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Probiotics in Intestinal Bacterial Overgrowth

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ClinicalTrials.gov Identifier: NCT02204891
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens

Brief Summary:
The aim of the present study is to demonstrate the effect of a mixture of four species of probiotics (Saccharomyces boulardii, Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5 and Lactobacillus plantarum) in patients with symptomatic irritable bowel syndrome (IBS) who have culture verified syndrome of intestinal bacterial overgrowth (SIBO) and those who do not have. This will provide direct evidence for the role of probiotics in treating part of the pathogenesis of IBS.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Probiotics in SIBO Dietary Supplement: Probiotics Not Applicable

Detailed Description:

Irritable bowel syndrome (IBS) is the most common gastrointestinal disorder. Pathogenesis remains multifactorial. Better understanding of the interaction of the host with intestinal microbiota the last decade led to the knowledge that many of the symptoms of IBS, mainly bloating and diarrhea, are related with the overgrowth of bacteria of colonic type in the small intestine. This overgrowth frames the syndrome of intestinal bacterial overgrowth (SIBO) where colonic type of bacteria predominate in the proximal parts of the small intestine. Fermentation of dietary carbohydrates by the bacteria colonizers of SIBO ends with the over-production of gas generating thus symptoms of IBS. The relationship between IBS and SIBO was found by a series of prospective observational studies using the lactulose and the glucose tolerance tests for the diagnosis of SIBO. Using this test, the prevalence of SIBO in patients with IBS ranged between 65 and 85%. The gold-standard technique for the diagnosis of SIBO is the quantitative culture of the content of the proximal intestine i.e. of the duodenum after upper GI tract endoscopy. Few studies are available with this design and they suggest a growth of colonic type of flora at counts equal to or greater than 10^5 cfu/ml as diagnostic of SIBO. Based on systematic review of the literature but also on data generated in a cohort of 320 consecutive patients undergoing upper GI tract endoscopy, normal subjects are never greater than 10^3 cfu/m in the duodenum. In the latter publication coming from Athens, using variable cut-offs greater than 10^3 or 10^4 or 10^5 cfu/ml for the diagnosis of SIBO, the frequency of SIBO was significantly greater among sufferers than among non-sufferers from IBS.

Oral supplementation with probiotics may be a rational approach for the eradication of SIBO and subsequently of the symptoms of IBS. The majority of probiotic bacteria belong to the Lactobacillus and Bifidobacterium genera. They are Gram-positive lactic acid-producing bacteria that constitute a major part of the normal intestinal microflora in animals and humans. The rationale behind their use as a therapeutic strategy in IBS is that orally administered probiotics may replace the overgrown enteric-type bacteria of SIBO. Four randomized clinical trials are available evaluating the efficacy of orally administered probiotics in IBS. The common findings of these trials are that a) efficacy refers to the improvement of symptoms of bloating and of diarrhea that are typical symptoms of the presence of SIBO; and b) efficacy is usually found when mixtures of different species of probiotics are used. However, no study has ever tested the efficacy of probiotics in patients with IBS and SIBO proven by small intestinal culture.

The aim of the present study is to demonstrate the effect of a mixture of four species of probiotics (Saccharomyces boulardii, Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5 and Lactobacillus plantarum) in patients with symptomatic IBS who have culture verified SIBO and those who do not have. This will provide direct evidence for the role of probiotics in treating part of the pathogenesis of IBS.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Probiotics in SIBO
Administration of probiotics in patients with IBS and SIBO
Dietary Supplement: Probiotics in SIBO
Mixture of the four probiotics in one capsule. One capsule twice daily for 30 days
Other Name: Saccharomyces Bifidobacterium Lactobacillus species

Active Comparator: Probiotics
Administration of probiotics in patients with IBS without SIBO
Dietary Supplement: Probiotics
One capsule twice daily for 30 days




Primary Outcome Measures :
  1. • 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 ]
    This will be assessed after 30 days from start of therapy (visit 2) by comparisons of grading of symptoms and results of OLT between the two groups of treatment.


Secondary Outcome Measures :
  1. • 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 ]
    This will be assessed after 60 days from start of therapy (visit 3) by comparisons of grading of symptoms and results of OLT between the two groups of treatment.

  2. The efficacy of probiotics in specific symptoms of IBS both visits 2 and 3. [ Time Frame: Days 30 and 60 ]
    This will be done by comparing the grading for every symptom of IBS of patients in visits 2 and 3 compared with the baseline visit 1.

  3. • The importance of the inflammation cascade in the pathogenesis of SIBO-related IBS. [ Time Frame: 30 days ]
    This will be done by comparing the duodenal aspirate cytokines of the two groups of treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204891


Locations
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Greece
Department of Gastroenterology, ATTIKON University Hospital
Athens, Attiki, Greece, 12462
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Konstantinos Triantafyllou, MD, PhD University of Athens, Medical School
Principal Investigator: Evangelos Giamarellos-Bourboulis, MD, PhD University of Athens, Medical School

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Evangelos J. Giamarellos-Bourboulis, M.D., Associate Professor of Medicine, University of Athens
ClinicalTrials.gov Identifier: NCT02204891     History of Changes
Other Study ID Numbers: LACTO01
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens:
Abdominal pain
Abdominal discomfort
Flatulence
Diarrhea
Bacterial overgrowth
Cytokines
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases