The Small Intestine Bacterial Overgrowth Study Pilot

Systemic Sclerosis Clinical Trial

— SIBO  

Official title:

Pragmatic, Multicenter, Cluster, Cohort Randomized Controlled Treat-to-target Trial for Treatment of SIBO in SSc Pilot

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03588845
• Other study ID #: CODIM-MBM-16-282
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2019
• Source: Canadian Scleroderma Research Group
• Contact: Murray Baron, MD
• Phone: 514 340 8222
• Email: mbaron[@]rhu.jgh.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Small Intestinal Bacterial Overgrowth
• Systemic Sclerosis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Australia	Saint Vincent's	Melbourne
United States	John's Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Scleroderma Research Group	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years