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

This study is not yet open for participant recruitment.

Verified December 2011 by University of Michigan

Sponsor:

Information provided by (Responsible Party):

Dinesh Khanna, MD, MS, University of Michigan

ClinicalTrials.gov Identifier:

NCT01497743

First received: December 20, 2011

Last updated: NA

Last verified: December 2011

History: No changes posted

Tracking Information

First Received Date ^ICMJE

December 20, 2011

Last Updated Date

December 20, 2011

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Improvement in Distention/Bloating Scale ≥ 0.14 at the End of 4 Weeks.

Intervention ^ICMJE

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.

Other Name: Culturelle

Study Arm (s)

Placebo Comparator: 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: Drug: Lactobacillus
Active Comparator: 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: Drug: Lactobacillus

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patient ≥18 years.
Patients with SSc with moderate-to-severe distention/bloating on GIT 2. 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

-

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dinesh Khanna, MD	734-763-3110	khannad@umich.edu
Contact: Elena Schiopu, MD	734-763-3110	eschiopu@umich.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01497743

Other Study ID Numbers ^ICMJE

KhannaSN0000

Has Data Monitoring Committee

Responsible Party

Dinesh Khanna, MD, MS, University of Michigan

Study Sponsor ^ICMJE

University of Michigan

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

University of Michigan

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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