Clinical trial · Interventional
Modified MAC Diet and Gut Microbiota in CRC Patients
A Modified Microbiota-Accessible Carbohydrates (MAC) Diet and Change of Gut Microbiota in Patients With Colorectal Cancer After Surgery: A Prospective, Open-label, Cross-over, Single Center Study
- 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)
To explore the changes in the composition and diversity of intestinal microbiota during 3-weeks of modified MAC diet and conventional diet in stage I or low-risk stage II colorectal cancer (CRC) patients after surgery. Additionally, the investigator analyze the association of gut microbiota and stool formation pattern or quality of life according to dietary pattern. Therefore, the investigator identify the beneficial or harmful microbiota composition and diversity adapting modified MAC diet that related to cancer recurrence, which provide supporting evidence for future prospective trial.
Conditions
Conditions (3)
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 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Diet Intervention | — | UNRESOLVED | — |
| Gut Microbiota | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modified MAC diet (3-weeks) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- description
- Group 1: Modified MAC diet (first 3-weeks) followed by conventional diet (second 3-weeks)
- interventionNames
- Dietary Supplement: Modified MAC diet (3-weeks)
- type
- PLACEBO_COMPARATOR
- label
- Group 2
- description
- Group 2: Conventional diet (first 3-weeks) followed by modified MAC diet (second 3-weeks)
- interventionNames
- Dietary Supplement: Modified MAC diet (3-weeks)
Primary outcomes (1)
- measure
- The change of gut microbiota diversity
- timeFrame
- Stool sample collection for baseline, after the first 3-week diet, and then after second 3-week diet
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed colorectal adenocarcinoma patients after curative surgery without post-operative chemotherapy (stage I and low-risk stage II) 2. Male of female participants over the age of 19 3. Eastern Cooperative Oncology Group (ECOG) performance score 0-2 4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol 5. Adequate hematologic and end-organ function Exclusion Criteria: 1. Patients with temporary/permanent stoma after surgery 2. Diagnosed with locally advanced stage (more than high-risk stage II) colorectal cancer which require postoperative chemotherapy after surgery 3. Diagnosed with metastatic stage IV colorectal cancer after surgery 4. Uncontrolled diabetes (glycated hemoglobin A1c (HbA1c) \> 8.0 g/dl) 5. Active infection requiring antibiotics, antifungal or antiviral agents or received a course of antibiotics within 4 weeks prior to study treatments 6. Known history of food allergy 7. Known history of uncontrolled intercurrent illness including but not limited to: Infection/inflammation; severe liver dysfunction; bilateral interstitial lung disease; uncontrolled kidney disease; clinically significant (active) cardiovascular and pulmonary disease; hemorrhagic disease; inflammatory bowel disease, intestinal obstruction; Inability to swallow food; social and psychological problems etc.) 8. Other medical and psychiatric conditions that would prohibit the understanding or rendering of informed consent which affect study compliance
References
Publications (0)
Data not yet available