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

NCT01497743 | Withdrawn Phase 4

• 1 other identifier: KhannaSN0000
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Scleroderma

Keywords

Scleroderma; gastrointestinal; bloating; reflux

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

placebo

PLACEBO COMPARATOR

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.

Drug: Lactobacillus

Probiotic

ACTIVE COMPARATOR

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.

Drug: Lactobacillus

Interventions

Lactobacillus 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.

Also known as: Culturelle

Probiotic; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

MeSH Terms

Conditions

Scleroderma, Diffuse; Gastroesophageal Reflux

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 22, 2011
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Last Updated: December 22, 2016

Record last verified: 2016-12