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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan

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

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