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

Phase 4

Withdrawn

• Conditions: Scleroderma
• Interventions: Drug: Lactobacillus

• Registration Number: NCT01497743
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-22
• Study Start: 2012-02
• Primary Completion: 2013-02
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Lactobacillus	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.
Probiotic	Lactobacillus	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.

Primary Outcome Measures

Name	Time	Method
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