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

NCT ID: NCT01497743

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Brief Summary

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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

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Conditions

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Scleroderma

Keywords

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Scleroderma gastrointestinal bloating reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Lactobacillus

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Lactobacillus

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Culturelle

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Dinesh Khanna, MD, MS

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Countries

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United States

Other Identifiers

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KhannaSN0000

Identifier Type: -

Identifier Source: org_study_id