Clinical Trials

5 studies in Gastrointestinal Disorders

1. Trial of Montelukast in Eosinophilic Esophagitis Rochester, MN View Summary
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   Trial of Montelukast in Eosinophilic Esophagitis

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   We will randomize in a double blind manner 60 consecutive consenting patients being evaluated at the three Mayo Clinic Medical Centers with EE to montelukast 20mg daily or placebo daily for six months? time. Patients will be in remission after treatment with topical fluticasone therapy before enrollment. Patients will fill out a validated dysphagia and side effect questionnaire before, during, and at the end of therapy.

   NCT ID:

   NCT00511316

   IRB Number:

   06-003373

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   Who can I contact for additional information about this study?

   Rochester: Debra M. Geno, CCRP 507-538-0367
                       
   
   
   

2. A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome Rochester, MN View Summary
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   A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This study is being done to see if Lyrica helps people with irritable bowel syndrome, otherwise known as "IBS". Lyrica is the trade name for pregabalin, which was first approved by the FDA in June 2005 and has been available through prescription since fall 2005, and is marketed by Pfizer. Lyrica is known to have clinical efficacy treating pain disorders including IBS-related conditions such as fibromyalgia.

   NCT ID:

   NCT00977197

   IRB Number:

   09-004404

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   Who can I contact for additional information about this study?

   Rochester: Annie Almazar 507-284-5010
                       
   
   
   

3. Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination Rochester, MN View Summary
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   Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Rumination is an upper gastrointestinal (GI) disorder characterized by the frequent regurgitation of recently ingested food. Very little is understood about the nature and treatment of this disorder. The act of regurgitation in rumination involves the opening of the upper esophageal sphincter and the muscular contraction of the abdomins rectus. Behavioral treatment of these symptoms is the clinical intervention of choice; however, only uncontrolled case documentation exists to support its effectiveness. However, an effective behavioral mechanism may be relaxation of the muscles. From a behavioral standpoint, muscular relaxation is incompatible with the necessary muscular contraction for rumination. To date, single case documentation and few designed single case studies have examined the clinical effectiveness of behavioral interventions for GI rumination. In the current study, the investigators seek to examine the effectiveness of two behavioral relaxation interventions for GI rumination through a treatment as usual paradigm (proposed N = 20). Our primary goals are to examine the clinical effectiveness of these interventions in symptom reduction at 1- and 3-month follow-up.

   NCT ID:

   NCT01576302

   IRB Number:

   11-008528

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   Who can I contact for additional information about this study?

   Rochester: Richard J Seime, Ph.D 507-284-2649
                       Jennifer M. Craft, Ph.D. 507 284 5849
   
   
   

4. Endoscopic Full Thickness Biopsy, Gastric Wall. Rochester, MN View Summary
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   Endoscopic Full Thickness Biopsy, Gastric Wall.

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Our group has studied a new endoscopic method using a submucosal endoscopy with mucosal flap (SEMF) technique to acquire full thickness gastric tissues successfully and safely in preclinical studies. The proposed study will assess the efficacy and safety of the innovative endoscopic technique for the acquisition of full thickness gastric muscle wall biopsies. Having access to full thickness biopsies will allow an increased understanding of the pathophysiology of gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis, pseudoobstruction and other motility disorders. This information is essential to development of more targeted and effective therapy than currently available. Despite the high prevalence of functional gastrointestinal disorders and its significant impact on social and health care costs, the underlying cause is not well understood and there is no effective specific treatment to successfully alleviate patient symptoms.

   NCT ID:

   NCT01650714

   IRB Number:

   12-000714

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   Who can I contact for additional information about this study?

   Rochester: Elizabeth Rajan, MD 507-266-3972
                       Mary A Knipschield 507-266-3972
   
   
   

5. 12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients With Chronic Idiopathic Constipation Rochester, MN View Summary
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   12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients With Chronic Idiopathic Constipation

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with Chronic Idiopathic Constipation.

   NCT ID:

   NCT01833065

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   Who can I contact for additional information about this study?

   - Mayo Clinic Cancer Center - Phone: 507-538-7623 - Research Volunteer Program - Phone: 1-800-664-4542 (toll-free) Email: clinicaltrials@mayo.edu - International Research - Phone: 507-284-8884 Email: intl.mcr@mayo.edu