An interventional study of Treatment Protocol and Standard of Care in Systemic Sclerosis and Small Intestinal Bacterial Overgrowth, sponsored by Canadian Scleroderma Research Group. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-17.
Sponsored by Canadian Scleroderma Research Group · Not applicable, Interventional, and Diagnostic
This is a pragmatic study in which will compare a detailed treat-to-target (T2T) treatment algorithm to standard care for SSc SIBO at multiple sites around the world. The treatment algorithm was developed from the results of a survey of SIBO treatment preferences of rheumatologists and gastroenterologists. Although the drugs in the algorithm are already used in SSc, there is no uniform way of doing this and assessing the patient response. A very standardized protocol was created with details of how to use the medications, the duration of use and the timing of different drugs. In addition, symptoms of SIBO will be dectected by having patients complete a validated screening questionnaire, the global symptomatic score (GSS), online every 3 months for the duration of the study. A score > 5 is very strongly related to bacterial overgrowth. In other studies, about 40% of unselected patients score at this level. This same questionnaire will be used in the T2T doctors' offices to decide if response is adequate and will also be used to assess outcome in the algorithm group versus standard care group.
The primary outcome is the change in symptoms based on the total GSS. Secondary outcomes will include examination of all GSS subscales. HRQoL will be assessed by the social scale of the newly developed UCLA SSc GIT 2.0 questionnaire, which has become the standard GI questionnaire in SSc trials.
RN. # 00296313
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:
Assess physician adherence to treatment protocol:
For control sites,
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.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's planned enrollment of 500 is above the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →This is the only study on the registry with Canadian Scleroderma Research Group as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
If a score on the GSS is \> 5, the computer will send an automatic notice to the office of the doctor and to the doctor him/herself telling them of this. Upon receipt of the notice, the protocol doctors will be expected to make an appointment within the timeframe outline in the protocol. Upon receipt of this notice the secretaries or clerks at the site will be asked to insert a treatment sheet in the doctor's chart. This sheet will be used to assess the timeliness of the first visit after notification, about the adherence of protocol doctors to protocol treatment.
Other: Treatment Protocol
Standard care doctors, who will not know the details of this protocol, will decide on their own if and when to see the patient. Upon receipt of this notice the secretaries or clerks at the site will be asked to insert a treatment sheet in the doctor's chart. This sheet will be used to assess types of medications and general pattern of treatment of the standard of care doctors.
Other: Standard of Care
Protocol treatment sites will be expected to see the patient within a pre-specified window of time. The doctors at that site will apply the treatment algorithm and will make decisions about response to treatment based on the algorithm and on specific patient answers to questionnaires. The treatment protocol will only be made available to IRBs, not to any site personnel before randomization. This was derived from a survey of rheumatologists in many countries and gastroenterologists, mostly in North America, who were asked multiple questions about how they would treat and follow up patients with suspected SIBO. Successful treatment is a response on GSS of no diarrhea plus a total GSS of \< 5.
Physicians randomly assigned to standard of care will also be informed of their patients who met eligibility criteria. They will not be aware of the detailed treatment protocol but will be informed of which medications are in the protocol eg antibiotics, prokinetics etc. They will be free to contact the patients at their convenience and to treat them in any way they deem suitable, preferably using these medications but at doses and frequencies according to their own wishes.
Determine if protocol treatment is effective
The primary outcome is the total Gastrointestinal Symptom Scale score. Each symptom carries a score from 0 (no symptoms) to 3 (severe). The maximum overall score is 33. An improvement in the score, ie a lower score, indicates an improvement in GI symptoms.
Time frame: 3 years
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