1. Home
  2. Approved trials
  3. » فارسی

Synbiotic preparation containing Lactobacillus Spp., Bifidobacter Spp. and Fructo-oligo-saccharide in alleviating constipation symptoms in young men suffering from functional constiption

Protocol summary

Summary
The objective of this study is to evaluate the effectiveness of Synbiotic preparation containing 108 CFU of Lactobacillus spp., Bifidobacter spp., S.Thermophilus and Prebiotic: Fructooligosaccharide (commercial name: Protexin, London, UK) on constipation symptoms in young men suffering from functional constipation. 66 young men suffering from functional constipation were included (by screening population of young men) in a randomized clinical trial, of whom 60 (Intervention: 31, placebo: 29) completed study period. Functional constipation was defined by Rome 3 criteria. Patients with systemic disorders, fever, recent weight loss, LAP, anemia, Diabetes Mellitus, nervous system disorder, or history of gastrointestinal surgery were excluded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138802151873N1
Registration date: 2009-06-10, 1388/03/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-06-10, 1388/03/20
Registrant information
Name
Rouzbeh Fateh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2242 7617
Email address
rouzbehfateh@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Aja Universiy of Medical Sciences, research committee
Expected recruitment start date
2008-05-10, 1387/02/21
Expected recruitment end date
2009-03-11, 1387/12/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Synbiotic preparation containing Lactobacillus Spp., Bifidobacter Spp. and Fructo-oligo-saccharide in alleviating constipation symptoms in young men suffering from functional constiption
Public title
Synbiotic preparation in young men suffering from functional constipation, a randomized clinical trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male sex, age 18-40 years, Fulfill Rome III criteria, giving informed consent Exclusion criteria: Presence of alarming symptoms like fever, recent weight loss, LAP, anemia, presence of any systemic disorder like Diabetes Mellitus or nervous system disorder like M.S., history of gastrointestinal surgery
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization was done with block method.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Aja University of Medical Sciences ethics committee
Street address
Aja University of Medical Sciences, Fatemi ave.
City
Tehran
Postal code
14185/611
Approval date
2008-05-01, 1387/02/12
Ethics committee reference number
20/ 1 / 9158 / 1ج /الف

Health conditions studied

1

Description of health condition studied
functional constipation
ICD-10 code
K59.0
ICD-10 code description
other functional intestinal disorders-constipation

Primary outcomes

1

Description
Stool form and consistency
Timepoint
Baseline, weeks 2 and 4
Method of measurement
Bristol stool form scale

2

Description
Bowel movement frequency per week
Timepoint
Baseline, weeks 2 and 4
Method of measurement
Designed questionnaire

3

Description
Severity of constipation symptoms
Timepoint
Baseline, weeks 2 and 4
Method of measurement
PAS-sym questionnaire

Secondary outcomes

1

Description
Effectiveness of treatment
Timepoint
Baseline and week 4
Method of measurement
Designed questionnaire

2

Description
Need to use manual maneuvres
Timepoint
Baseline and week 4
Method of measurement
Designed questionnaire

3

Description
Use of laxatives
Timepoint
Baseline and week 4
Method of measurement
Designed questionnaire

Intervention groups

1

Description
Intervention group: Synbiotic capsule, containing 108 CFU of Lactobacillus spp., Bifidobacter spp., S.Thermophilus and Prebiotic: Fructooligosaccharide (commercial name: Protexin, London, UK), twice a day (after breakfast and after dinner) for 4 weeks
Category
Treatment - Drugs

2

Description
Control group: placebo capsule with the same shape and color, twice a day (after breakfast and after dinner) for 4 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
501 hospital and AJA University of Medical Sciences
Full name of responsible person
Ms. Roshandel
Street address
501 hospital, Fatemi Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Aja University of Medical Sciences
Full name of responsible person
Dr. Dorrmanesh
Street address
Aja University of Medical Sciences, Fatemi ave.
City
Tehran
Grant name
230 / 111200
Grant code / Reference number
10514300
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Aja 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
Tehran University of Medical Sciences
Full name of responsible person
Rouzbeh Fateh
Position
M.D.
Other areas of specialty/work
Street address
no.18, Keyhan st., Moghaddas Ardebili Ave., Zafaranieh
City
Tehran
Postal code
19868-73613
Phone
+98 21 2242 7617
Fax
+98 21 2242 7980
Email
rouzbehfateh@student.tums.ac.ir / rouzfa@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rouzbeh Fateh
Position
M.D.
Other areas of specialty/work
Street address
no.18, Keyhan st. Moghaddas Ardebili ave. Zafaranieh
City
Tehran
Postal code
19868-73613
Phone
+98 21 2242 7617
Fax
+98 21 2242 7980
Email
rouzbehfateh@student.tums.ac.ir / rouzfa@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rouzbeh Fateh
Position
M.D.
Other areas of specialty/work
Street address
no.18, Keyhan st. Moghaddas Ardebili ave. Zafaranieh
City
Tehran
Postal code
19868-73613
Phone
+98 21 2242 7617
Fax
+98 21 2242 7980
Email
rouzbehfateh@student.tums.ac.ir / rouzfa@yahoo.com
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
Loading...