The Small Intestine Bacterial Overgrowth Study Pilot

Status unconfirmed · Not applicable

Conditions studied: Systemic Sclerosis, Small Intestinal Bacterial Overgrowth

In brief

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

Key facts

Study ID

NCT03588845

Run by

Canadian Scleroderma Research Group

People needed

500

Starts

2019-02-15

Expected to finish

2021-09-01

Last updated by the study team

2019-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of Scleroderma
• Internet access
• An email address
• Adequate computer literacy in order to fill out the online questionnaires.

You may not qualify if…

• 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

Where it is running

• John's Hopkins — Baltimore, Maryland, United States (enrolling)
• Saint Vincent's — Melbourne, Australia (enrolling)

Full record on ClinicalTrials.gov

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