Effect of the Use of Symbiotics in Patients With Colon Cancer

NCT04874883 | Unknown Phase 4 DMC

• 1 other identifier: 24375713.0.0000.5149
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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

Symbiotic; Cancer Colorectal; Cancer Head Neck; Intestinal Dysbiosis; Diarrhea; Intestinal Microbiota; Nutritional Status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Nutritional status

  Through study completion, an average of 2 years

• Operative complications

  Through study completion, an average of 2 years

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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.

Dietary Supplement: Simbyotic

Control Group

PLACEBO COMPARATOR

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

Device: Control Group

Interventions

Simbyotic DIETARY_SUPPLEMENT

6 grams of the symbiotic will be administered twice a day

Intervention Group

Control Group DEVICE

6 grams of the maltodextrin will be administered twice a day

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age, diagnosed with colorectal and head and neck cancer who will undergo a tumor resection operation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Simone de Vasconcelos Generoso: collaborator
• Luísa Martins Trindade: collaborator
• Rodrigo Gomes Silva: collaborator
• Maria Isabel Toulson Davisson Correia: collaborator

Study Sites (2)

Escola de Enfermagem - UFMG

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

Ambulatório de Transplantes Hepáticos

Belo Horizonte, Minas Gerais, Brazil

RECRUITING

Related Publications (1)

• Trindade 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. 2025 Dec 26;145:113080. doi: 10.1016/j.nut.2025.113080. Online ahead of print.

  PMID: 41637916 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Head and Neck Neoplasms; Diarrhea

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Maria Isabel Toulsson Davisson Correia, Doctor

CONTACT

31991688239; isabel_correia@uol.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All individuals directly involved in the research will be masked. The modules used in the study were masked by an individual external to the research, being the only one who knew the composition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: The study will be double-masked and individuals will be randomly divided into two groups: Symbiotic group (S) - will receive the symbiotic (association of fructooligosaccharide, prebiotic, and four probiotic strains: Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus Acidophilus, and Bifidobacterium bifidum) enterally or orally in the amount of a sachet, twice a day. Control Group (C) will receive 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 a sachet. hours until hospital discharge.

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 6, 2021
• Study Start: December 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)