It is a double blind, placebo controlled trial to assess the effect of exogenous lactase enzyme on reduction of lactose intolerance gastrointestinal symptoms in lactose intolerant patients. We studied 50 healthy symptomatic adults previously identified as being lactose intolerant by impaired h2 breath test. Each of subjects received lactase enzyme treatment for one week and placebo for equal time. The effectiveness of treatments was gathered by symptom evaluation questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902113740N1
Registration date:2010-05-21, 1389/02/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-21, 1389/02/31
Registrant information
Name
Behzad Asanjarani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 3031
Email address
asanjarani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2009-02-03, 1387/11/15
Expected recruitment end date
2009-09-06, 1388/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of exogenous lactase on reduction of lactose intolerance gastrointestinal symptoms in lactose intolerant patients compared with placebo
Public title
Assessment of exogenous lactase enzyme
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Positive lactose hydrogen breath test. Exclusion criteria: Incorrect use of lactase enzyme
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Allamolhoda St., Shahid Shiroodi Avenue
City
Arak
Postal code
3819693345
Approval date
2009-01-19, 1387/10/30
Ethics committee reference number
87-46-4
Health conditions studied
1
Description of health condition studied
Lactose intolerance
ICD-10 code
E73
ICD-10 code description
Lactose intolerance
Primary outcomes
1
Description
Treatment of lactose intolerance
Timepoint
One week after intervention
Method of measurement
Symptom evaluation questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
two oral capsuls each contained starch before milk and dairy for one week
Category
Placebo
2
Description
two oral capsuls each contained 3000 u lactase enzyme before milk and dairy for one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroentrology Clinic, Valiasr Hospital
Full name of responsible person
Dr Behzad Asanjarani
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ramin Ghahramani
Street address
Amiralmomenin Hospital
City
َArak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?