Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02204891 |
Date of registration:
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28/07/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Probiotics in Intestinal Bacterial Overgrowth
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Scientific title:
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A Clinical Study of the Efficacy of a Formulation of Four Probiotics in Patients With Syndrome of Intestinal Bacterial Overgrowth and Irritable Bowel Syndrome |
Date of first enrolment:
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September 2014 |
Target sample size:
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26 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02204891 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Evangelos Giamarellos-Bourboulis, MD, PhD |
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Telephone:
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Email:
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Affiliation:
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University of Athens, Medical School |
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Name:
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Konstantinos Triantafyllou, MD, PhD |
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Telephone:
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Email:
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Affiliation:
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University of Athens, Medical School |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age =18 years
2. Both genders
3. Written informed consent by study participants
4. Presence of IBS according to Rome III criteria
5. Equal number of SIBO-positive and SIBO-negative patients
Exclusion Criteria:
1. Age <18 years
2. Deny to consent
3. Pregnancy or lactation
4. Presence of inflammatory bowel disease
5. Presence of acute GI tract infection
6. Diabetes mellitus type 1 or type 2
7. Use of laxatives and antibiotics within the preceding 6 weeks
8. Presence of fever, abdominal mass, signs of bowel obstruction and/or leucocytosis
9. Abnormal serum levels of thyroid -stimulating hormone.
10. History of colon cancer or diverticulitis
11. Infection by human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C
virus
12. Patients with celiac disease defined by biopsy of the duodenal mucosa.
13. History of scleroderma and gastroparesis
14. Pregnancy or planning pregnancy the next 3 months
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Irritable Bowel Syndrome
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Intervention(s)
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Dietary Supplement: Probiotics in SIBO
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Dietary Supplement: Probiotics
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Primary Outcome(s)
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• The efficacy of probiotics in improvement of symptoms of IBS in patients with SIBO compared to their efficacy in patients with IBS without SIBO.
[Time Frame: 30 days]
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Secondary Outcome(s)
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• The importance of the inflammation cascade in the pathogenesis of SIBO-related IBS.
[Time Frame: 30 days]
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• The efficacy of probiotics in symptoms of IBS in patients with SIBO compared to their efficacy in patients with IBS without SIBO.
[Time Frame: 60 days]
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The efficacy of probiotics in specific symptoms of IBS both visits 2 and 3.
[Time Frame: Days 30 and 60]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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