Protocol summary

Study aim
Evaluate the effect of Lactobasili on reducing the pain associated with endometriosis
Design
In this pragmatic, community based, parallel group, triple-blind, randomisd controlled trial, 30 patients with endometriosis referring to Rasoul-e-Akram Hospital who are eligible for entering the study are enrolled. Patients are randomly allocated into two groups: intervention and control groups; and each participant will be assigned a code.
Settings and conduct
In this clinical trial study, all patients who underwent laparoscopic surgery in Rasool Akram Hospital and have proven endometriosis make the study population. Then, the patients enter the study according to the inclusion and exclusion criteria and after getting written consent. This study is designed triple-blind (patients, interventionist, analyst) , and only an observer will be informed of the groupings.
Participants/Inclusion and exclusion criteria
Major Inclusion Criteria: 1) Definitive diagnosis of endometriosis; 2)Menstrual cycle in the range of 21-35 days; 3) Aged 18-45 years; 4) Those who had VAS Score intensity of 5 or more for their pain intensity; 5) Passing at least 3 months and 1 year at the most since surgery Major Exclusion Criteria: 1) Patients who had received hormonal treatment during the past 3 months; 2) History of liver or renal disease; 3) history of carcinoma; 4) Patients with history of diarrhea after consuming dairy products; 5) Consumption of food or any type of probiotic product; 6) Those who had a pain intensity of less than 5 according to the VAS Score.
Intervention groups
Group 1: Placebo treatment: 1 palcebo tablets daily as a control group Group 2: Daily treatment of once daily lactobasili tablets
Main outcome variables
severity of dysmenorrhea severity of chronic pelvic pain severity of dyspareunia total VAS score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150819023684N5
Registration date: 2018-04-17, 1397/01/28
Registration timing: retrospective

Last update: 2018-04-17, 1397/01/28
Update count: 0
Registration date
2018-04-17, 1397/01/28
Registrant information
Name
Sepideh Khodaverdi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2562
Email address
khodaverdi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran University of Medical Sciences (Primary sponsor) Zist Takhmir Pharmaceutical Company
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
2016-12-10, 1395/09/20
Actual recruitment end date
2017-09-21, 1396/06/30
Trial completion date
empty
Scientific title
Evaluation of the Effect of Administration of Lactobacilli on Pain Relief in Endometriosis
Public title
Evaluation of the Effect of Lactobacilli on Pain Relief in Endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of endometriosis Menstrual cycle in the range of 21-35 days Aged 18-45 years Those who had VAS (Visual Analogue Scale) Score intensity of 5 or more for their pain intensity Passing at least 3 months and 1 year at the most since surgery
Exclusion criteria:
Patients who had received hormonal treatment during the past 3 months History of liver or renal disease history of carcinoma Patients with history of diarrhea after consuming dairy products Consumption of food or any type of probiotic product Those who had a pain intensity of less than 5 according to the VAS Score Patients who had received antibiotics during the past 3 months
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple random method was used for Randomization with using random numbers table. for allocations concealment, individuals outside the study were used for random allocation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is designed triple -blind, so that the researcher, subject and statistical analyst are not aware of the status of the allocation of the two groups. Because the administration of the drug and placebo happens under the exactly same appearance, therefore, the subject is not aware of the assignment of the groups. The researcher measuring clinical and diagnostic measures is not aware of the status of the individual, and the statistician is also unaware of the allocation of people to study groups. Only the observer is aware of the allocation of the groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2016-12-04, 1395/09/14
Ethics committee reference number
IR.IUMS.REC 1395.9311290013

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis

Primary outcomes

1

Description
Mean VAS score
Timepoint
8 and 12 weeks after starting of drug use
Method of measurement
VAS Questionnaire

Secondary outcomes

1

Description
Drug Adverse Effects
Timepoint
8 and 12 Weeks after starting drug use
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention Group: Lactobacilli tablets, once daily with the trade name "Lactofem" from Zist Takhmir Pharmaceutical Company which contains 10 to the power 9 colony count of the following lactobacilli: Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus fermentum, Lactobacillus gasseri. The tablet will be taken for 8 weeks and the patient will be evaluated after 8 and 12 weeks after the beginning of the treatment.
Category
Treatment - Drugs

2

Description
Control group: Placebo treatment; daily 1 tablet of the placebo which is made by the pharmaceutical company Zist Takhmir with the exactly same packaging and appearance with "Lactofem". The tablet will be taken for 8 weeks and the patient will be evaluated after 8 and 12 weeks after the beginning of the treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul- E - Akram Hospital
Full name of responsible person
Dr. Sepideh Khodaverdi
Street address
Rasoul- E - Akram Hospital, Niayesh Avenue, Sattarkhan Street, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Email
sepidehkhodaverdi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Malakooti
Street address
Vice Chancellor for Research, Iran University of Medical Sciences, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Sepideh Khodaverdi
Position
Assistant Professor, Fellowship in Minimally Invasive Gynecologic Surgery
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasool Akram Hospital. Niayesh St. Sattarkhan Street. Rasool Akram Hospital, Department of Obstetrics and Gynecology, Endometriosis Research Center.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Fax
Email
sepidehkhodaverdi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran university of medical science
Full name of responsible person
Dr. Sepideh Khodaverdi
Position
Assistant professor, Fellowship in Minimally Invasive Gynecologic Surgery
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasool Akram Hospital, Niayesh Avenue, Sattarkhan Street.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Fax
Email
sepidehkhodaverdi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Sepideh Khodaverdi
Position
Assistant Professor, Fellowship in Minimally Invasive Gynecologic Surgery
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasool Akram Hospital، Department of Obstetrics and Gynecology، Endometriosis Research Center
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Fax
Email
sepidehkhodaverdi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data except personal information
When the data will become available and for how long
After publication of Paper
To whom data/document is available
Researchers working in research and academic centers
Under which criteria data/document could be used
further research
From where data/document is obtainable
Dr. Khodaverdi
What processes are involved for a request to access data/document
Request via email
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