Diarrhea Clinical Trial
Official title:
Intestinal Function of Patients With Colon Neoplasia, Airways and Upper Digestives Subjected to Surgical Treatment: Impact of the Use of Symbiotics
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.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | December 1, 2022 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Ambulatório de Transplantes Hepáticos | Belo Horizonte | MG |
Brazil | Escola de Enfermagem - UFMG | Belo Horizonte | MG |
Lead Sponsor | Collaborator |
---|---|
Federal University of Minas Gerais | Luísa Martins Trindade, Maria Isabel Toulson Davisson Correia, Rodrigo Gomes Silva, Simone de Vasconcelos Generoso |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diarrhea occurrence | Assess the incidence of diarrhea by collecting information on the frequency and consistency of stools. Stool consistency will be classified using the Bristol scale. | Through study completion, an average of 2 years | |
Secondary | Nutritional status | Monitor patients' nutritional status through subjective global assessment, weight, arm circumference, tricipital skinfold and food consumption. | Through study completion, an average of 2 years | |
Secondary | Operative complications | Evaluate operative complications, such as length of hospital stay, need for mechanical ventilation, need for enteral or parenteral nutritional therapy and mortality, through medical records | Through study completion, an average of 2 years |
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