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



Status:Not yet recruiting
Conditions:Neurology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Neurology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:February 2012
Contact:Dinesh Khanna, MD
Email:khannad@umich.edu
Phone:734-763-3110

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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.


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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Ann Arbor, Michigan 48109
(734) 936-4000
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