Active Clinical Trials

Child Learn Study

We are looking for healthy-weight children between the ages of 8-11 with two overweight or two healthy weight parents to participate in a two-year study. Children and their parents will be asked to complete some interviews and computer tasks. Children will also be asked to complete a one-time, 90-minute brain scan session (functional magnetic resonance imaging (fMRI)). The fMRI scan is only for the children and does not involve any radiation. No medication is involved in the study.  There is no cost to participants, and families are compensated for time and effort. The entire study includes a total of seven visits over two years (three baseline visits, two visits one year after and two visits at the end of the second year).

Eligibility Information

The child must:

  • Be age 8-11 with a participating parent/guardian
  • Be age- and gender-adjusted BMI percentile (BMI%) 30th to 75th percentile
  • Be right-handed
  • Have a parent/guardian willing to drive to La Jolla for assessments and the brain imaging session for the duration of the study
  • Have two biological parents who are both overweight (BMI>25) or both healthy weight (18<BMI<25) with one current parent willing to participate

For more information, please call toll-free at 1-855-UCSD-4-W8 (1-855-827-3498) or email chear@ucsd.edu.
IRB#161468

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

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.