A randomized double blind clinical trial evaluating the effect of Colchicine & Probiotics mixture on Colon Transient Time in patient with idiopathic constipation
* Goals:
- A randomized double blind clinical trial evaluating the effect of Colchicine & Probiotics mixture on Colon Transient Time in patient with idiopathic constipation
- Evaluating the effect of Colchicine on Colon Transient Time in patient with idiopathic constipation
- Evaluating the effect of Probiotics mixture on Colon Transient Time in patient with idiopathic constipation
* Design and method:
1-All patients who come to the Internal medicine clinic with complaints of constipation and have ROME III
2-Calculation of primary colonic transit time before getting the drug (5 capsules containing ten markers to calculate the transit time will be given to the patient, that eat within 24 hours and after 5 days Abdominal radiography of patients will be taken).
3- Colonoscopy patients with colonic transit time in the left or right colon, and exclusion the patients who normal colonic transit time or in the recto sigmoid part
4- Exclusion the patients who have secondary causes of constipation(Such as internal and external hemorrhoids, fissure, IBD, obstruction, polyps and tumors).
5- Divided 50 patients randomized to colchicine group and 50 patients in the prebiotic group
6- Calculation of Secondary colonic transit time after getting the drug (5 capsules containing ten markers to calculate the transit time will be given to the patient, that eat within 24 hours and after 5 days Abdominal radiography of patients will be taken).
* Participants include the Inclusion criteria and exclusion of participants:
Inclusion criteria: all patients who refer to the internal medicine clinic with complaints of constipation and have ROME III criteria.
Exclusion criteria: uncooperative patients to enter the study and evaluation of colonic transient time; patients who normal colonic transit time or in the recto sigmoid part; patients who have secondary causes of constipation; patients who don't complete treatment.
* Interventions:
- The first group get 0.6 mg of colchicine per day for 4 weeks
- The second group takes a 500mg probiotic capsule per day for 4 weeks.
* The main outcome variable:
Colon Transit Time
General information
Acronym
The effect of two drugs on Colon Transient Time
IRCT registration information
IRCT registration number:IRCT2014102119616N1
Registration date:2014-11-26, 1393/09/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-26, 1393/09/05
Registrant information
Name
Milad Rashidbeygi
Name of organization / entity
Student Research Committee, Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 1333 2142
Email address
miladrashidbeygi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized double blind clinical trial evaluating the effect of Colchicine & Probiotics mixture on Colon Transient Time in patient with idiopathic constipation
Public title
Evaluating the effect of Colchicine & Probiotics mixture on Colon Transient Time
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients who refer to the internal medicine clinic with complaints of constipation and have ROME III criteria.
Exclusion criteria: uncooperative patients to enter the study and evaluation of colonic transient time; patients who normal colonic transit time or in the recto sigmoid part; patients who have secondary causes of constipation; patients who don't complete treatment.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ilam University of Medical Sciences
Street address
Banajo street
City
Ilam
Postal code
6939177143
Approval date
2014-03-21, 1393/01/01
Ethics committee reference number
EC/93/H/240
Health conditions studied
1
Description of health condition studied
Idiopatic Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Colon transit time
Timepoint
Before and after treatment
Method of measurement
5 capsules containing ten markers
Secondary outcomes
empty
Intervention groups
1
Description
The first group get 0.6 mg of colchicine per day for 4 weeks
Category
Treatment - Drugs
2
Description
The second group takes a 500mg probiotic capsule per day for 4 weeks. Each capsule is composed of the following materials: 1- Lactobacillus casei 7 x 109 CFU/g; 2- Lactobacillus acidophilus 2 x109 CFU/g; 3- Lactobacillus rhamnosus 1.5 x109 CFU/g; 4- Lactobacillus bulgaricus 2 x 109CFU/g; 5-Bifidobacterium breve 2 x 109CFU/g; 6- Bifidobacterium longum 7 x 109CFU/g; 7- Streptococcus thermophilus 1.5 x 109 CFU/g.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private Clinic of Gastroenterology
Full name of responsible person
Mohammad Moradi
Street address
Sadie Street, Dr. Ghasemi Private Clinic of Gastroenterology
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Morovat Taheri Kalani
Street address
Banjo Street
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Student Committee Research, Ilam University of Medical Sciences
Full name of responsible person
Milad Rashidbeygi
Position
Medical Student
Other areas of specialty/work
Street address
Banajo Street
City
Ilam
Postal code
6931985481
Phone
+98 84 1223 5700
Fax
Email
miladrashidbeygi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical School,Ilam University of Medical Sciences
Full name of responsible person
Smaeil Ghasemi
Position
Pulmonary Specialty
Other areas of specialty/work
Street address
Banjo Street
City
Ilam
Postal code
Phone
+98 84 1223 5700
Fax
Email
smaeilghasemi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Student Research Committee, Ilam University of Medical Sciences
Full name of responsible person
Milad Rashidbeygi
Position
Medical Student
Other areas of specialty/work
Street address
Banajo Street
City
Ilam
Postal code
6931985481
Phone
+98 84 1223 5700
Fax
Email
miladrashidbeygi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)