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

Study Overview
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Brief Summary
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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.

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

Conditions
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Scleroderma

Intervention / Treatment
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* Drug: Lactobacillus


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>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<br>* 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.<br>* Other names: Culturelle;|
| Active Comparator: Probiotic<br>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<br>* 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.<br>* Other names: Culturelle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scleroderma, gastrointestinal, bloating, reflux