NCT03588845

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 Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

2.1 years

First QC Date

May 10, 2018

Last Update Submit

October 16, 2019

Conditions

Systemic SclerosisSmall Intestinal Bacterial Overgrowth

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

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.

Other: Standard of Care

Interventions

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.

Protocol Treatment
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.

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

John's Hopkins

Baltimore, Maryland, 21224, United States

RECRUITING

Saint Vincent's

Melbourne, Australia

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Clinical ProtocolsStandard of Care

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationQuality Indicators, Health CareHealth Services Administration

Central Study Contacts

Murray Baron, MD

CONTACT

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

Kerry McKenna

CONTACT

5143408222kmckenna@jgh.mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 10, 2018

First Posted

July 17, 2018

Study Start

February 15, 2019

Primary Completion

April 1, 2021

Study Completion

September 1, 2021

Last Updated

October 17, 2019

Record last verified: 2019-10

Locations

AU(1)US(1)