Effect of the Use of Symbiotics in Patients With Colon Cancer
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ClinicalTrials.gov Identifier: NCT04874883 |
Recruitment Status : Unknown
Verified April 2021 by Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais.
Recruitment status was: Recruiting
First Posted : May 6, 2021
Last Update Posted : May 6, 2021
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Condition or disease | Intervention/treatment | Phase |
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Symbiotic Cancer Colorectal Cancer Head Neck Intestinal Dysbiosis Diarrhea Intestinal Microbiota Nutritional Status | Dietary Supplement: Simbyotic Device: Control Group | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Prevention |
Official Title: | Intestinal Function of Patients With Colon Neoplasia, Airways and Upper Digestives Subjected to Surgical Treatment: Impact of the Use of Symbiotics |
Actual Study Start Date : | December 1, 2019 |
Estimated Primary Completion Date : | December 1, 2022 |
Estimated Study Completion Date : | December 1, 2022 |
Arm | Intervention/treatment |
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Active Comparator: Intervention Group
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.
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Dietary Supplement: Simbyotic
6 grams of the symbiotic will be administered twice a day |
Placebo Comparator: Control Group
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
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Device: Control Group
6 grams of the maltodextrin will be administered twice a day |
- Diarrhea occurrence [ Time Frame: Through study completion, an average of 2 years ]Assess the incidence of diarrhea by collecting information on the frequency and consistency of stools. Stool consistency will be classified using the Bristol scale.
- Nutritional status [ Time Frame: Through study completion, an average of 2 years ]Monitor patients' nutritional status through subjective global assessment, weight, arm circumference, tricipital skinfold and food consumption.
- Operative complications [ Time Frame: Through study completion, an average of 2 years ]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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04874883
Contact: Maria Isabel Toulsson Davisson Correia, Doctor | 31991688239 | isabel_correia@uol.com.br |
Brazil | |
Escola de Enfermagem - UFMG | Recruiting |
Belo Horizonte, MG, Brazil, 30130-100 | |
Contact: Simone V Generoso 988128650 ext +55(31) simonenutufmg@gmail.com | |
Ambulatório de Transplantes Hepáticos | Recruiting |
Belo Horizonte, MG, Brazil | |
Contact: Maria Isabel TD Correia, MD, PhD 553191688239 isabel_correia@uol.com.br | |
Principal Investigator: Maria Isabel TD Correia, MD, PhD |
Responsible Party: | Maria Isabel Toulson Davisson Correia, Sponsor-Investigator, Federal University of Minas Gerais |
ClinicalTrials.gov Identifier: | NCT04874883 |
Other Study ID Numbers: |
24375713.0.0000.5149 |
First Posted: | May 6, 2021 Key Record Dates |
Last Update Posted: | May 6, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Head and Neck Neoplasms Diarrhea Dysbiosis Signs and Symptoms, Digestive |
Pathologic Processes Neoplasms by Site Neoplasms |