NCT02204891

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

July 28, 2014

Last Update Submit

March 17, 2017

Conditions

Irritable Bowel Syndrome

Keywords

Abdominal painAbdominal discomfortFlatulenceDiarrheaBacterial overgrowthCytokines

Outcome Measures

Primary Outcomes (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.

    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.

    30 days

Secondary Outcomes (3)

  • • The efficacy of probiotics in symptoms of IBS in patients with SIBO compared to their efficacy in patients with IBS without SIBO.

    60 days

  • The efficacy of probiotics in specific symptoms of IBS both visits 2 and 3.

    Days 30 and 60

  • • The importance of the inflammation cascade in the pathogenesis of SIBO-related IBS.

    30 days

Study Arms (2)

Probiotics in SIBO

EXPERIMENTAL

Administration of probiotics in patients with IBS and SIBO

Dietary Supplement: Probiotics in SIBO

Probiotics

ACTIVE COMPARATOR

Administration of probiotics in patients with IBS without SIBO

Dietary Supplement: Probiotics

Interventions

Probiotics in SIBODIETARY_SUPPLEMENT

Mixture of the four probiotics in one capsule. One capsule twice daily for 30 days

Also known as: Saccharomyces Bifidobacterium Lactobacillus species
Probiotics in SIBO
ProbioticsDIETARY_SUPPLEMENT

One capsule twice daily for 30 days

Probiotics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Both genders
  • Written informed consent by study participants
  • Presence of IBS according to Rome III criteria
  • Equal number of SIBO-positive and SIBO-negative patients

You may not qualify if:

  • Age \<18 years
  • Deny to consent
  • Pregnancy or lactation
  • Presence of inflammatory bowel disease
  • Presence of acute GI tract infection
  • Diabetes mellitus type 1 or type 2
  • Use of laxatives and antibiotics within the preceding 6 weeks
  • Presence of fever, abdominal mass, signs of bowel obstruction and/or leucocytosis
  • Abnormal serum levels of thyroid -stimulating hormone.
  • History of colon cancer or diverticulitis
  • Infection by human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus
  • Patients with celiac disease defined by biopsy of the duodenal mucosa.
  • History of scleroderma and gastroparesis
  • Pregnancy or planning pregnancy the next 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, ATTIKON University Hospital

Athens, Attica, 12462, Greece

Location

Related Publications (6)

  • Pyleris E, Giamarellos-Bourboulis EJ, Tzivras D, Koussoulas V, Barbatzas C, Pimentel M. The prevalence of overgrowth by aerobic bacteria in the small intestine by small bowel culture: relationship with irritable bowel syndrome. Dig Dis Sci. 2012 May;57(5):1321-9. doi: 10.1007/s10620-012-2033-7. Epub 2012 Jan 20.

    PMID: 22262197BACKGROUND

  • Choi CH, Jo SY, Park HJ, Chang SK, Byeon JS, Myung SJ. A randomized, double-blind, placebo-controlled multicenter trial of saccharomyces boulardii in irritable bowel syndrome: effect on quality of life. J Clin Gastroenterol. 2011 Sep;45(8):679-83. doi: 10.1097/MCG.0b013e318204593e.

    PMID: 21301358BACKGROUND

  • Ringel-Kulka T, Palsson OS, Maier D, Carroll I, Galanko JA, Leyer G, Ringel Y. Probiotic bacteria Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 versus placebo for the symptoms of bloating in patients with functional bowel disorders: a double-blind study. J Clin Gastroenterol. 2011 Jul;45(6):518-25. doi: 10.1097/MCG.0b013e31820ca4d6.

    PMID: 21436726BACKGROUND

  • Ki Cha B, Mun Jung S, Hwan Choi C, Song ID, Woong Lee H, Joon Kim H, Hyuk J, Kyung Chang S, Kim K, Chung WS, Seo JG. The effect of a multispecies probiotic mixture on the symptoms and fecal microbiota in diarrhea-dominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Gastroenterol. 2012 Mar;46(3):220-7. doi: 10.1097/MCG.0b013e31823712b1.

    PMID: 22157240BACKGROUND

  • Yoon JS, Sohn W, Lee OY, Lee SP, Lee KN, Jun DW, Lee HL, Yoon BC, Choi HS, Chung WS, Seo JG. Effect of multispecies probiotics on irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Gastroenterol Hepatol. 2014 Jan;29(1):52-9. doi: 10.1111/jgh.12322.

    PMID: 23829297BACKGROUND

  • Leventogiannis K, Gkolfakis P, Spithakis G, Tsatali A, Pistiki A, Sioulas A, Giamarellos-Bourboulis EJ, Triantafyllou K. Effect of a Preparation of Four Probiotics on Symptoms of Patients with Irritable Bowel Syndrome: Association with Intestinal Bacterial Overgrowth. Probiotics Antimicrob Proteins. 2019 Jun;11(2):627-634. doi: 10.1007/s12602-018-9401-3.

    PMID: 29508268DERIVED

MeSH Terms

Conditions

Irritable Bowel SyndromeAbdominal PainFlatulenceDiarrhea

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Konstantinos Triantafyllou, MD, PhD

    University of Athens, Medical School

    PRINCIPAL INVESTIGATOR

  • Evangelos Giamarellos-Bourboulis, MD, PhD

    University of Athens, Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 31, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

March 20, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)