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Comparison of probiotic effect with placebo in prevention of recurrence of intestinal bacterial overgrowth in the irritable bowel syndrome patients

Protocol summary

Summary
Objective: comparison of probiotics effect with placebo in prevention of recurrence of small intestinal bacterial overgrowth in patients with irritable bowel syndrome. One hundred seventy two patients with irritable bowel syndrome based on ROME III criteria and small intestinal bacterial overgrowth based on positive breath test referred to gastroenterology clinic were assessed. These patients were enrolled in study after exclusion of important gastrointestinal diseases based on history, physical exam and lab tests and they were excluded if they had sensitivity to antibiotics, pregnancy, lactation, previous abdominal surgery, past medical history of hypothyroidism, malignancies, renal and liver insufficiency, diabetes, familial history of colorectal carcinoma, ingestion of immunosuppressives and antibiotics in recent 2 months and ingestion of probiotics for more than 2 weeks in recent 6 months. These patients received a 10 days period of antibiotics initially and then after a negative breath test they were divided into 2 groups (probiotic and placebo) randomly based on random number tables. One group received mutaflor probiotic included of 8/74-68/43 mg EColi nissle 1917 strain made by Ardeypharm Gmbh company in Germany, one capsule per day and the other group received placebo made by Ahvaz Jondishapour Pharmacy University similar to probiotic, one capsule per day for 3 months. After 3 months treatment with probiotic or placebo, recurrence of small intestinal bacterial overgrowth was assessed by repetition of hydrogen breath test and was compared between 2 groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013122815959N1
Registration date: 2014-01-10, 1392/10/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-01-10, 1392/10/20
Registrant information
Name
Sam Shahinzadeh
Name of organization / entity
Ahvaz Jondishapour University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 622 1620
Email address
shahinzadeh.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Ahvaz Jondishapour University of Medical Science
Expected recruitment start date
2013-02-01, 1391/11/13
Expected recruitment end date
2013-07-30, 1392/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison of probiotic effect with placebo in prevention of recurrence of intestinal bacterial overgrowth in the irritable bowel syndrome patients
Public title
Effect of probiotic in intestinal bacterial overgrowth in the irritable bowel syndrome patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with irritable bowel syndrome based on ROME III criteria and small intestinal bacterial overgrowth based on positive hydrogen breath test. Exclusion criteria: patients with sensitivity to antibiotics, pregnancy, lactation, previous abdominal surgery, past medical history of hypothyroidism, celiac, malignancy, renal and liver insufficiency, diabetes and inflammatory bowel disease, familial history of colorectal carcinoma, ingestion of immunosuppressives and antibiotics in recent 2 months, ingestion of probiotics for more than 2 weeks in recent 6 months.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 172
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondishapour University of Medical Sciences
Street address
Golestan boulevard, Jondishapour University Center
City
Ahvaz
Postal code
Approval date
2013-12-04, 1392/09/13
Ethics committee reference number
ajums.REC.1392.181

Health conditions studied

1

Description of health condition studied
Treatment of Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome

Primary outcomes

1

Description
Expiratory hydrogene
Timepoint
After 10 days treatment with antibiotics and after 3 months treatment with probiotic
Method of measurement
Expiratory hydrogene with micro H2 and hydar hydrogene breath test after ingestion of 1 gram per kilogram body weight glucose in 150 ml water based on ppm

Secondary outcomes

1

Description
Incidence of adverse effects of probiotic
Timepoint
At the end of third month of treatment
Method of measurement
Asking from patients

Intervention groups

1

Description
Placebo made by Ahvaz Jondishapour Pharmacy University like probiotic capsule, ingestion one capsule per day for 3 months
Category
Treatment - Drugs

2

Description
Mutaflor probiotic include 8/74-68/43 mg Ecoli Nissle 1917 strain made by Ardeypharm Gmbh Company in Germany, ingestion of one capsule per day for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology clinic of Ahvaz Imam Khomeini Hospital
Full name of responsible person
Jadbabaie Maryam
Street address
20 meters Street, Imam Khomeini Hospital
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Feghi Mostafa
Street address
Golestan Boulevard, University center, Vice chancellor for research
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Ahvaz Jondishapour 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
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Shahinzadeh Sam
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
20 meters street, Imam Khomeini Hospital, Internal medicine department
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
samsorena@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Shahinzadeh Sam
Position
Internal Medicine resident
Other areas of specialty/work
Street address
20 meters street, Imam Khomeini Hospital, Internal medicine department
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
samsorena@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Shahinzadeh Sam
Position
Internal medicine resident
Other areas of specialty/work
Street address
20 meters street, Imam Khomeini Hospital, Internal medicine department
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
samsorena@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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