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Efficacy and Safety of Saccharomyces Boulardii in the Treatment of Small Intestinal Bacterial Overgrowth

NCT ID: NCT04627337

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-08-31

Brief Summary

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Non-constipated irritable bowel syndrome is a common disorder that may be related to small intestinal bacterial overgrowth. Saccharomyces boulardii CNCM I-745 is a probiotic yeast that has proven efficacy for the treatment of acute gastroenteritis and antibiotic-associated diarrhea. However, its efficacy for the treatment of diarrhea-predominant irritable bowel syndrome with small intestinal bacterial overgrowth has not been assessed. Hence, an exploratory randomized, open label trial comparing the efficacy and safety of Saccharomyes boulardii CNCM I-745 plus diet administration versus diet administration only for 15 days among adult patients with the aforementioned condition was conducted.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Saccharomyces boulardii (1 capsule of 250 ug BID) + Dietary advice

Patients received 1 capsule of Saccharomyces boulardii 250 ug BID plus dietary advice for 15 days. Dietary advice consisted of a low fermentation diet which was delivered as a written list of food and beverages that patients should avoid adapted to local habits and an oral explanation by a health professional.

Group Type EXPERIMENTAL

Saccharomyces Boulardii 250 MG

Intervention Type DRUG

Probiotic yeast in capsules

Dietary advice following a low fermentation diet

Intervention Type BEHAVIORAL

Medical advice was delivered to patients to follow a low fermentation diet. A list of food and beverages to avoid was delivered along with specified instructions provided by a health professional

Dietary advice without medication

Patients received dietary advice for 15 days. Dietary advice consisted of a low fermentation diet which was delivered as a written list of food and beverages that patients should avoid adapted to local habits and an oral explanation by a health professional.

Group Type ACTIVE_COMPARATOR

Dietary advice following a low fermentation diet

Intervention Type BEHAVIORAL

Medical advice was delivered to patients to follow a low fermentation diet. A list of food and beverages to avoid was delivered along with specified instructions provided by a health professional

Interventions

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Saccharomyces Boulardii 250 MG

Probiotic yeast in capsules

Intervention Type DRUG

Dietary advice following a low fermentation diet

Medical advice was delivered to patients to follow a low fermentation diet. A list of food and beverages to avoid was delivered along with specified instructions provided by a health professional

Intervention Type BEHAVIORAL

Other Intervention Names

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Dietary advice following a low fermentation diet

Eligibility Criteria

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Inclusion Criteria

* Adult patients
* Diagnosis of Irritable Bowel syndrome according to Rome III criteria
* Diagnosis of concomitant small intestinal bacterial overgorwth (SIBO) by breath test

Exclusion Criteria

* Pregnancy
* Diagnosis of Celiac disease
* Diagnosis of Inflammatory Bowel Disease or other immune-mediated gastrointestinal conditions
* Immunosuppression
* Diagnosis of active cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

OTHER

Sponsor Role lead

Responsible Party

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Juan Lasa

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CEMIC

Buenos Aires, , Argentina

Site Status

Countries

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Argentina

Other Identifiers

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CEIBO01

Identifier Type: -

Identifier Source: org_study_id