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Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis (PRISS)

Primary Purpose

Scleroderma

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lactobacillus
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma focused on measuring Scleroderma, gastrointestinal, bloating, reflux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patient ≥18 years.
  2. Patients with SSc with moderate-to-severe distention/bloating on GIT 2. scale (scale score >1.00).
  3. Stable immunosuppressive therapy(ies) for ≥ 1 month.
  4. Stable PPI and/or other anti-reflux medications for ≥ 1 month.
  5. Stable calcium channel blocker for ≥ 1 month.
  6. Stable NSAID for ≥ 1 month.
  7. Stable dose of pro-motility agent for ≥ 1 month.

Exclusion criteria:

  1. Recent diagnosis for small intestinal bacterial overgrowth (SIBO) during last 1 month.
  2. Treatment with antibiotics within last 2 weeks.
  3. Currently receiving chemotherapy (pulse cyclophosphamide). It is acceptable to be on methotrexate, mycophenolate mofetil, hydroxychloroquine, or azathioprine.
  4. Severe diarrhea (Diarrhea scale score of ≥ 1.01; may suggest untreated SIBO).

  5. History of inherited or acquired immunodeficiency

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    placebo

    Probiotic

    Arm Description

    Subjects will be randomized into either the probiotic or placebo arm of the study at a 1:1 ratio. All randomized subjects will receive probiotic or matching placebo: 1 capsule orally twice daily, with meals) for the first 4 weeks. There will be a 6-week washout period, followed by 4 weeks of the alternate treatment. The subject will not be on study medication during this washout period.

    Subjects will be randomized into either the probiotic or placebo arm of the study at a 1:1 ratio. All randomized subjects will receive probiotic or matching placebo: 1 capsule orally twice daily, with meals) for the first 4 weeks. There will be a 6-week washout period, followed by 4 weeks of the alternate treatment. The subject will not be on study medication during this washout period.

    Outcomes

    Primary Outcome Measures

    1. Proportion of patients with improvement in distention/bloating scale ≥ 0.14 at the end of 4 weeks. A change of 0.14 is the minimally important difference for this scale(9)

    Secondary Outcome Measures

    Full Information

    First Posted
    December 20, 2011
    Last Updated
    December 20, 2016
    Sponsor
    University of Michigan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01497743
    Brief Title
    Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis
    Acronym
    PRISS
    Official Title
    Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    February 2013 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Organs of the gastrointestinal tract include the mouth, throat, stomach, intestines, and anus. Patients with scleroderma often have GIT disorders. GIT disorders can be severely debilitating and even life-threatening. Some problems associated with GIT disorders may include heartburn, loss of voice or hoarseness, ulcers (open sores), difficulty swallowing, constipation, diarrhea, malabsorption (impaired absorption of nutrients from the GI tract), diminished peristalsis (decreased in the wavelike motion in the muscles of the intestines), and the inability to control your bowel movements. Probiotics are the "good bacteria" normally found in your digestive tract. Our group is looking at whether or not taking daily probiotics (lactobacillus) can help alleviate some of these symptoms in scleroderma patients that have GIT disorders.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Scleroderma
    Keywords
    Scleroderma, gastrointestinal, bloating, reflux

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will be randomized into either the probiotic or placebo arm of the study at a 1:1 ratio. All randomized subjects will receive probiotic or matching placebo: 1 capsule orally twice daily, with meals) for the first 4 weeks. There will be a 6-week washout period, followed by 4 weeks of the alternate treatment. The subject will not be on study medication during this washout period.
    Arm Title
    Probiotic
    Arm Type
    Active Comparator
    Arm Description
    Subjects will be randomized into either the probiotic or placebo arm of the study at a 1:1 ratio. All randomized subjects will receive probiotic or matching placebo: 1 capsule orally twice daily, with meals) for the first 4 weeks. There will be a 6-week washout period, followed by 4 weeks of the alternate treatment. The subject will not be on study medication during this washout period.
    Intervention Type
    Drug
    Intervention Name(s)
    Lactobacillus
    Other Intervention Name(s)
    Culturelle
    Intervention Description
    All randomized subjects will receive probiotic or matching placebo: 1 capsule orally twice daily, with meals) for the first 4 weeks. There will be a 6-week washout period, followed by 4 weeks of the alternate treatment. The subject will not be on study medication during this washout period.
    Primary Outcome Measure Information:
    Title
    1. Proportion of patients with improvement in distention/bloating scale ≥ 0.14 at the end of 4 weeks. A change of 0.14 is the minimally important difference for this scale(9)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patient ≥18 years. Patients with SSc with moderate-to-severe distention/bloating on GIT 2. scale (scale score >1.00). Stable immunosuppressive therapy(ies) for ≥ 1 month. Stable PPI and/or other anti-reflux medications for ≥ 1 month. Stable calcium channel blocker for ≥ 1 month. Stable NSAID for ≥ 1 month. Stable dose of pro-motility agent for ≥ 1 month. Exclusion criteria: Recent diagnosis for small intestinal bacterial overgrowth (SIBO) during last 1 month. Treatment with antibiotics within last 2 weeks. Currently receiving chemotherapy (pulse cyclophosphamide). It is acceptable to be on methotrexate, mycophenolate mofetil, hydroxychloroquine, or azathioprine. Severe diarrhea (Diarrhea scale score of ≥ 1.01; may suggest untreated SIBO). History of inherited or acquired immunodeficiency -

    12. IPD Sharing Statement

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    Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis

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