
- Dietary Supplement: Combined Dietary Fiber and Probiotics.
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator: Control Group
- description
- Patients were randomized to receive standard nutritional support alone for 12 weeks.
- interventionNames
- Other: Standard Nutritional Support
Primary outcomes (5)
- measure
- Change in Immunoglobulin A (IgA) level
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available