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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Dinesh Khanna, MD, MS, University of Michigan
ClinicalTrials.gov Identifier:
NCT01497743
First received: December 20, 2011
Last updated: June 6, 2014
Last verified: June 2014

December 20, 2011
June 6, 2014
February 2012
February 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01497743 on ClinicalTrials.gov Archive Site
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Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis
Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Improvement in Distention/Bloating Scale ≥ 0.14 at the End of 4 Weeks.
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
  • 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.
    Intervention: Drug: Lactobacillus
  • 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.
    Intervention: Drug: Lactobacillus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
February 2013   (final data collection date for primary outcome measure)

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

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Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01497743
KhannaSN0000
No
Dinesh Khanna, MD, MS, University of Michigan
University of Michigan
Not Provided
Not Provided
University of Michigan
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP