The Small Intestine Bacterial Overgrowth Study Pilot
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Small Intestinal Bacterial Overgrowth
- Systemic Sclerosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The primary objective of this randomized trial is to determine if a structured, treat-to-target algorithm based on treatment response and relapse performs better than standard care for the treatment of symptoms SSc-SIBO.Masking: Single (Investigator)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Objectives: To determine the feasibility of the full project. This will be a trial with 3 months of recruitment and 6 months of follow up for each case. Specific Aims: Determine if REBs perceive any major issues regarding the full trial. Determine if the sites are consenting all eligible patients. D...
Objectives: To determine the feasibility of the full project. This will be a trial with 3 months of recruitment and 6 months of follow up for each case. Specific Aims: Determine if REBs perceive any major issues regarding the full trial. Determine if the sites are consenting all eligible patients. Determine the signing rate of consent. Determine patient adherence to web access for questionnaires. Assess the method for detecting eligible cases from web questionnaires. Assess whether physician notifications are being sent out quickly after detecting eligible cases. Assess the timeliness and completeness of physician receipt of notification of patient eligibility. Assess physician adherence to treatment protocol: how soon protocol patients are brought in to see doctor after receipt of notice. does doctor record what he does accurately. does he/she schedule return visits according to protocol. does he/she use in office questionnaires for treat to target. does he/she base decisions on these questionnaires. does he/she follow algorithm sequentially. For control sites, Record how soon protocol patients are brought in to see doctor after receipt of notice. Assess whether the doctor accurately records what he/she does. 10 international sites will be chosen from the INSYNC cohort located in Australia, Canada, the U.S., the Netherlands, Spain, Germany and Sweden. In each country one site will be randomly selected to be a protocol site and one standard care site. This selection will provide representation from English and non-English speaking centres and from an array of countries with different medical cultures.
Tracking Information
- NCT #
- NCT03588845
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Not Provided
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