Clinical trial · Interventional
Prebiotics in Rectal Cancer
Do Prebiotics Change Intestinal Biome in Rectal Cancer Patients Undergoing Neoadjuvant Therapy
- 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)
A significant racial disparity in the incidence and mortality of CRC exists in the U.S. with African Americans having CRC incidence and mortality rates that are 20% and 40% higher than the general U.S. population. It has been demonstrated that the gut microbiome impacts tumor development and progression through multiple mechanisms, including impacting the tumoral immune response. However, it is unknown if microbiome modulating treatment can have an impact on CRC outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Maltodextrin | Dietary Supplement | — | UNRESOLVED |
| Soluble Corn Fiber | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prebiotic
- description
- Soluble Corn Fiber
- interventionNames
- Dietary Supplement: Soluble Corn Fiber
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Maltodextrin
- interventionNames
- Dietary Supplement: Maltodextrin
Primary outcomes (1)
- measure
- Gut Flora modulation
- timeFrame
- 1 year
- description
- fiber supplements with prebiotic effects modulate the gut and tumor associated microbiome leading to improved outcomes in stage II and III rectal cancer patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 years or older 2. Clinical diagnosis of stage 2 or stage 3 rectal cancer 3. Subjects who are women of child-bearing potential must not be pregnant or lactating 4. Have signed an approved informed consent form for the study 5. Be willing to comply with the protocol Exclusion Criteria: 1. Patients with a cancer history (excluding the rectal cancer currently being addressed) 2. Allergic to corn or maltodextrin 3. Has, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the study
References
Publications (0)
Data not yet available