Active Clinical Trials

Colonoscopy Preparation Study

Contact Dr. Jeannie S. Huang at 858-966-4003 or jshuang@ucsd.edu.

The study will evaluate the efficacy, safety and tolerability of a colonoscopy bowel preparation in children 9-16 years of age. Study volunteers must have bowel movements at least three times a week and require a bowel preparation for a colonoscopy.

Enrolled participants will receive either Prepopik or the standard bowel preparation.

Eosinophilic Esophagitis

Contact Dr. Hayat Mousa at hmousa@rchsd.org or Dr. Maheen Hassan at mhassan@rchsd.org.

Esophageal Distensibility as a Predictor of Fibrotic Remodeling and Clinical Phenotype in Pediatric Patients with Eosinophilic Esophagitis

The study will focus on patients with symptoms of eosinophilic esophagitis, an allergy-related disease characterized by eosinophilic inflammation of the esophagus. Symptoms may include, but not be restricted to, food impaction, dysphagia, feeding intolerance, and reflux. The primary aims are to determine if there is a difference in the esophageal distensibility in pediatric patients with eosinophilic esophagitis and to determine the predictability of symptoms in the pediatric age group.

Inclusion criteria:

  • Patients ages 8-18 years old
  • Symptomatic patients (dysphagia, food impaction, GERD, nausea/vomiting, and/or chest pain)
  • Patients with established eosinophilic esophagitis

Liver Disease

Contact Janis Durelle, clinical research manager, at 619-543-5226 or jdurelle@ucsd.edu.

NASH Clinical Research Network (CRN) Database 2 Study

This study aims to elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular, it’s more severe form of NASH and its complications. The study will add to the existing NAFLD Database an additional 650 pediatric participants with a diagnosis of NAFLD, supported by a recent liver biopsy, with a broad range of severity. Core data collection will include clinical, demographic, laboratory, imaging, and histological features.

The study consists of a screening visit and annual follow-up visits for up to 10 years. Procedures that will be completed at each of the visits are: medical history and other related questionnaires, physical examination, vital signs and measurement, laboratory data from medical chart or research visit, and blood collection.

In order to be enrolled in the Database 2 study, pediatric patients must satisfy all of the following:

  • Alcohol use history consistent with NAFLD
  • Imaging study suggestive of NAFLD or biopsy materials meeting histologic definition of NAFLD or
    cryptogenic cirrhosis (histology must be confirmed by local NASH CRN pathologist) or imaging study and clinical findings meeting the criteria for suspected (clinical) cryptogenic cirrhosis
  • Ability and willingness of patient or legal guardian/parent to give written, informed consent
  • Patient assent for those over 8 years old
  • Age of at least 2 years old and less than 18 years old at initial screening visit
  • Ability and willingness to participate in follow-up visits

Dietary Treatment Study of Pediatric NAFLD

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in children and adults in the United States and is estimated to effect up to 20 million Americans. The cause of NAFLD is not yet well-defined but represents a complex, multifactorial disorder influenced by the interaction of genes and environmental factors and is closely associate with the metabolic syndrome. Because of the high level of consumption and its metabolic fate, fructose has been studied in relation to many health problems, including NAFLD.

This is an investigator initiated study being conducted in equal numbers at two sites, UC San Diego and Emory University. UCSD will also serve as the Radiology Coordinating site. The study aim will be evaluated in an eight-week randomized, controlled, outpatient feeding study. Participants will be boys age 11-16 years with a history of NAFLD. Participants will be randomized to the intervention arm or the observational arm. The intervention group will be provided with food for eight weeks by a research dietitian in order to emulate their habitual diet revised to a diet with low free sugar content (<3% of total daily calories). The control group will continue their habitual diet.

There will be 20 children in each group across the study. Thus at UCSD, there will be 10 children in the intervention group and 10 children in the control group. All particpants will have a minimal risk evaluation to include standard clinical labs and a non-contrast MRI of the liver. The primary outcome will be the change in liver fat from baseline to week eight.

The primary outcome measure is to evaluate change in liver fat over eight weeks in response to a low- sugar diet in children with NAFLD.

The Intestinal Bacterial Metagenome in Pediatric NAFLD

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in children.  NAFLD is most common in overweight children. Some children with NAFLD have a progressive form known as nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis or liver cancer. Information explaining why some overweight children get liver disease and some do not is limited. Also, there are many unknowns regarding what determines the severity of the liver disease.

