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Trial record 51 of 592 for:    maltodextrin

Impact of Symbiotic Administration on Intestinal Function of Head and Neck Patients Surgically Treated

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ClinicalTrials.gov Identifier: NCT02654652
Recruitment Status : Completed
First Posted : January 13, 2016
Results First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Conditions Head and Neck Cancer
Synbiotics
Nutrition Therapy
Interventions Dietary Supplement: Symbiotic
Dietary Supplement: Maltodextrin
Enrollment 40
Recruitment Details This study enrolled patients hospitalized with head and neck cancer from Instituto Alfa de Gastroenterologia, Hospital das Clínicas de Minas Gerais, from October 2014 until April 2016
Pre-assignment Details Of the 40 patients screened, six were ineligible: esophageal cancer (1), cirrhosis (1) and four were inoperable. Forty were randomized (19 - symbiotic group and 21 - control)
Arm/Group Title Symbiotic Maltodextrin
Hide Arm/Group Description

Patients will receive twice a day the symbiotic product during seven days after surgical treatment

LactoFos: Patients will receive the product twice a day during seven days after surgical treatment

Patients will receive twice a day the placebo product during seven days after surgical treatment

Maltodextrin: Patients will receive maltodextrin twice a day during seven days after surgical treatment

Period Title: Overall Study
Started 19 21
Completed 18 18
Not Completed 1 3
Arm/Group Title Symbiotic Maltodextrin Total
Hide Arm/Group Description Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days. Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days. Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  66.7%
10
  55.6%
22
  61.1%
>=65 years
6
  33.3%
8
  44.4%
14
  38.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
5
  27.8%
2
  11.1%
7
  19.4%
Male
13
  72.2%
16
  88.9%
29
  80.6%
Nutritional status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Nourished
6
  33.3%
8
  44.4%
14
  38.9%
Malnourished
12
  66.7%
10
  55.6%
22
  61.1%
[1]
Measure Description: According to Detsky et al, 1987
1.Primary Outcome
Title Serum DAO Enzyme Concentration
Hide Description The intestinal permeability using serum DAO enzyme concentration (ng/mL) was determined by sandwich enzyme-linked immunosorbent assay (ELISA) kit (SEA656Hu), according to Cloud-Clone Corporation® (Huston, TX) specifications.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbiotic Maltodextrin
Hide Arm/Group Description:
Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days.
Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days.
Overall Number of Participants Analyzed 18 18
Median (Full Range)
Unit of Measure: ng/mL
3
(0 to 7)
2.5
(0 to 6)
2.Secondary Outcome
Title Infection Rate
Hide Description According to Dindo et al, 2004
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbiotic Maltodextrin
Hide Arm/Group Description:
Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days.
Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days.
Overall Number of Participants Analyzed 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
11
  61.1%
7
  38.9%
Time Frame 30 days
Adverse Event Reporting Description All-cause Mortality
 
Arm/Group Title Symbiotic Maltodextrin
Hide Arm/Group Description Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days. Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days.
All-Cause Mortality
Symbiotic Maltodextrin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symbiotic Maltodextrin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Symbiotic Maltodextrin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Maria Isabel Correia
Organization: Universidade Federal de Minas Gerais
Phone: +55 31 34098033
EMail: isabel_correia@uol.com.br
Layout table for additonal information
Responsible Party: Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02654652     History of Changes
Other Study ID Numbers: CAAE 24375713.0.0000.5149
First Submitted: January 7, 2016
First Posted: January 13, 2016
Results First Submitted: November 14, 2016
Results First Posted: June 5, 2019
Last Update Posted: June 5, 2019