Recruiting

T2T vs. Standard Care

Sponsor:

Canadian Scleroderma Research Group

Code:

NCT03588845

Conditions

Systemic Sclerosis

Small Intestinal Bacterial Overgrowth

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Treatment Protocol

Standard of Care

Study Details

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

Conditions

Systemic Sclerosis

Small Intestinal Bacterial Overgrowth

Study ID

NCT03588845

Start date

Feb 15, 2019

Status verified date

Oct, 2019

Completion date

Sep 1, 2021

Anticipated

Primary completion date

Apr 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Protocol Treatment

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: Standard of Care

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.

Interventions

Treatment Protocol

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.

Standard of Care

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.

Primary outcome measure

  • Determine if protocol treatment is effective [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Murray Baron, MD

514 340 8222mbaron@rhu.jgh.mcgill.ca

Kerry McKenna

5143408222kmckenna@jgh.mcgill.ca

Locations

John's Hopkins

Recruiting

Baltimore, Maryland, United States, 21224

More Information

Sponsor

Canadian Scleroderma Research Group

Last update posted

Oct 17, 2019

Last verified

Oct, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Scleroderma Research Group on 2019-10-17.