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

Scleroderma Clinical Trial

— PRISS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01497743
• Other study ID #: KhannaSN0000
• Status: Withdrawn
• Phase: Phase 4
• First received: December 20, 2011
• Last updated: December 20, 2016
• Start date: February 2012

Study information

• Verified date: December 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

Intervention

Drug:
• Lactobacillus
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No