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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

Tracking Information
First Submitted Date  ICMJE July 28, 2014
First Posted Date  ICMJE July 31, 2014
Last Update Posted Date March 20, 2017
Actual Study Start Date  ICMJE September 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2014)
• 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02204891 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2014)
  • • 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.
  • 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.
  • • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotics in Intestinal Bacterial Overgrowth
Official Title  ICMJE A Clinical Study of the Efficacy of a Formulation of Four Probiotics in Patients With Syndrome of Intestinal Bacterial Overgrowth and Irritable Bowel Syndrome
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • 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
  • Dietary Supplement: Probiotics
    One capsule twice daily for 30 days
Study Arms  ICMJE
  • Experimental: Probiotics in SIBO
    Administration of probiotics in patients with IBS and SIBO
    Intervention: Dietary Supplement: Probiotics in SIBO
  • Active Comparator: Probiotics
    Administration of probiotics in patients with IBS without SIBO
    Intervention: Dietary Supplement: Probiotics
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2017)
26
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2014)
60
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02204891
Other Study ID Numbers  ICMJE LACTO01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens
Study Sponsor  ICMJE University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Konstantinos Triantafyllou, MD, PhD University of Athens, Medical School
Principal Investigator: Evangelos Giamarellos-Bourboulis, MD, PhD University of Athens, Medical School
PRS Account University of Athens
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP