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UCLA Division of Digestive Diseases


Clinical Trials

Weight Loss After Bariatric Surgery: The Role of Changes in Appetite and Food Preferences

If you are a woman thinking about weight loss surgery, you may be eligible to participate in this research study. The purpose of the study is to explore the role that the brain activity -related to appetite, eating habits and food preferences- plays in weight loss after bariatric surgery and if a brain MRI could predict who will be successful in losing weight after surgery.

  1. You must be a woman, between 18-55 years of age, right handed, and have no neurological or significant psychiatric history.
  2. You must be eligible and approved for undergoing weight loss surgery (gastric bypass or sleeve gastrectomy).
  3. Participation involves a screening visit and 3 MRIs performed before, 1 month and 6 months after weight loss surgery. Blood samples, body composition and information about food preferences/eating habits will also be collected.
  4. Compensation: Up to $240, receive a free picture of your brain and free parking during the study visits.

This study is conducted by Dr. Claudia Sanmiguel, from the UCLA Program for Ingestive Behavior and Obesity and by Drs. Erik Dutson and Yijun Chen, from the UCLA Center for Obesity and METabolic Health (COMET).

If interested, please call (310) 206-1758 or (310) 825-3287.

Protocol ID: IRB#13-001552 UCLA IRB Approved Date: 10/9/2014 through 10/8/2015 Committee: Medical IRB 3

Scor Study: Exploring the Connection Between the Brain and Gut in Healthy Subjects and IBS Patients

You may qualify to participate in a UCLA research study conducted by Dr. Emeran Mayer. The purpose of this study is to learn more about how IBS develops, which may lead to the development of diagnostic tests and treatments.

  1. We are looking for men and women, age 18 to 55 years old, lean or obese, healthy or with IBS symptoms.
  2. This study consists of 2-3 visits and your participation consists of:
    1. Clinical assessment, questionnaires, saliva, blood, stool and urine samples
    2. Heat sensitivity testing
    3. Brain MRI
    4. DEXA scan for abdominal fat and blood draw
  3. Compensation up to $160.

If interested, please call (310) 206-8545 or check out our website at: http://www.uclacns.org

Protocol ID: IRB# 12-001802 UCLA IRB Approval Date: 1/8/2015 through 12/10/2015 Committee: Medical IRB 3 

Investigational Research Study of a Natural, Herbal Remedy for IBS Symptoms

Do you suffer from chronic abdominal pain, discomfort and bloating? Do you experience diarrhea or constipation, or even both? You may have irritable bowel syndrome, or IBS. If so you may qualify for an investigational research study of a natural, herbal remedy for IBS symptoms.

To qualify to participate, you must:

  1. Be female
  2. Be between the ages of 18-65
  3. Suffer from IBS symptoms

Qualified participants will receive study herbal product medication or placebo, study related testing and a physical exam at no cost. Compensation may be provided for time and travel and insurance is not needed.

Ask us if you qualify or find out more at (877) 906-7797 or visit www.myclinicaltrial.com/UCLA

Protocol ID:IRB#14-000333 UCLA IRB Approved Approval Date: 3/12/2015 Through: 1/14/2016 Committee: Medical IRB 3 

Phase III, Double Blind, Placebo-Controlled Multicenter Study of the Efficacy and Safety of Etrolizumab during Induction and Maintenance in Patients with Moderate to Severe Active Ulcerative Colitis who are Refractory to or Intolerant of TNF Inhibitors.

The purpose of this study is to determine whether etrolizumab is a safe and effective treatment for ulcerative colitis in patients with moderately to severely active ulcerative colitis who have previously been treated with Anti-TNF inhibitors or biologics and their condition did not improve. Etrolizumab is designed to work by blocking the binding of certain white blood cells to the lining of the GI tract. By blocking the binding of the cells it is thought to reduce inflammation caused by ulcerative colitis.

The screening period will last up to 28 days, the Induction Phase will last 14 weeks and the Maintenance Phase will last 52 weeks. The follow-up safety phase will last 12 weeks which is the end of the study. Patients will be asked to take part in a follow-up 92 week progressive multifocal leukoencephalopathy (PML) study where patients will not receive study drug nor will be required to visit the study site. Instead visits will be over the phone every 6 months. Approximately 800 patients will be recruited from approximately 200 study sites globally. 

