Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- University of Michigan
- Primary Endpoint
- 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)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patient ≥18 years.
- •Patients with SSc with moderate-to-severe distention/bloating on GIT
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Lactobacillus (Drug)
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.
Intervention: Lactobacillus (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Dinesh Khanna, MD, MS
Associate Professor
University of Michigan