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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01497743
Recruitment Status : Withdrawn
First Posted : December 22, 2011
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Scleroderma Drug: Lactobacillus Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis
Study Start Date : February 2012
Estimated Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

More Information

Responsible Party: Dinesh Khanna, MD, MS, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01497743     History of Changes
Other Study ID Numbers: KhannaSN0000
First Posted: December 22, 2011    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016

Keywords provided by Dinesh Khanna, MD, MS, University of Michigan:
Scleroderma
gastrointestinal
bloating
reflux

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