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Evaluation of the effects of synbiotic supplementation on weight gain, fecal ph, acetate, lactate, calprotectin in preterm infants

Protocol summary

Summary
The aim of this study was to evaluate the effect of Lactobacillus plantarum and fructooligosaccharides on weight gain, change the pattern of enteric fermentation and intestinal inflammation in preterm infants in the neonatal intensive care unit in Kamali Hospital of Karaj. Inclusion criteria: all premature infants hospitalized in Kamali Hospital of Karaj and exclusion criteria: in the case of clinical symptoms of Sepsis (including severe lethargy, inability to feed, frequent vomiting, impaired consciousness, seizures, severe abdominal distention , laboratory findings such as positive blood culture and elevated CRP) or critically ill patient for any reason. After determining the population under study, infants were randomly divided into 4 groups: Symbiotic group: this group will received 5 drops of milk fortified with 108 Colony Forming Unit per ml (cfu/ml) of Lactobacillus plantarum and 0.8 grams per dL fructooligosaccharides twice a day for two weeks, probiotics group: this group will received 5 drops of milk fortified with 108 cfu/ml of Lactobacillus plantarum twice a day for two weeks , prebiotic group: this group will received 5 drops of milk fortified with 0.8 grams per dL fructooligosaccharides twice a day for two weeks, control group: this group will received regular milk twice a day for 2 weeks. After two weeks, anthropometric indices including height and weight of babies will be recorded. Also biochemical markers of colonization of probiotic bacteria include acetate, lactate and calprotectin in the stool of infants will be measured. The results of each group will be compared with control and statistically analyzed.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016061128386N1
Registration date: 2016-07-04, 1395/04/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-04, 1395/04/14
Registrant information
Name
Mahboobeh Mehrabani Natanzi
Name of organization / entity
Alborz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6008
Email address
mahboobehmehrabani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research (Alborz University of Medical Sciences)
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of synbiotic supplementation on weight gain, fecal ph, acetate, lactate, calprotectin in preterm infants
Public title
Evaluation of the effects of synbiotic supplementation on weight gain, fecal ph, acetate, lactate, calprotectin in preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Infants weighing less than 2500 g or 37 week; all premature infants hospitalized in Kamali Hospital of Karaj Exclusion criteria: in the case of clinical symptoms of Sepsis (including severe lethargy, inability to feed, frequent vomiting, impaired consciousness, seizures, severe abdominal distention, laboratory findings such as positive blood culture and elevated CRP); critically ill patient for any reason.
Age
To 14 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Table of random numbers.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Alborz University of Medical Sciences
Street address
Faculty of medicine, Golestan 1, Eshteraki, Baghestan, Karaj
City
Karaj
Postal code
Approval date
2016-05-02, 1395/02/13
Ethics committee reference number
abzums.Rec.1395.2

Health conditions studied

1

Description of health condition studied
Preterm infants
ICD-10 code
P78.9
ICD-10 code description
Digestive system disorders of fetus and newborn

Primary outcomes

1

Description
Body Weight
Timepoint
14 days
Method of measurement
weightening for body weight

2

Description
Fecal lactate
Timepoint
14 days
Method of measurement
GC-MASS

3

Description
Fecal calprotectin
Timepoint
14 days
Method of measurement
ELISA kit

4

Description
Fecal acetate
Timepoint
14 days
Method of measurement
GC-MASS

Secondary outcomes

1

Description
Duration of hospitalization in
Timepoint
day of discharge from hospital
Method of measurement
Counting days

Intervention groups

1

Description
Intervention group 1: this group will received 5 drops of milk fortified with 108 Colony Forming Unit per ml (cfu/ml) of Lactobacillus plantarum and 0.8 grams per dL fructooligosaccharides twice a day for two weeks
Category
Treatment - Drugs

2

Description
Intervention 2: this group will received 5 drops of milk fortified with 108 cfu/ml of Lactobacillus plantarum twice a day for two weeks
Category
Treatment - Drugs

3

Description
Intervention 3: this group will received 5 drops of milk fortified with 0.8 grams per dL fructooligosaccharides twice a day for two weeks
Category
Treatment - Drugs

4

Description
Control group: this group will received regular milk twice a day for 2 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamali Hospital
Full name of responsible person
Dr Arezo Hemati
Street address
Kamali Hospital, Shohada square, Karaj
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Alborz University of Medical Sciences
Full name of responsible person
Dr Mohammad Javad Gharavi
Street address
Dara Building, East Pooneh, 45 meters Golshahr, Karaj
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Alborz University of Medical Sciences
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
Alborz University of Medical Sciences
Full name of responsible person
Mahboobeh Mehrabani Natanzi
Position
PhD in biochemistry
Other areas of specialty/work
Street address
Faculty of Medicine, Eshteraki Blvd. Baghestan, Karaj
City
Karaj
Postal code
Phone
+98 26 3458 4919
Fax
Email
mahboobehmehrabani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zohreh Khodaii
Position
PhD in nutrition
Other areas of specialty/work
Street address
Faculty of Medicine, Eshteraki Blvd. Baghestan, Karaj
City
Karaj
Postal code
00982634584919
Phone
+98 26 3458 4919
Fax
Email
zkhidaii@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
khaterh Amini
Position
MSC of food industry
Other areas of specialty/work
Street address
Dara Building, East Pooneh, 45 meters Golshahr, Karaj
City
Karaj
Postal code
Phone
+98 26 3458 4919
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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