Therapeutic effects of low-dose Bismuth subcitrate on symptoms and health-related quality of life in adult patients with irritable bowel syndrome: A clinical trial
Irritable bowel syndrome (IBS) is a chronic functional disorder of the gastrointestinal tract that causes abdominal pain or discomfort, and altered bowel with no organic abnormalities.This article is a placebo controlled clinical trial to assess the therapeutic effects of low dose bismuth subcitrate on symptoms and the health-related quality of life in adult patients with IBS.This clinical trial was done in Isfahan,Iran.For each of three subtypes (IBS-C,IBS-D, and IBS-M) we included patients with IBS , diagnosed according to Rome III criteria.They were allocated to placebo (group A) and intervention (group B) consecutively (one to the intervention and one patient to the placebo group)by a non-therapist member of research team.The medication for group B was mebeverine and bismuth subcitrate and for group A was mebeverine and placebo of bismuth subcitrate.With respect to quality of life, the trend of IBS-QOL Score changed significantly during the study period in both intervention and placebo groups .The trends of changes in the severity of pain and bloating during the study among the intervention and control group was significantly different.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081435691N1
Registration date:2017-09-07, 1396/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-07, 1396/06/16
Registrant information
Name
Hamed Daghaghzadeh
Name of organization / entity
Isfahan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 3880
Email address
daghaghzade@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-06-21, 1394/03/31
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of low-dose Bismuth subcitrate on symptoms and health-related quality of life in adult patients with irritable bowel syndrome: A clinical trial
Public title
Therapeutic effects of low-dose Bismuth subcitrate on symptoms and health-related quality of life in adult patients with irritable bowel syndrome: A clinica ltrial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis irritable bowel syndrome based on Rome 3 criteria; age>18 ; both sex. Exclusion criteria:age<18 and age>70 ; pregnancy; having a documented chronic heart or liver failure; surgery on the gastrointestinal tract except appendectomy; malabsorption diseases; hyperthyroidism; inflammatory bowel diseases; connective tissue diseases; severely progressive diseases, diabetes mellitus; use of antibiotic drugs within a month before the study; significant weight loss; fever; and bloody stools.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Regional Bioethics Committee
Street address
Isfahan University of Medical Sciences
City
isfahan
Postal code
Approval date
2015-08-01, 1394/05/10
Ethics committee reference number
IR.MUI.REC.1392.2.076
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
k58
ICD-10 code description
irritable colon
2
Description of health condition studied
Irritable bowel syndrome with diarrhea
ICD-10 code
k58.0
ICD-10 code description
Irritable bowel syndrome with diarrhea
3
Description of health condition studied
Irritable bowel syndrome without diarrhea
ICD-10 code
k58.9
ICD-10 code description
Irritable bowel syndrome without diarrhea
Primary outcomes
1
Description
Quality of life
Timepoint
4 month wth monthly follow up
Method of measurement
IBS-qol questionare
2
Description
Bloating
Timepoint
4 month wth monthly follow up
Method of measurement
questionare
3
Description
Abdominal pain
Timepoint
4 month wth monthly follow up
Method of measurement
Questionare
4
Description
Satisfaction of defication
Timepoint
4 month wth monthly follow up
Method of measurement
Questionare
5
Description
Ibs duration
Timepoint
4 month wth monthly follow up
Method of measurement
questionare
6
Description
Age
Timepoint
4 month wth monthly follow up
Method of measurement
Questionare
7
Description
Sex
Timepoint
4 month wth monthly follow up
Method of measurement
Questionare
Secondary outcomes
empty
Intervention groups
1
Description
The pharmacotherapy regimen for the intervention group was mebeverine hydrochloride 200 mg capsule once daily ( before breakfast ) and bismuth subcitrate 120 mg tablet twice daily (30 min before breakfast and dinner).
Category
Treatment - Drugs
2
Description
For the placebo group,mebeverine hydrochloride 200mg capsule once daily(before breakfast) and placebo of bismuth subcitrate(that did not have any effective material) 120 mg tablet twice daily(30 min breakfast and dinner meal)was were given
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Hamed Daghaghzadeh private clinic
Full name of responsible person
Dr.Hamed Daghaghzadeh
Street address
Dr.Hamed daghaghzadeh private clinic, shams abadi St , Isfahan