We believe that the collection of organisms inhabiting the intestinal tract (intestinal microbiome) influence human nutrition, metabolism, and inflammation. As such, these organisms may determine which children get liver disease and how severe the liver disease will be. We will therefore study children with and without liver disease. We will evaluate their overall health, their liver status, and carefully evaluate their intestinal microbiome using the latest genetic technologies. Greater understanding of the role of the intestinal microbiome in the development and progression of NAFLD in children could lead to improvements in prevention, diagnosis and treatment.

To investigate the role of the intestinal microbiome in the development and progression of NAFLD, we intend to characterize the microbiome in obese children with and without NAFLD and determine the relationship between alterations in the intestinal microbiome, immune activation, and the progression of NAFLD.

Motility

Contact Dr. Hayat Mousa at hmousa@rchsd.org.

Study # 1: Electrophysiology of the Gut and the Microbiome in High-Risk Neonates

Epidermal electronics system (EES) is a very slim, comfortably worn non-invasive device used to record electrophysiological activity. Previous studies on normal adults indicate the ability of EES to detect features of gastrointestinal motility. The current study will determine the effective use of EES to record the electrophysiology of the digestive system and validate the technique is predictive of motility in high-risk neonates.

Inclusion criteria:

  • Neonates of any ethic background, medical history, and gender
  • Scheduled to undergo antroduodenal manometry

Study # 2: Defining Abnormalities in the Enteric Nervous System (ENS) of Children with Gastrointestinal Motility Disorders 

The enteric nervous system (ENS) provides local control of the gastrointestinal tract and is necessary for the coordination of functions of multiple cellular components that make up the gut wall. Recent interest in the role of glial cells, found at multiple levels through the gut wall along the length of the gastrointestinal tract, has prompted a growing interest in the hypothesis that these cells actively participate in gut motility. Currently, it is unknown how these cells influence enteric neurotransmission.

The study will use tissue/specimens of individuals with gastrointestinal motility disorders to focus on the pathophysiology of GI motility disorders in children. It will provide information to identify normal and age-specific controls to determine morphologic changes on a cellular/molecular level.

Gastrointestinal motility disorders include:

  • Pseudoobstruction
  • Hirschsprung’s disease
  • Allied Hirschspurng’s disease
  • Congenital intestinal atresia (and other congenitally dysmorphic gut)
  • Gastroparesis
  • Colonic inertia
  • Constipation
  • Post-infectious neuropathic disorders
  • Irritable bowel syndrome
  • All other motility and functional GI disorders

Study #3: 2’-Fucosyllactose and Gut Motility in Human Subjects

2’-Fucosyllactose has been associated with a lowering the incidence of moderate to severe cases of diarrhea in infants. Using antroduodenal manometry and fluoroscopy to measure the contractions of the stomach and small intestine, the current study will determine if direct administration of 2’FL to the lining of the intestine will cause a reduction in the migrating motor complexes of the small intestinal tract.

Inclusion Criteria:

  • Subjects undergoing antroduodenal manometry
  • Between the ages of 12-18

Study #4: A Validation Study of Passive, Skin-mounted Electrodes to Monitor the Electrical Activity of the Human Digestive System in Children

The study will use a non-invasive electrophysiology monitoring technique developed for adults to determine if it is predictive of motility in children, if the motor response to provocative testing is reflected in the electrophysiology, and if there is a clinical phenotype associated with electrophysiological abnormalities.

Weight Management

Call 855-UCSD-4-W8 (855-827-3498)​ or email chear@ucsd.edu.

FRESH-DOSE (Family, Responsibility, Education, Support, Health—Dual Options for Sustained Effectiveness)

Ages: 7-12

The Family, Responsibility, Education, Support, Health—Dual Options for Sustained Effectiveness (FRESH—DOSE) study is a six-month treatment program for children aged 7-12  and their parents. Families must be willing to participate in individual or group treatment programs. No medication or medical procedures are involved. There is no cost to participants, and families are compensated for time and effort. The study’s duration is up to two years.

ReFRESH (Reinforced Enhanced Family, Responsibility, Education, Support & Health)

Ages: 7-12

The Reinforced Enhanced Family, Responsibility, Education, Support & Health study is a program for children ages 7-12 and their parents. The treatment program is six months and focuses on weight loss, healthy eating strategies and skills for effective parenting and behavior management. Families also attend assessment appointments and will be compensated for their time and effort. The study’s duration is up to two years.

GOTDoc

Ages: 5-12

GOTDoc is a six-month program providing family-based behavioral therapy for children ages 5-12 who are overweight or obese. Families who are patients at Children’s Primary Care Medical Group in Chula Vista or Escondido can be enrolled in this study by asking their primary care physicians to send a referral to CHEAR.