Probiotics in Intestinal Bacterial Overgrowth

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02204891
• Date of registration: 28/07/2014
• Prospective Registration: Yes
• Primary sponsor: University of Athens
• Public title: Probiotics in Intestinal Bacterial Overgrowth
• Scientific title: 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: September 2014
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02204891
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Greece

Contacts

• Name: Evangelos Giamarellos-Bourboulis, MD, PhD
• Affiliation: University of Athens, Medical School

• Name: Konstantinos Triantafyllou, MD, PhD
• Affiliation: University of Athens, Medical School

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome

Intervention(s)

Dietary Supplement: Probiotics

Dietary Supplement: Probiotics in SIBO

Primary Outcome(s)

• 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]

Secondary Outcome(s)

• 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]

The efficacy of probiotics in specific symptoms of IBS both visits 2 and 3. [Time Frame: Days 30 and 60]

• The importance of the inflammation cascade in the pathogenesis of SIBO-related IBS. [Time Frame: 30 days]

Secondary ID(s)

LACTO01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors