The Small Intestine Bacterial Overgrowth Study Pilot
The Small Intestine Bacterial Overgrowth Study Pilot
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:

 1. Determine if REBs perceive any major issues regarding the full trial.

 2. Determine if the sites are consenting all eligible patients.

 3. Determine the signing rate of consent.

 4. Determine patient adherence to web access for questionnaires.

 5. Assess the method for detecting eligible cases from web questionnaires.

 6. Assess whether physician notifications are being sent out quickly after detecting
 eligible cases.

 7. Assess the timeliness and completeness of physician receipt of notification of patient
 eligibility.

 8. Assess physician adherence to treatment protocol:

 1. how soon protocol patients are brought in to see doctor after receipt of notice.

 2. does doctor record what he does accurately.

 3. does he/she schedule return visits according to protocol.

 4. does he/she use in office questionnaires for treat to target.

 5. does he/she base decisions on these questionnaires.

 6. does he/she follow algorithm sequentially.

 9. For control sites,

 1. Record how soon protocol patients are brought in to see doctor after receipt of
 notice.

 2. 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.
Inclusion Criteria:

 -  Clinical diagnosis of Scleroderma

 -  Internet access

 -  An email address

 -  Adequate computer literacy in order to fill out the online questionnaires.

 Exclusion Criteria:

 -  Allergy to protocol drugs

 -  Concomitant disease that would make it unlikely that they will survive for one year

 -  Use of substances known to cause diarrhea

 -  History of antibiotics in the 12 weeks prior to inclusion

 -  History of intestinal pseudo-obstruction

 -  Inability to complete the symptom questionnaires

 -  No functional level of written & spoken languages

 -  Previous C. Dificile infection

 -  Previous gastrointestinal surgery

 -  Prolonged QT interval

 -  Pregnancy or breastfeeding