Effect of probiotic in intestinal bacterial overgrowth in the irritable bowel syndrome patients

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013122815959N1

Enrollment

172

Registered

2014-01-10

Start date

2013-02-01

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of Irritable bowel syndrome. Irritable bowel syndrome

Interventions

Intervention 1: Placebo made by Ahvaz Jondishapour Pharmacy University like probiotic capsule, ingestion one capsule per day for 3 months. Intervention 2: Mutaflor probiotic include 8/74-68/43 mg Ecol

Treatment - Drugs

Placebo made by Ahvaz Jondishapour Pharmacy University like probiotic capsule, ingestion one capsule per day for 3 months

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

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Incidence of adverse effects of probiotic. Timepoint: At the end of third month of treatment. Method of measurement: Asking from patients.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahinzadeh Sam

Ahvaz Jondishapour University of Medical Sciences

samsorena@yahoo.com+98 61 1222 0168

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026