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

This study is not yet open for participant recruitment.
Verified December 2011 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Dinesh Khanna, MD, MS, University of Michigan
ClinicalTrials.gov Identifier:
NCT01497743
First received: December 20, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Improvement in Distention/Bloating Scale ≥ 0.14 at the End of 4 Weeks.
 Drug: Lactobacillus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Scleroderma
U.S. FDA Resources

Further study details as provided by University of Michigan:

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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: February 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
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.
 Drug: Lactobacillus
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.
Other Name: Culturelle
Active Comparator: Probiotic
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.
 Drug: Lactobacillus
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.
Other Name: Culturelle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

    -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497743

Contacts
Contact: Dinesh Khanna, MD 734-763-3110 khannad@umich.edu
Contact: Elena Schiopu, MD 734-763-3110 eschiopu@umich.edu

Locations
United States, Michigan
University of Michigan Health System Not yet recruiting
Ann Arbor, Michigan, United States, 48118
Contact: Julie Konkle, BSN     734-763-3110     jkonkle@umich.edu    
Contact: Leah Kramer, BS     734-763-3110     ltroma@umich.edu    
Principal Investigator: Dinesh Khanna, MD            
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Dinesh Khanna, MD, MS, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01497743     History of Changes
Other Study ID Numbers: KhannaSN0000
Study First Received: December 20, 2011
Last Updated: December 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
Scleroderma
gastrointestinal
bloating
reflux

Additional relevant MeSH terms:
Dilatation, Pathologic
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
 Pathological Conditions, Anatomical
Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013