Clinical trial · Interventional
Concentrated Complex Plant Dietary Elements for Chemotherapy-Induced Diarrhea
Concentrated Complex Plant Dietary Elements for Chemotherapy-Induced Diarrhea: a Phase II Open-label, Single-arm Study
NCT07460596CI-TRIAL-00105180completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Chemotherapy-induced diarrhea (CID) is common in patients with gastrointestinal cancer. We evaluated whether the concentrated phytodietary compound (hereafter referred to as CPC) as a nutritional adjuvant to routine anti-diarrheal treatment, acts to alleviate CID in a phase II open-label, single-arm study.
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 |
|---|---|---|---|
| Colon and Rectal Cancer | — | UNRESOLVED | — |
| Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concentrated Phytodietary Compound | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Group 1
- interventionNames
- Dietary Supplement: Concentrated Phytodietary Compound
Primary outcomes (2)
- measure
- clinical cure rate of diarrhea
- timeFrame
- During the first 7 days after CPC administration, record daily the number of bowel movements, stool consistency, gastrointestinal symptoms, BSS score, and the amount of antidiarrheal medications used, such as loperamide and montmorillonite powder.
- description
- Clinical cure of diarrhea was defined as two consecutive normal solid stool movements or no stool movements within 12 hours after CPC administration.
- measure
- 7-day clinical cure rate
- timeFrame
- Clinical cure of diarrhea was defined as two consecutive normal solid stool movements or no stool movements within 12 hours after CPC administration.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1、Age ≥ 18 years; 2、Patients with gastrointestinal tumors currently receiving chemotherapy with irinotecan or fluorouracil agents; 3、Experienced diarrhea after previous chemotherapy and recovered after treatment; 4、Experienced diarrhea again after this course of chemotherapy; 5、Adequate organ function. Exclusion Criteria： 1、Allergic to foods such as taro, rice, or carrots; 2、Diarrhea after previous chemotherapy not cured; 3、Patients unable to eat orally; 4、Patients with severe mental illness; 5、Patients who cannot cooperate well.
References
Publications (0)
Data not yet available
No reference posted for this study.