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Effectiveness of Saccharomyces Boulardii for Gastrointestinal Bacterial-overgrowth in Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT03692299
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Maria del Pilar Cruz Dominguez, Coordinación de Investigación en Salud, Mexico

Brief Summary:

Introduction. Autonomic dysfunction, smooth muscle fibrosis and vascular damage lead to small intestinal bacterial overgrowth (SIBO) in Systemic Sclerosis (SSc). SIBO is characterized by diarrhea, abdominal pain, bloating, malabsorption and malnutrition.

Aim. To evaluate the efficacy and safety of Saccharomyces boulardii in combination with metronidazole for 2 months for reducing gastrointestinal symptoms (NIH-PROMIS) and preventing bacterial overgrowth (hydrogen breath test) versus the standard treatment in patients with systemic sclerosis.

Method. Controlled clinical trial conduct in patients with SSc (ACR-EULAR 2015) who signed informed consent. NIH PROMIS®questionarie will be apply to evaluate gastrointestinal symptoms and classify in not symptomatic, least, mildy, moderately and most symptomatic. Glucose HBT will be apply after 14 hours fast, oral hygiene and 30 days free of antibiotics to evaluate SIBO. Patients with negative HBT and symptoms associated to glucose ingestion will repeat test with lactulose. Patients will be aleatorized into (1) Saccharomyces boulardii, (2) Metronidazole and (3) Metronidazole plus Saccharomyces boulardii.

All data will be analyzed using SPSS software. It will be used parametric statistics for normally distributed variables and nonparametric statistics for free distribution.


Condition or disease Intervention/treatment Phase
Systemic Sclerosis Small Intestinal Bacterial Overgrowth Drug: Saccharomyces Boulardii Oral Tablet Drug: Metronidazole Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efectividad de Saccharomyces Oulardii Para Reducir Los síntomas Gastrointestinales y Evitar el Sobrecrecimiento Bacteriano en Esclerosis sistémica
Study Start Date : June 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Active Comparator: Saccaromyces boulardii oral tablet
Saccharomyces boulardii Oral Tablet 200 mg b.i.d. during 2 weeks, followed by a 2-week rest period and then again 200 mg b.i.d. during 2 consecutive months.
Drug: Saccharomyces Boulardii Oral Tablet
Saccharomyces boulardii 200 mg b.i.d. during 2 weeks, followed by a 2-week rest period and then again 200 mg b.i.d. during 2 consecutive months.
Other Name: Saccaromyces boulardii

Active Comparator: Metronidazole plus S. boulardii
Metronidazole 500 mg b.i.d during 1 week, followed by a 3-week rest period and then again 500 mg b.i.d during 2 consecutive months.
Drug: Saccharomyces Boulardii Oral Tablet
Saccharomyces boulardii 200 mg b.i.d. during 2 weeks, followed by a 2-week rest period and then again 200 mg b.i.d. during 2 consecutive months.
Other Name: Saccaromyces boulardii

Drug: Metronidazole
Metronidazole 500 mg b.i.d during 1 week, followed by a 3-week rest period and then again 500 mg b.i.d during 2 consecutive months
Other Name: Metronidazole alone

Active Comparator: Metronidazole
Metronidazole 500 mg b.i.d during 1 week, plus Saccharomyces boulardii 200 mg b.i.d. during 1 week, follow for only Saccharomyces 200 mg b.i.d. for one another week, 2-week rest period and then this regimen is repeated for two consecutive months.
Drug: Metronidazole
Metronidazole 500 mg b.i.d during 1 week, followed by a 3-week rest period and then again 500 mg b.i.d during 2 consecutive months
Other Name: Metronidazole alone




Primary Outcome Measures :
  1. Small intestinal Bacterial Overgrowth (Presence or absence) [ Time Frame: baseline, second month ]
    Small intestinal Bacterial Overgrowth will be measured by a breath test using a hydrogen monitor. Hydrogen is part of the bacteria metabolism and can be detected in breath. it can be quantified in parts per million. We wil consider presence of Small intestinal Bacterial Overgrowth if a measure > 10 part per million is obtained in our patients. We will compare the presence or abscense of Small intestinal bacterial overgrowth after the intervention.


Secondary Outcome Measures :
  1. Intensity of gastrointestinal symptoms [ Time Frame: baseline, second month ]
    The patients that will be included in our protocol are characterized by having important gastrointestinal symptoms, inherent to its disease. The NIH Patient-Reported Outcomes Measurement Information System (NIH-PROMIS) is a tool used to assess gastrointestinal symptoms. It consist on a 48 items survey that can be answered in less than 15 minutes. A percentile is obtained after collecting data from each survey, and accordingly, we can classify the intensity of gastrointestinal symptoms.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Social security beneficiaries affiliated to the "LA RAZA" UMAE HECMN
  • Adults over 18 years old
  • Male or female subjects
  • Diagnosed with scleroderma (2013 ACR-EULAR)
  • Score above the 25th percentile in NIH-PROMIS questionnaire
  • Positive result (> 10 ppm) in the hydrogen breath test
  • Normal leukocyte and lymphocyte profiles
  • Patients who accept to participate in the study by signing the informed consent form

Exclusion Criteria:

  • Gastrointestinal diseases already diagnosed and not associated to systemic sclerosis
  • Comorbidities associated to visceral diseases (diabetes, amyloidosis or other infiltrative diseases)
  • Currently under biological treatment (or history of biological treatment in the last year) with cyclophosphamide and > 10 mg prednisone or equivalent
  • Allergy or contra-indications to metronidazole or to Saccharomyces boulardii,
  • Central venous catheter carriers

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): NCT03692299


Contacts
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Contact: María Pilar Cruz-Domínguez, PhD 57245900 ext 23008 drapilarcd@live.com.mx

Locations
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Mexico
Maria del Pilar Cruz Dominguez Recruiting
Mexico, Mexico City, Mexico, 07800
Contact: Maria del Pilar Cruz-Dominguez, MD    5557245900 ext 23015    maria.cruzdo@live.com.mx   
Sub-Investigator: Grettel García Collinot, MD         
Sub-Investigator: Pablo Ramírez Mendoza, MD         
Sub-Investigator: Margarita Martínez Cruz, Nutrition         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
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Principal Investigator: Maria Pilar Cruz-Domínguez, PhD Instituto Mexicano del Seguro Social

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Responsible Party: Maria del Pilar Cruz Dominguez, Chief of Researh Division, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT03692299     History of Changes
Other Study ID Numbers: R-2015-3501-72
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maria del Pilar Cruz Dominguez, Coordinación de Investigación en Salud, Mexico:
Systemic Sclerosis
Small Intestinal Bacterial Overgrowth
Saccaromyces boulardii

Additional relevant MeSH terms:
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Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents