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Do You Have an Irritable Bowel, Abdominal Pain, Diarrhea or Constipation? You Might Have Irritable Bowel Syndrome (IBS). Are You Interested in Mind-Body Research?

If so, we invite you to participate in brain imaging research at the G. Oppenheimer Center for Neurobiology of Stress and Resilience. 

To participate, you must be:

1. Suffering from IBS symptoms, such as abdominal pain or discomfort and altered bowel habits, e.g. constipation or diarrhea
2. 18-60 years old
3. Right-handed
4. Not pregnant or breast feeding
5. No significant neurological or psychological medical history

Each visit will include the following:

1. An MRI
2. A blood and stool sample
3. You will also receive a digital image of your brain

Compensation:

• Women: Earn up to $620 for completing all 5 visits over 12 months at 3 month intervals

• Men: Earn up to $150 for a screening visit, an MRI, one stool and blood sample

This study is conducted by Emeran A. Mayer, MD, PhD, G. Oppenheimer Center for Neurobiology of Stress and Resilience.

If interested, please call Kimberly at (310) 825-7217 or kimberlygonzalez@mednet.ucla.edu

Protocol ID: IRB #15-001591 UCLA IRB Approval Date: 12/22/2016 through 10/20/2017 Committee: Medical IRB 3

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Effectiveness of Changing Dietary Fat on Weight Loss

We invite you to participate in a study to understand how a change in dietary fat influences the brain-gut perception of hunger, food satisfaction and weight loss. 

You must be:

1. 18-55
2. Right-handed
3. Have BMI between 25-44 kg/m²

During this study, your participation will last up to 14 weeks (including screen) and will include the following:

1. You will be instructed to follow a calorie-specific diet for 12 weeks.
2. There will be 8 clinic visits (including screen). Depending on the visit, responsibilities include: collection of blood, stool, and urine samples; maintaining a diary of food intake; having your body composition measured with DEXA (which uses a low level of X-rays) and/or Tanita; a completion of questionnaires related to your diet and well-being; and meetings with a registered dietitian every two weeks for the duration of the study.
3. Two MRIs of the brain, medical evaluations, questionnaires before the calorie-specific diet and after the 12-week calorie specific diet.

Compensation: Earn up to $275 and get a digital image of your brain. Study activity is free of charge and parking will be compensated.

This study is conducted by Arpana Gupta, PhD, G. Oppenheimer Center for Neurobiology of Stress and Resilience, in collaboration with Emeran A. Mayer, MD, PhD and in collaboration with Zhaoping Li, MD, PhD, UCLA Center for Human Nutrition.

If interested, please call Kimberly at (310) 825-7217 or kimberlygonzalez@mednet.ucla.edu and refer to the "avocado diet related brain-gut interactions in obesity study."

Protocol ID: IRB #16-000187 UCLA IRB Approval Date: 11/30/2016 through 11/29/2017 Committee: Medical IRB 3, and IRB #16-001157 UCLA IRB Approval Date: 1/30/2017 through 8/9/2017 Committee: Medical IRB 1

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Are Your Worried About Your Weight?

We invite you to participate in a study to understand how the gut influences the brains' perception of hunger and changes in food satisfaction.
You must be:

1. 18-55
2. Right-handed
3. Have BMI between 25-44

Participation involves:

1. Two visits involving an MRI of the brain, medical evaluations, questionnaires and blood and stool samples
2. Compensation: Earn up to $150 and get a digital image of your brain
3. Study activity is free of charge and parking will be compensated.

This study is conducted by Arpana Gupta, PhD, G. Oppenheimer Center for Neurobiology of Stress and Resilience, in collaboration with Emeran A. Mayer, MD, PhD.
If interested, please call Kimberly at (310) 825-7217 or kimberlygonzalez@mednet.ucla.edu and refer to the "brain-gut interactions in obesity study."

Protocol ID: IRB #16-000187 UCLA IRB Approval Date: 11/30/2016 through: 11/29/2017 Committee: Medical IRB 3

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Optimizing Fecal Calprotectin Monitoring (OptiCal): A Clinical Study Comparing CalproLab Against PhiCal and Evaluating Its Association with the Gut Microbiome

You can be part of a microbiome study to collect data using a one time stool test.

The purpose of this study is to:

• Analyze stool specimens to test and validate the CalproLab assay against the predicate PhiCal in order to determine performance characteristics.
• To correlate Calpro levels to the gut microbiome composition.

Study design:

• This study is a prospective case series during which patients with either Crohn’s disease or ulcerative colitis, celiac disease, irritable bowel syndrome (IBS) and healthy controls (N=175) will be invited to participate
• Participants will receive a home kit (with a plain white plastic cup for calprotectin sample collections) for stool sampling, which then will be returned and processed at Genova Diagnostics. All participants are required to complete a patient survey, which will be included in the collection kit.
• Participants will be recruited through the UCLA Vatche and Tamar Manoukian Division of Digestive Diseases
• Ages 4-65 years old
• All patients will have a confirmation of their diagnosis according to published clinical guidelines and standards of care using gold standard diagnostics (e.g. endoscopy)
• Stool specimens will be analyzed for fecal Calprotectin using both the CalproLab™ assay and the PhiCal™ assay
• No blood draws or other testing will be performed
• Patients will undergo a gut microbiome assessment utilizing the GI Effects™ 2200 Comprehensive Profile (Genova Diagnostics)

This study is conducted by Daniel Hommes, MD, PhD, director, clinical care and clinical research, UCLA Center for Inflammatory Bowel Diseases. IRB #16-001499, Approved through 10/13/17

If you have any questions or would like to participate, please contact Miriam Dvorsky at mdvorsky@mednet.ucla.edu or 310-206-3778

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Brain Stimulation for Food Cravings

Do you feel that your food cravings are taking over your New Year's resolution of eating healthier? If so, you can participate in a study to test the ability of a new therapy to control your food cravings.

To be eligible you must be:

1. Female
2. Right-handed
3. 18-40
4. Willing to test a form of brain stimulation that is safe, using an experimental medical device

Eligible participants will complete 11 visits over a period of four months where they will:

1. Undergo a medical evaluation, fill out questionnaires and provide urine samples and stool samples (optional)
2. Attend eight, 20-minute sessions of a novel, non-invasive, brain stimulation to enhance control over food cravings over 2-3 weeks
3. Have two MRIs of the brain
4. Compensation: earn up to $315
5. Study is free, complimentary parking will be provided and you will receive a picture of your brain

This study is conducted by Claudia Sanmiguel, MD, UCLA Ingestive Behavior and Obesity Program.

If you have questions or would like to participate, please contact Jean Stains, RN at 310-206-1758 or jstains@mednet.ucla.edu IRB # 15-001929, Approved through 2/22/18

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IBD Patient-Caregiver Study

We know the struggles of chronic disease can be difficult and can affect one's work productivity. Through this study, we ask for your help in understanding how coping with inflammatory bowel disease affects the daily lives of both the patient and his/her caregiver(s) in and how we can help improve life for both. The UCLA IBD patient-caregiver study will educate doctors, nurses, and the health care team to understand both the patient's and their caregivers' point of view in order to accommodate and to assure future quality care. Participants and their caregivers will be asked to do a 5-10-minute survey. A simple link via email will be sent to any willing participants to do at their convenience. Or, we would be happy to meet with the patients during their clinic visit.

If you have questions or would like to participate, please call Miriam Dvorsky or Dr. Aria Zand at 310-206-3778 or email them at mdvorsky@mednet.ucla.edu and azand@mednet.ucla.edu
IRB #15-001304

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Vulvodynia MRI Study: Profiles of Vulvodynia Behavioral, Genetic and Brain Biomarkers

You may qualify to participate in a UCLA research study conducted by Dr. Jennifer Labus and Dr. Andrea Rapkin. The purpose of this study is to better understand the physiology and genetic makeup of vulvodynia in order to develop more effective treatments.

1. We are looking for women, age 18 to 55 years old, diagnosed with vulvodynia and experience chronic pain at the opening of the vagina with or without intercourse. You must not be pregnant or breastfeeding.
2. This study consists of 2 visits and your participation consists of:
   1. Screening exam with sensitivity measures
   2. One blood sample and dietary measures
3. Compensation: up to $210, receive a free picture of your brain and free parking during the study visits.

If interested, please call (310) 825-5255 or check out our website at: http://www.uclacns.org
Protocol ID: IRB #13-001113 UCLA IRB Approval Date: 3/10/2016 through: 3/9/2017 Committee: Medical IRB 3

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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: $100 per visit (except screening), receive a free picture of your brain and free parking during the study visits. This is a 12 month study.

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: 10/9/2015 through 8/10/2017 Committee: Medical IRB 3

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The Effect of Cranial Electrotherapy Stimulation on Emotional and Cellular Wellbeing in Veterans

Are you interested in a non-invasive, non-drug therapy for mood symptoms? The purpose of this study is to learn more about anxiety and/or depression and is conducted by Dr. Kirsten Tillisch at the G. Oppenheimer Center for Neurobiology of Stress and Resilience.

1. We are looking for OIF/OEF male Veterans between the ages of 18-40 and suffer from anxiety and/or depression
2. The treatment is a safe, commercially available take-home electrotherapy device. It delivers a low-level current via ear clips. This is a randomized, controlled trial, so half of the participants will have active devices and half will have inactive devices.
3. Involvement includes a screening visit and two clinic visits, one blood draw during the first and last visit, and the completion of questionnaires, which will take place at UCLA.
4. Compensated up to $200 for study completion.

If interested, please call (310) 206-8545.

Protocol ID:IRB#15-001639 UCLA IRB Approved Approval Date: 2/19/2016 through 2/10/2017 Committee: Medical IRB 3

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Endoscopic Ultrasound Guided Rendezvous vs Advanced ERCP Techniques for Biliary Access

If you are a male or female 18 years old referred for endoscopic retrograde cholangiopancreatography (ERCP), you may be eligible to participate in this research study. The study will evaluate the efficacy of different endoscopic techniques that may help cannulate the bile duct during ERCP. We aim at defining the best endoscopic method that should be utilized for patients that are difficult to cannulate during ERCP.

Inclusion/Exclusion Criteria:

1. Study participants must be at least 18 years old referred for ERCP as a part of his/her clinical management.
2. Study participant must be diagnosed with a difficult-to-cannulate bile duct during ERCP (inability to cannulate the bile ducts within 10 minutes of the start of ERCP).
3. Study participant must not have any bleeding disorder.
4. Study participant must not have pancreatic or biliary stent placement within 6 months of time of enrollment.
5. Pregnant and breast-feeding ladies are ineligible to participate.
6. Certain patients with surgically altered biliary anatomy or certain prior endoscopic interventions are ineligible to participate (Call for details).

This study is conducted by Dr. V. Raman Muthusamy. The study is coordinated by Amanda Moralde.
If interested, please call (310) 267-3636.
Protocol ID: IRB# 14-001221

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Using a Mobile Phone Application for Colonoscopy Bowel Preparation: A Feasibility Study

If you are a male or female >50 years old undergoing screening colonoscopy and have a Smartphone that you are able to operate, you may be eligible to participate in this research study. The study will evaluate the utility of a mobile application to help patients prepare for their anticipated colonoscopy. We hope that the application will be a useful tool that allow the patients to best prepare for their colonoscopy.

Inclusion/Exclusion Criteria:

• Study participants must be at least 50 years old.
• Study participant must be undergoing screening colonoscopy as a part of their clinical management.
• Study participant must have a Smartphone and be able to handle it well.
• Study participant must not have any past history of colon cancer and must not have any family history of colon cancer.
• Patients who have been diagnosed with inflammatory bowel disease (IBD) are ineligible.

This study is conducted by Dr. V. Raman Muthusamy. The study is coordinated by Amanda Moralde.
If interested, please call (310) 267-3636.
Protocol ID: IRB# 14-001519

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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 310-206-9232 or DOMIBD@mednet.ucla.edu

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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 completion date is March 22, 2017. ClinicalTrials.gov identifier is NCT02348814.

