Investigating the effect of Streptococcus thermophilus, Lactiplantibacillus plantarum and the combination of these two probiotics on uremic pruritus in patients undergoing hemodialysis : A double-blind randomized clinical trial
Investigating the effect of probiotics on uremic pruritus in patients under hemodialysis.
Design
clinical trial with control group, parallel, double-blinded, and randomized, phase 3 on 56 patients(each group 14). Initially, block randomization will be performed. The four study groups will include :1.Placebo maltodextrin2.Lactiplantibacillus plantarum 3.Streptococcus Thermophilus 4.Combination of two probiotic.
Settings and conduct
Patients at dialysis centers affiliated with Shiraz University of Medical Sciences will be studied in a double-blind manner. The drugs and placebo will be provided to the nurse in similar packaging based on block randomization and will be distributed according to their numbers and the patient list. The patients and the researcher responsible for data collection will have no knowledge of the contents of the packages. To assess itching, the visual analog scale method and the Persian version of the 5-D itch questionnaire will be used,to assess the quality of life of skin patients, the Persian version of the Dermatology Quality of Life Index questionnaire will be used. Serum levels of C-reactive protein and interleukin-6 will be measured before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: more than three months of continuous hemodialysis with at least 6 weeks of itching. Exclusion criteria: active cancer or infection, pregnancy, or sensitivity to probiotics.
Intervention groups
1.patients with uremic pruritus receiving the maltodextrin placebo.
2.patients with uremic pruritus receiving the probiotic Lactiplantibacillus Plantarum.
3.patients with uremic pruritus receiving the probiotic Streptococcus Thermophilus.
4.patients with uremic pruritus receiving the combined two probiotics mentioned above.
Main outcome variables
severity of itching;quality of life score; serum levels of interlukine-6 and C-reactive protein
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201005048927N1
Registration date:2025-04-27, 1404/02/07
Registration timing:registered_while_recruiting
Last update:2025-04-27, 1404/02/07
Update count:0
Registration date
2025-04-27, 1404/02/07
Registrant information
Name
Maryam Shafiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 2767
Email address
m_shafiee@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-21, 1404/01/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Streptococcus thermophilus, Lactiplantibacillus plantarum and the combination of these two probiotics on uremic pruritus in patients undergoing hemodialysis : A double-blind randomized clinical trial
Public title
Investigating the effect of probiotic supplements on uremic pruritus in patients undergoing hemodialysis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Continuous hemodialysis for more than three months
They should have suffered from itching for at least 6 weeks.
Exclusion criteria:
Liver disease
History of seizures
Skin disease associated with itching
Hemolytic blood disease
First complaint of itching
Use of any type of antibiotic
Participation in another clinical trial in the past month
pregnancy
active cancer
Active infection
Sensitivity to probiotic compounds
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, block randomization will be conducted. Grouping of patients will be carried out in a double-blind manner. The drugs and placebo will be provided to the dialysis unit nurse in similar packaging (labeled with numbers one to four) based on block randomization, and they will not be aware of the contents of the packages. Based on the numbers and the patient list, they will distribute the drugs and placebo among the patients, who will also be unaware of the contents of the packages. On the other hand, data collection will be performed by another researcher who has not been involved in the patient allocation process from the beginning and is unaware of it.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants (the form of the drug in the control group and the three intervention groups are selected to be completely identical in terms of appearance and method of consumption), nurses in the dialysis unit who distribute the medication, a researcher who completes the questionnaires, a researcher who collects data related to patients such as information related to the dialysis records of patients, a researcher who conducts the tests.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical science
Street address
Shiraz, Zand Street, opposite Palestine Street, Central Building of Shiraz University of Medical Sciences.
City
Shiraz
Province
Fars
Postal code
71348-14333
Approval date
2025-03-15, 1403/12/25
Ethics committee reference number
IR.SUMS.MED.REC.1403.816
Health conditions studied
1
Description of health condition studied
chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
2
Description of health condition studied
uremic pruritus
ICD-10 code
L29.9
ICD-10 code description
Pruritus, unspecified
Primary outcomes
1
Description
uremic pruritus( method of Scale Analogue Visual and the Persian version of the 5-Scale Itching Questionnaire)
Timepoint
At the beginning of the study (before the intervention starts), during the intervention (6 weeks after the intervention starts), and after the intervention (immediately after 12 weeks from the start of the intervention).
Method of measurement
To assess itching, the Scale Analogue Visual method and the Persian version of the 5-Scale Itching Questionnaire, whose validity and reliability have been confirmed by Yousef Nejad, will be used
Secondary outcomes
1
Description
C-REACTIVE PROTEIN
Timepoint
At the beginning of the study (before the intervention starts) and at the end of the intervention (after completing 12 weeks).
Method of measurement
ELISA
2
Description
Interlukine-6
Timepoint
At the beginning of the study (before the intervention starts) and at the end of the intervention (after completing 12 weeks).
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group:Lactiplantibacillus plantarum group: Oral medication in the form of drops equivalent to CFU=1*109 of Lactiplantibacillus plantarum bacteria administered daily for 12 weeks.Probiotics are prepared by Pardis Roshd Company under the supervision of a food industry specialist.
Category
Treatment - Drugs
2
Description
Intervention group: Thermophilous Streptococcus group: Oral medication in the form of drops equivalent to CFU=1*109 of Thermophilous Streptococcus bacteria administered daily for 12 weeks. Probiotics are prepared by Pardis Roshd Company under the supervision of a food industry specialist.
Category
Treatment - Devices
3
Description
Intervention group:Oral medication in the form of drops equivalent to CFU=28 109 evenly from Lactiplantibacillus plantarum and Thermophilous Streptococcus bacteria administered daily for 12 weeks. Probiotics are prepared by Pardis Roshd Company under the supervision of a food industry specialist.
Category
Treatment - Drugs
4
Description
Control group: Oral medication in the form of drops (placebo) with maltodextrin administered daily for 12 weeks. Prepared by Pardis Roshd Company under the supervision of a food industry specialist.