Protocol number: GA28950
Sponsor: F. Hoffmann-La Roche Ltd
Principal Investigator: Daniel Hommes, MD, PhD
If interested please contact Stephanie Okimoto at the UCLA Clinical and Translational Research Center (CTRC) at SOkimoto@mednet.ucla.edu  

Anti-TNF Response Diagnostic Proposal

This is an Investigator Initiated Study where we are interested in understanding how baseline biopsy gene expression relates to clinical response to Anti-TNF agents as an approach to developing better and more targeted therapeutics in IBD. We have identified genes predicting TNF-Non-Response (TNF-NR) using published data for patients with Crohn's and ulcerative colitis prior to treatment with infliximab with documented response as measured by mucosal healing. The study is only 3 visits; at the first visit the patient meets with his IBD physician to discuss starting either Remicade or Humira as this patient needs to optimize his IBD therapy. At the 2nd visit the patient will have a colonoscopy or flexible sigmoidoscopy prior to starting the Anti-TNF. The last visit is covered by the research where at 10 weeks after being on either Remicade or Humira the patient will have a 2nd scope to determine mucosal healing on the new biologic.

Qualifier: Patients need to be naive to all biologics.
Total number of patients to be enrolled: 22
Principal Investigator: Daniel Hommes, MD, PhD
Sponsor: Genentech

If interested please call Ellen Kane, RN 310-206-5706 or ekane@mednet.ucla.edu

Vedolizumab (Anti-integrin a44B7) Response Diagnostic Proposal

Vedolizumab was recently approved by the FDA, it is a humanized monoclonal antibody that recognizes specifically the a4?7-integrin, a cell-surface mucosal addressin cell adhesion molecule 1 (MAdCAM-1) on the intestinal vasculature. By inhibiting the interaction of a4?7 and MAdCAM-1 Vedolizumab is expected to block lymphocyte trafficking to the intestinal mucosa of IBD patients. Our aim is to evaluate the efficacy of circulating (serum) microRNAs as biomarkers in UC and Crohn's patients following Vedolizumab treatment and examine the mucosal gene expression profile in UC and Crohn's patients following Vedolizumab treatment.

This is a 5 visit study; at the screening visit patients will discuss a medication change to Vedolizumab due to failing or been intolerant to 5-ASA, 6MP or Azathioprine. The baseline visit includes a colonoscopy or flexible sigmoidoscopy prior to starting Vedolizumab. At week 2 and week 6 after starting Vedolizumab patients will have a blood draw only. After 10 weeks of Vedolizumab patients will return for a follow-up scope to measure mucosal healing. All visits are standard of care with the exception of the 10 week post scope visit which is covered by the study.

Principal Investigator: Daniel Hommes, MD, PhD

If interested please call Ellen Kane, RN 310-206-5706 or ekane@mednet.ucla.edu 

COORS - The Cirrhosis Outpatient Optimization, Readmission & Safety Study

 This is a prospective, randomized controlled trial comparing two strategies of post discharge care in patients with cirrhosis-related hospitalizations. Patients meeting the inclusion criteria will be randomized to either the Vivify Home Monitoring kit or standard of care. Those going home with the Vivify kit will for 30 days log on to the tablet and following the prompts input their weight, blood pressure, temperature, heart rate and pulse oximetry. The patient and/or family members will be trained on the kit before discharge. Abnormal question responses and vital sign parameters are associated with medium or high alerts that will be sent to the liver care coordinator. A face to face teleconference call via tablet will be completed for patient assessment and appropriate triage according to the protocol. In the case where the patient's symptoms require urgent care the patient will be directed to the emergency department. Those patients randomized to standard of care will be discharged with contact phone numbers and a return to clinic appointment in 30 days. All patients will fill out questionnaires measuring their quality of life, work productivity health status and medication adherence.

This study is offered at patients admitted at UCLA Ronald Reagan Hospital and the VA Medical Center where we aim to enroll 120 patients.

Primary objective: To demonstrate that care incorporating home monitoring and liver care coordination program will decrease 30-day readmission rates as compared to conventional care.
Principal Investigator: Daniel Hommes, MD, PhD
Sponsor: Vivify Health Inc.