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Randomized Controlled Trial of Endoscopic Dilation with or without Triamcinolone Injection in Patients with Non-malignant Radiation or Anastomotic Esophageal Strictures

If you are a male or female >18 years old presented for an upper endoscopy with difficulty of swallowing (dysphagia) following radiation exposure or anastomotic surgery, you may be eligible to participate in this research study. The study will compare the response of endoscopic dilation alone, compared to endoscopic dilation combined with corticosteroid (Triamcinolone) injection. We aim at defining the best therapeutic option for each subset of patients.

Inclusion/Exclusion Criteria:

1. Patients undergoing an upper endoscopy with dilation for dysphagia symptoms thought secondary to either radiation-induced stricture or anastomotic esophageal stricture.
2. Study participants must be at least 18 years old.
3. Study participants must not have active candida esophagitis, uncontrolled hypertension or active or latent tuberculosis or any history of tuberculosis.
4. Pregnant ladies are ineligible to participate.

This study is conducted by Dr. V. Raman Muthusamy. The study is coordinated by Amanda Moralde.
If interested, please call (310) 267-3636.
Protocol ID: IRB# 14-001164

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Clinical Feasibility and Efficacy of a New Digital Single-operator Per-oral Cholangiopancreatioscopy System: A Multicenter Registry

Cholangioscopy is an endoscopic technique used for direct visualization of the bile ducts. The new FDA approved digital Spyglass system introduced a digital sensor for better image quality, which will allow for better visualization and diagnosis. If you are a male or female >18 years old referred for the evaluation of biliary strictures (narrowing) or removal of difficult stones, you might be eligible to participate in the study. You must be undergoing ERCP along with DS Spyglass cholangioscopy as part of your clinical care at UCLA. The study will evaluate the clinical safety, feasibility and efficacy of the new Spyglass DS Spyglass cholangioscopy system for diagnostic imaging of biliary tract disorders (particularly those with biliary strictures and stones).

Inclusion/Exclusion Criteria:

1. Patients who are 18 years or older that are referred for the evaluation of indeterminate strictures or removal of difficult stones are eligible to participate.
2. Patients who are unable or unwilling to give consent will not be included in the study.

This study is conducted by Dr. V. Raman Muthusamy. The study is coordinated by Amanda Moralde.
If interested, please call (310) 267-3636.
Protocol ID: IRB# 16-000341

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Assessment of a Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett's Esophagus or GERD Symptoms

If you are a male or female >18 years old with a previously confirmed diagnosis of Barrett's esophagus (BE) with intestinal metaplasia or gastroesophageal reflux disease (GERD) symptoms occurring at least once a month for 6 consecutive months, you might be eligible for the study. The study will evaluate a newly-developed minimally invasive cytology collection system (Cytosponge) in the diagnosis of BE. We hope to develop and validate a new minimally-invasive, reliable, diagnostic method that will possibly replace endoscopy as the method used to screen for BE.
 
Inclusion/Exclusion Criteria:

1. Study participants must be 18 years or older with previous confirmed diagnosis of BE with intestinal metaplasia in last 3 years (BE arm) or with heartburn or regurgitation on at least a monthly basis for at least 6 months (GERD arm). Study participants have to be in need for upper endoscopy as part of your management.
2. Study participants cannot have been diagnosed with an oropharyngeal, esophageal or gastro-esophageal tumor.
3. In addition, study participants may not have ongoing symptoms of dysphagia, the presence of esophageal varices, or an active stricture. Participants cannot have undergone any previous esophageal surgery, except for uncomplicated fundoplication.
4. Participants may not have a known bleeding disorder.
5. Patients who have had a myocardial infarction or any cardiac event 6 months or less prior to enrollment or those who have had a cerebrovascular event 6 months or less prior to enrollment in which swallowing was affected are ineligible to participate.
6. Study participants must not have undergone prior ablative or resection therapy of the esophagus nor have any planned ablation therapy within 3 days after Cytosponge administration.

This study is conducted by Dr. V. Raman Muthusamy. The study is coordinated by Amanda Moralde.
If interested or in case you have any inquiries, please call (310) 267-3636.
Protocol ID: IRB# 15-000626

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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 view UCLA Asian Liver Program clinical trials >