Clinical trial · Interventional
Effect of the Use of Symbiotics in Patients With Colon Cancer
Intestinal Function of Patients With Colon Neoplasia, Airways and Upper Digestives Subjected to Surgical Treatment: Impact of the Use of Symbiotics
- 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)
Due to the high incidence, cancer and the concomitant presence of malnutrition are currently a worldwide public health problem. The loss of weight and body tissues is a common condition in cancer patients with lesions of the airways and digestive tract and is related to anorexia and the presence and duration of gastrointestinal symptoms, such as diarrhea. The latter directly interferes with the progression of enteral diets, which are administered in order to provide adequate nutritional support for the recovery of patients and nutritional status. In this sense, the importance of measures to help reduce diarrhea episodes is reinforced, aiming at the adequate infusion of enteral diets and, consequently, nutritional needs. It is known that the use of antimicrobials is closely related to the increased incidence of nasocomial diarrhea, as it facilitates colonization by pathogenic bacteria, such as Clostridium difficile. In addition, nosocomial diarrhea is a very relevant occurrence due to the financial burden it causes for the hospital institution, which can also worsen the patient's clinical condition, since he is weakened due to the underlying disease. Despite these important aspects, studies carried out with the aim of reducing diarrhea episodes in patients with airway and digestive lesions are still not described in the literature. In this context, the use of symbiotics presents itself as a possibly beneficial alternative, considering the role of probiotics and prebiotics in the modulation of intestinal function. In this sense, this work aims to evaluate the impact of perioperative supplementation with symbiotic on clinical outcomes and intestinal function of patients with colon cancer and digestive airways undergoing colorectal resection. It is assumed that the use of symbiotics could have better results than the use of probiotics and isolated prebiotics.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Colorectal | — | UNRESOLVED | — |
| Cancer Head Neck | — | UNRESOLVED | — |
| Diarrhea | — | UNRESOLVED | — |
| Intestinal Dysbiosis | — | UNRESOLVED | — |
| Intestinal Microbiota | — | UNRESOLVED | — |
| Nutritional Status | — | UNRESOLVED | — |
| Symbiotic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Group | Device | — | UNRESOLVED |
| Simbyotic | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention Group
- description
- You will receive 6 grams of the symbiotic (association of fructooligosaccharides, prebiotics, and four probiotic strains: Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus Acidophilus, and Bifidobacterium bifidum) either enterally or twice a day.
- interventionNames
- Dietary Supplement: Simbyotic
- type
- PLACEBO_COMPARATOR
- label
- Control Group
- description
- Will receive 6 grams of the maltodextrin placebo (carbohydrate easily absorbed and digested, not fermented by colonic bacteria and which does not interfere in the microbial ecology of the gastrointestinal tract or in the metabolism and function of the intestine), either enterally or orally in two sachets times a day
- interventionNames
- Device: Control Group
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years of age, diagnosed with colorectal and head and neck cancer who will undergo a tumor resection operation Exclusion Criteria: * Individuals who have inflammatory bowel diseases will be excluded; have previously undergone operations on the gastrointestinal tract; have used antibiotics, prebiotics, probiotics or symbiotics in the last 15 days and are on an enteral fiber diet.
References
Publications (1)
- DERIVEDTrindade LM, Borges AD, Carvalho RDO, Gomes BF, da Silva MT, Sette NSV, Rogerio L, Cavalcanti GG, Garcia APV, Cassali GD, Azevedo VA, Cardoso VN, Mauricio SF, Rodrigues LB, Valdes ST, da Silva RG, Generoso SV. Preoperative symbiotic supplementation modulates the intestinal microbiota of patients with colorectal cancer: Evidence from a randomized clinical trial. Nutrition. 2026 May;145:113080. doi: 10.1016/j.nut.2025.113080. Epub 2025 Dec 26. PMID 41637916