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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03692299 |
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Date of registration:
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20/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of Saccharomyces Boulardii for Gastrointestinal Bacterial-overgrowth in Systemic Sclerosis
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Scientific title:
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Efectividad de Saccharomyces Oulardii Para Reducir Los síntomas Gastrointestinales y Evitar el Sobrecrecimiento Bacteriano en Esclerosis sistémica |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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39 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03692299 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Maria Pilar Cruz-Domínguez, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Mexicano del Seguro Social |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Small Intestinal Bacterial Overgrowth
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Systemic Sclerosis
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Intervention(s)
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Drug: Metronidazole
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Drug: Saccharomyces Boulardii Oral Tablet
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Primary Outcome(s)
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Small intestinal Bacterial Overgrowth (Presence or absence)
[Time Frame: baseline, second month]
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Secondary Outcome(s)
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Intensity of gastrointestinal symptoms
[Time Frame: baseline, second month]
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Secondary ID(s)
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R-2015-3501-72
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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