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Trial record 3 of 16 for:    "Hepatitis, Autoimmune"

The Role of Sodium Chloride and the Treg/Th17 Axis in Autoimmune Hepatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02050646
First received: November 4, 2013
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine whether a salt restriction diet improves immune parameters in patients with autoimmune hepatitis.


Condition Intervention
Autoimmune Hepatitis
Other: Low Salt Diet
Other: Liberal salt diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: The Role of Sodium Chloride and the Treg/Th17 Axis in Autoimmune Hepatitis

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change from baseline in production of pathogenic TH17 cells. [ Time Frame: 26 days ] [ Designated as safety issue: No ]
    Measuring TH17 cells by flow cytometry and qRT-PCR. There are no known normal ranges. The investigator will calculate the change by observing the difference from baseline values.


Secondary Outcome Measures:
  • Change from baseline in regulatory T cell function. [ Time Frame: 26 days ] [ Designated as safety issue: No ]
    Measuring T cell function by flow cytometry. There are no known normal ranges. The investigator will calculate the change by observing the difference from baseline values.


Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low salt/ Liberal salt Diet
Cross-over trial of liberal salt and low salt diet.
Other: Low Salt Diet
On Day 0, patients will be randomized to one of the two crossover liberal/low or low/liberal salt diet groups. Each subject will complete two controlled dietary phases: 10-days of low salt diet, a washout period of 3-days, and 10-days of liberal salt diet.
Other: Liberal salt diet
On Day 0, patients will be randomized to one of the two crossover liberal/low or low/liberal salt diet groups. Each subject will complete two controlled dietary phases: 10-days of low salt diet, a washout period of 3-days, and 10-days of liberal salt diet.
Experimental: Liberal salt/Low salt diet
Cross-over trial of low salt and liberal salt diet
Other: Low Salt Diet
On Day 0, patients will be randomized to one of the two crossover liberal/low or low/liberal salt diet groups. Each subject will complete two controlled dietary phases: 10-days of low salt diet, a washout period of 3-days, and 10-days of liberal salt diet.
Other: Liberal salt diet
On Day 0, patients will be randomized to one of the two crossover liberal/low or low/liberal salt diet groups. Each subject will complete two controlled dietary phases: 10-days of low salt diet, a washout period of 3-days, and 10-days of liberal salt diet.

Detailed Description:

The etiology of autoimmune hepatitis (AIH) is unknown although both genetic and environmental factors are thought to be involved. A defect in immune regulation affecting regulatory T cells (Tregs) has been demonstrated in AIH. Tregs function in the maintenance of immune homeostasis by controlling autoreactive immune responses to self-antigens.

Rationale: the western diet has been postulated as a potential environmental risk factor for the increasing incidence of autoimmune diseases in developed countries. Data from the investigators' laboratory also suggests that increased dietary salt intake might represent an environmental risk factor for the development of autoimmune diseases through the induction of pathogenic Th17 cells. The dramatic in vitro effects of high salt on the induction of pathogenic Th17 cells from naïve human CD4 cells {Kleinewietfeld, Hafler. Nature. 2013 Apr 25;496(7446):518-22. doi: 10.1038/nature11868.}, and block of in vitro Treg suppression, in line with in vivo effects on worsening murine experimental autoimmune encephalomyelitis (EAE), have prompted the investigators to examine the effects of increased dietary sodium chloride in a human in vivo system.

The investigators hypothesize that excess dietary salt may function as an environmental trigger that favors induction and expansion of pathogenic Th17 cells and leads to functional impairment of Tregs, thereby favoring development of autoimmunity. The investigators aim to study their established in vitro model in humans by altering the salt intake in patients over a 20-day period.

  Eligibility

Ages Eligible for Study:   10 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18-50 years of age
  • Children 10-17 years of age
  • ALT and/or ALP/GGT level > 2X upper limit of normal
  • ANA or SMA >/= 1:40
  • ANA or SMA >/= 1:80
  • or LKM >/= 1:40
  • or SLA positive
  • IgG > upper limit of normal

Exclusion Criteria:

  • Chronic hepatitis C
  • Decompensated Liver Disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050646

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Udeme Ekong, MD, MPH    203-785-4649    udeme.ekong@yale.edu   
Contact: Lisa Nichols, BA    203-785-7526    lisa.nichols@yale.edu   
Principal Investigator: Udeme Ekong, MD, MPH         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Udeme Ekong, MD, MPH Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02050646     History of Changes
Other Study ID Numbers: 1303011696, YSOM Pediatrics Department
Study First Received: November 4, 2013
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Autoimmune hepatitis
Liver dysfunction
Elevated serum auto antibodies

Additional relevant MeSH terms:
Hepatitis, Autoimmune
Hepatitis
Hepatitis A
Autoimmune Diseases
Digestive System Diseases
Enterovirus Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Immune System Diseases
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014