Protocol summary

Summary
Objectives: The aim of this study is to investigate the effect of synbiotics (composition of Bifidobacterium and Lactobacillus and complex fiber), probiotic (Bifidobacterium and Lactobacillus) and placebo supplementation on renal function (GFR), systemic (hs-CRP, IL-6 ) and vascular (ICAM-1 and VCAM-1) inflammations, endotoxin, HSP 70 antibody and cytokeratin 18 (k-18) in hemodialysis patients design: In this double-blind randomized controlled trial, 75 male and female hemodialysis patients aged 65-30 years old, who are eligible for inclusion in the study will be recruited from hemodialysis ward of Ahwaz Imam Khomeini hospital. After obtaining Informed consent form all participants at the beginning of the study, Participants randomly allocated in three groups, receiving daily supplementation of synbiotics, probiotics or placebo for 8 weeks. Before starting dialysis, Blood and stool samples will be collected at the beginning and end of study. All anthropometric and physical activity variables will be measured both before and after the trial. To assess the dietary factors, the total amount of energy, macronutrients and micronutrients intake will be determined at the beginning and the end of the study. For this purpose 3-days 24-hour dietary recall will be completed by the patients and will be evaluated. Finally data will be analyzed by N4 software. Diets and medications dosage will be held constant throughout the study and each subject’s exercise level will be kept constant and monitored by physical activity questionnaires (IPAQ).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041233393N1
Registration date: 2017-04-23, 1396/02/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-23, 1396/02/03
Registrant information
Name
Neda Haghighat
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 705 0021
Email address
haghighat.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Synbiotics and Probiotics supplementation on renal function, systemic and vascular inflammations, heat shock protein 70 Antibody (HSP70) and cytokeratin-18 (k-18) in hemodialysis patients
Public title
The effect of Synbiotics and Probiotics supplementation in reducing cardiovascular complications in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria were: willingness to cooperate; at least 3 months renal failure on hemodialysis, 4 hours hemodialysis three times a week; aged between 65-30 years Exclusion criteria: history of kidney transplantation; infection; history of hospitalization in the last month; useing any products or supplements containing probiotics and prebiotics and antibiotics in 1 months; using vitamins fiber omega-3 antioxidants within 3 weeks before or during the study; using nonsteroidal anti-inflammatory drug NSAIDs; progesterone, immunosuppressive drugs; diuretics and corticosteroids; the radiation in the area of small and large bowel; with Being irritable bowel syndrome; Crohn's disease or ulcerative colitis; a severe malnutrition (SGA: C); swelling and bloating
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Ethics Committee
City
Ahvaz
Postal code
15794-61357
Approval date
2017-02-25, 1395/12/07
Ethics committee reference number
IR.AJUMF.REC.1395.812

Health conditions studied

1

Description of health condition studied
hemoldialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis

Primary outcomes

1

Description
َAntibody HSP70
Timepoint
at first and two months after intervention
Method of measurement
ELISA

2

Description
Interleukin -6
Timepoint
at first and two months after intervention
Method of measurement
ELISA

3

Description
ICAM-1
Timepoint
at first and two months after intervention
Method of measurement
ELISA

4

Description
VCAM-1
Timepoint
at first and two months after intervention
Method of measurement
ELISA

5

Description
Cytokeratin-18
Timepoint
at first and two months after intervention
Method of measurement
ELISA

6

Description
Endotoxin
Timepoint
at first and two months after intervention
Method of measurement
ELISA

7

Description
BUN
Timepoint
at first and two months after intervention
Method of measurement
Enzymatic

8

Description
keratinin
Timepoint
at first and two months after intervention
Method of measurement
Enzymatic

9

Description
hs-CRP
Timepoint
at first and two months after intervention
Method of measurement
ELISA

10

Description
The number of Lactobacillus colonies
Timepoint
at first and two months after intervention
Method of measurement
dilution

11

Description
The number of bifidobacter colonies
Timepoint
at first and two months after intervention
Method of measurement
dilution

Secondary outcomes

empty

Intervention groups

1

Description
Probiotics supplementation with one 5 gr Probiotics saches (105 bifidobacter and lactobacilus) and two 5 gr sache of maltodextrin
Category
Prevention

2

Description
Synbiotics supplementation with two 5 gr sache of prebiotics (FOS, GOS, Inulin) and one 5 gr sache of probiotics (105 lactobasilus, bifidobacter)
Category
Prevention

3

Description
Placebo cantaining three 5 gr saches of maltodextrin
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
hemodialysis center
Full name of responsible person
Dr Shaianfar
Street address
Emam khomeini hospital
City
ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr Makhmalzade
Street address
Vice chancellor for research, Ahvaz Jundishapur University of Medical Science, Ahvaz, Khouzestan
City
Ahvaz
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, Ahvaz Jundishapour 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
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Neda Haghighat
Position
Ph.D Candidate of Nutrition Science
Other areas of specialty/work
Street address
Dept of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science, Ahvaz, Khouzestan
City
Ahvaz
Postal code
Phone
+98 61 3373 8330
Fax
Email
haghighat.n@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Majid Mohammad Shahi
Position
Associate Professor
Other areas of specialty/work
Street address
Dept of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science,Golestan Ave, Ahvaz,Khouzestan
City
Ahvaz
Postal code
Phone
+98 61 3373 8330
Fax
Email
shahi334@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Neda Haghighat
Position
Phd Candidate of Nutrition Science
Other areas of specialty/work
Street address
Dept of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Postal code
Phone
+98 61 3373 8330
Fax
Email
haghighat.n@ajums.ac.ir
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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