If interested please call Ellen Kane, RN 310-206-5706 or ekane@mednet.ucla.edu 

Development of a Novel Biomarker for Liver Fibrosis

Preliminary data suggest that cholesterol and retinoid metabolism are tightly linked in these cells, prompting us to examine this relationship in the setting of obesity and diabetes. Specific aims have been developed to test the following hypotheses: 1) Quantifying liver fibrosis as a continuous variable will predict clinically significant outcomes in fatty liver disease related to metabolic syndrome; and 2) In a prospective cohort of patients, quantified liver fibrosis will correlate more strongly with tissue and circulating retinoid metabolites than with other, commonly measured serum markers.

This study offers a major innovation by performing accurate fibrosis quantification without any human intervention or post-analysis correction. In addition, we can test whether subtle differences in quantified fibrosis impact outcome for a given clinical stage of disease severity, possible because we are measuring fibrosis as a continuous variable, not a categorical one. We are using a disease-independent approach to evaluate anti-fibrotic agents in clinical trials and for evaluating other diagnostic markers.

We are also testing whether a novel diagnostic marker, retinoid storage, correlates with liver disease progression in humans. We propose to extend the study to address fatty liver disease, NAFLD/NASH, in the context of adult patients with abnormal liver tests, fatty liver identified on imaging, physical obesity, and diabetes. Clinical variables and outcomes to be recorded and analyzed include: morphology (age, gender, ethnicity, height, weight/BMI, waist circumference and steatosis on imaging studies); biochemistry (glucose intolerance or diabetes, complete blood counts, metabolic panels, liver function tests, cholesterol panels, insulin, and vitamin D levels); clinical outcomes (date of liver disease diagnosis and estimated duration of disease, listing on liver transplant list, occurrence of liver transplant or re-transplant, presence of cancer, and death); medications (current or previous prescribed, herbals, supplements taken for diabetes, dyslipidemia, hypertension, cardiovascular disease, or stroke); and disease exacerbation/modifying factors (presence of other chronic liver diseases such as NASH + HIV, liver toxins such as alcohol consumption, weight gain, or worsening diabetes).

Data will be collected from subjects who complete eight visits over a 24-month period. Assessments will include morphometric measurements, blood collection for laboratory analysis and completion of dietary history report.

  1. You must be 18 years or older
  2. Both genders are eligible
  3. At least one liver function test abnormality and body mass index >20

This study is conducted by Dr. Simon Beaven and Stephanie Okimoto.

If interested, please contact Dr. Beaven at 310-794-7788 or Stephanie Okimoto at the UCLA Clinical and Translational Research Center (CTRC) at SOkimoto@mednet.ucla.edu

Study start date is May 2015 and estimated primary completion date is April 2016. ClinicalTrials.gov identifier is NCT02348814.

Treating Weight Gain After Bariatric Surgery

If you have undergone roux-en-y gastric bypass surgery and are suffering from weight gain, you will be eligible for this study. The purpose of the study is to explore the effects of a novel endoscopic treatment on reestablishing weight loss and to examine the effects of the procedure on the hormones that govern eating habits and glucose metabolism.

  1. We are looking for men and women, age 18 to 70 years old who have undergone gastric bypass surgery and have experienced weight regain.
  2. This study consists of 3 visits and your participation consists of:
    1. Clinical assessment, questionnaires, blood samples, body measurements
    2. Endoscopic procedure

If interested, please call (310) 267-3636.

Endoscopic Sleeve Gastroplasty

The endoscopic sleeve gastroplasty procedure is a new technique that constricts the stomach using transoral endoscopy without the need for surgery. The stomach is sutured internally and reshaped to form a sleeve and thus reduce its capacity. This results in feeling fuller with less food, and avoids the risks and recovery time associated with traditional surgery. We are pleased to now be performing this procedure and are studying its effects on hunger, satiety, and eating behavior.

We are looking for:

  1. We are looking for men and women, age 18 to 70 years old with a BMI of >30
  2. Your participation consists of:
    1. Nutrition and dietary counseling
    2. Psychological counseling
    3. Endoscopic procedure
    4. Clinical assessments and questionnaires

If interested, please call (310) 267-3636.

UCLA Asian Liver Program Clinical Trials

The team of physicians at the UCLA Asian Liver Program participate in numerous clinical trials. The clinical trials can cover acute liver failure, hepatitis, and more.

To learn more call Val Peacock, RN at (310) 794-6067 or click here to see current UCLA Asian Liver Program clinical trials »

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