Trial Outcomes & Findings for Impact of Symbiotic Administration on Intestinal Function of Head and Neck Patients Surgically Treated (NCT NCT02654652)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

7 days

Results posted on

2019-06-05

Participant Flow

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

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)

Participant milestones

Participant milestones
Measure	Symbiotic 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	Maltodextrin 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
Overall Study STARTED	19	21
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Symbiotic n=18 Participants Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days.	Maltodextrin n=18 Participants Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Nutritional status Nourished	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Nutritional status Malnourished	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

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.

Outcome measures

Outcome measures
Measure	Symbiotic n=18 Participants Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days.	Maltodextrin n=18 Participants Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days.
Serum DAO Enzyme Concentration	3 ng/mL Interval 0.0 to 7.0	2.5 ng/mL Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 7 days

According to Dindo et al, 2004

Outcome measures

Outcome measures
Measure	Symbiotic n=18 Participants Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days.	Maltodextrin n=18 Participants Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days.
Infection Rate	11 Participants	7 Participants

Adverse Events

Symbiotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Maltodextrin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Maria Isabel Correia

Universidade Federal de Minas Gerais

Phone: +55 31 34098033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place