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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03588845




Registration number
NCT03588845
Ethics application status
Date submitted
10/05/2018
Date registered
17/07/2018
Date last updated
17/10/2019

Titles & IDs
Public title
The Small Intestine Bacterial Overgrowth Study Pilot
Scientific title
Pragmatic, Multicenter, Cluster, Cohort Randomized Controlled Treat-to-target Trial for Treatment of SIBO in SSc Pilot
Secondary ID [1] 0 0
CODIM-MBM-16-282
Universal Trial Number (UTN)
Trial acronym
SIBO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Sclerosis 0 0
Small Intestinal Bacterial Overgrowth 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Treatment Protocol
Other interventions - Standard of Care

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.


Other 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.

Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine if protocol treatment is effective
Timepoint [1] 0 0
3 years

Eligibility
Key inclusion criteria
- Clinical diagnosis of Scleroderma

- Internet access

- An email address

- Adequate computer literacy in order to fill out the online questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2021
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Saint Vincent's - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland

Funding & Sponsors
Primary sponsor type
Other
Name
Canadian Scleroderma Research Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT03588845
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Murray Baron, MD
Address 0 0
Country 0 0
Phone 0 0
514 340 8222
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03588845