The purpose of this study was to evaluate the effects of an enteral diet with honey on occurrence of diarrhea, fecal microbiota and outcome of critically ill patients.
In this single center, randomized, controlled double blind study, 32 patients were randomized to receive a high protein kitchen enteral diet which in study group (16 patients) has honey as 5% of its carbohydrate content.Quantitative analyses of bifidobacterium and lactobacillus species of fecal samples were assessed by Real-Time PCR on days 0 and 7. Length of stay in ICU and development of organ failure were also compared in both groups.
General information
Acronym
Honey and Enteral Nutrition
IRCT registration information
IRCT registration number:IRCT2014010514901N3
Registration date:2014-01-22, 1392/11/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-22, 1392/11/02
Registrant information
Name
Zahra Vahdat Shariatpanahi
Name of organization / entity
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7484
Email address
z.shariatpanahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute
Expected recruitment start date
2012-09-01, 1391/06/11
Expected recruitment end date
2013-08-01, 1392/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Honey on Diarrhea and Intestinal Microflora in ICU Patients with Enteral Nutrition
Public title
Enteral Nutrition and Honey
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Age older than 18 years; No history of gastrointestinal disease; No history of Digestive tract surgery; No history of Diabetes; Without Hyperthyroidism
Exclusion criteria: Discharge before 7 days
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods
City
Tehran
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
047478
Health conditions studied
1
Description of health condition studied
Diarrhea
ICD-10 code
K90.8
ICD-10 code description
Other intestinal malabsorption
Primary outcomes
1
Description
Diarrhea
Timepoint
Daily
Method of measurement
Observation
2
Description
fecal microbiota
Timepoint
On days 0 and 7
Method of measurement
Real-time PCR
Secondary outcomes
1
Description
Organ failure
Timepoint
Daily
Method of measurement
Clinical and Paraclinical
2
Description
Duration of hospitalization
Timepoint
Daily
Method of measurement
Observation
Intervention groups
1
Description
Study: honey
5% of total calorie
Category
Treatment - Other
2
Description
Control: None
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tajrish Shohadaa Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr Majid Hajifaraji
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology Research Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nutrition and Food Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Vahdat Shariatpanahi
Position
MD, PhD in nutrition
Other areas of specialty/work
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods,