Systemic SclerosisSIBONCT03588845
The Small Intestine Bacterial Overgrowth Study Pilot
A study testing Treatment Protocol in people with Systemic Sclerosis and Small Intestinal Bacterial Overgrowth, run by Canadian Scleroderma Research Group at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Small Intestinal Bacterial Overgrowth
- What is being tested?
- Treatment Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Feb 2019to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Scleroderma
- Internet access
- An email address
- Adequate computer literacy in order to fill out the online questionnaires.
Who cannot join
- 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
Show all 11Show fewer
- No functional level of written \& spoken languages
- Previous C. Dificile infection
- Previous gastrointestinal surgery
- Prolonged QT interval
- Pregnancy or breastfeeding
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
John's Hopkins
Baltimore, Maryland, 21224
Margaret Sampedro
Australia1 site, 1 recruiting
- Recruiting
Saint Vincent's
Melbourne
Katherine Ellis
About this study
Official title: Pragmatic, Multicenter, Cluster, Cohort Randomized Controlled Treat-to-target Trial for Treatment of SIBO in SSc 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
Read the 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:
- Determine if REBs perceive any major issues regarding the full trial.
- Determine if the sites are consenting all eligible patients.
- Determine the signing rate of consent.
- Determine patient adherence to web access for questionnaires.
- Assess the method for detecting eligible cases from web questionnaires.
- Assess whether physician notifications are being sent out quickly after detecting eligible cases.
- Assess the timeliness and completeness of physician receipt of notification of patient eligibility.
- Assess physician adherence to treatment protocol:
- how soon protocol patients are brought in to see doctor after receipt of notice.
- does doctor record what he does accurately.
- does he/she schedule return visits according to protocol.
- does he/she use in office questionnaires for treat to target.
- does he/she base decisions on these questionnaires.
- does he/she follow algorithm sequentially.
- For control sites,
- Record how soon protocol patients are brought in to see doctor after receipt of notice.
- 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.
- Being tested
- Treatment Protocol, Standard of Care
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ProtocolOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Protocol Treatment | Other | 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. Receives: Other: Treatment Protocol |
| Standard of Care | Other | 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if protocol treatment is effective
The primary outcome is the total Gastrointestinal Symptom Scale score. Each symptom carries a score from 0 (no symptoms) to 3 (severe). The maximum overall score is 33. An improvement in the score, ie a lower score, indicates an improvement in GI symptoms.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start15 Feb 2019
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Scleroderma Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Murray Baron, Canadian Scleroderma Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588845
- Sponsor's protocol ID
- CODIM-MBM-16-282
- Acronym
- SIBO
- Status last verified
- Oct 2019
- First submitted
- 10 May 2018
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic, Multicenter, Cluster, Cohort Randomized Controlled Treat-to-target Trial for Treatment of SIBO in SSc Pilot
- ClinicalTrials.gov ID
- NCT03588845
- Acronym / sponsor ID
- SIBO / CODIM-MBM-16-282
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Canadian Scleroderma Research GroupUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine if REBs perceive any major issues regarding the full trial.
- Determine if the sites are consenting all eligible patients.
- Determine the signing rate of consent.
- Determine patient adherence to web access for questionnaires.
- Assess the method for detecting eligible cases from web questionnaires.
- Assess whether physician notifications are being sent out quickly after detecting eligible cases.
- Assess the timeliness and completeness of physician receipt of notification of patient eligibility.
- Assess physician adherence to treatment protocol:
- how soon protocol patients are brought in to see doctor after receipt of notice.
- does doctor record what he does accurately.
- does he/she schedule return visits according to protocol.
- does he/she use in office questionnaires for treat to target.
- does he/she base decisions on these questionnaires.
- does he/she follow algorithm sequentially.
- For control sites,
- Record how soon protocol patients are brought in to see doctor after receipt of notice.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Protocol Treatment | Other | Other: Treatment ProtocolIf 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. |
| Standard of Care | Other | Other: Standard of CareStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Scleroderma
- Internet access
- An email address
- Adequate computer literacy in order to fill out the online questionnaires.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment ProtocolProtocol 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 | Protocol Treatment |
| Standard of CarePhysicians 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. | Other | Standard of Care |
Primary outcome
Determine if protocol treatment is effective
Time frame: 3 years
The primary outcome is the total Gastrointestinal Symptom Scale score. Each symptom carries a score from 0 (no symptoms) to 3 (severe). The maximum overall score is 33. An improvement in the score, ie a lower score, indicates an improvement in GI symptoms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Protocol in people with Systemic Sclerosis and Small Intestinal Bacterial Overgrowth, run by Canadian Scleroderma Research Group at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Murray Baron, MD (514 340 8222 ext. 23422, mbaron@rhu.jgh.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if protocol treatment is effective (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.