Clinical trial NCT03588845: The Small Intestine Bacterial Overgrowth Study Pilot
Official title: Pragmatic, Multicenter, Cluster, Cohort Randomized Controlled Treat-to-target Trial for Treatment of SIBO in SSc Pilot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Sclerosis
Small Intestinal Bacterial Overgrowth
Lead sponsor: Canadian Scleroderma Research Group
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-07-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed 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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine if protocol treatment is effective
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: John's Hopkins
state: Maryland
city: Melbourne
country: Australia
facility: Saint Vincent's
Study officials:
References: