Trial record 3 of 5 for:    Open Studies | "Norovirus"

Secondary Lactose Intolerance Due to Chronic Norovirus Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01840891
First received: April 11, 2013
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

The objective of this study is to determine the prevalence of secondary lactose intolerance in renal transplant recipients (RTR) with chronic norovirus infection.

In the investigators cohort of 1000 renal transplant recipients (RTRs) in the University Hospital of Zurich, the investigators are currently aware of 10 patients with chronic norovirus infection, which was proven by positive polymerase chain reaction (PCR) analysis of recent stool samples, whereas chronic virus shedding is defined as more than two PCR positive samples in an interval of at least one month. Concomitant viral (other than norovirus), bacterial or parasitic (particularly Gardia lamblia) intestinal infections are excluded by negative stool cultures and PCR analyses, respectively. Main exclusion criterion for the present case series is a concomitant intestinal infection (other than norovirus) and primary lactose intolerance, which is previously excluded by absence of the CC genotype of the DNA variant -13910 T/C upstream in the LCT gene. After obtaining written and oral informed consent, the investigators perform a lactose hydrogen breath (LH2BT) test and a lactose tolerance test (LTT) in all eligible RTRs with proven chronic norovirus infection irrespective of current abdominal symptoms.

The study population (N=10) is divided into two groups according to the gastrointestinal symptoms (asymptomatic versus symptomatic, such as chronic diarrhoea or diffuse abdominal discomfort). The investigators chose the cut-off three or more stools per day as indicative of diarrhoea for the purpose of this study. RTRs with otherwise unexplainable chronic diarrhoea but absent norovirus infection serve as control group (N=10).


Condition Intervention
Chronic Diarrhea
Behavioral: Lactose H2 breath test (LH2BT)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Secondary Lactose Intolerance Due to Chronic Norovirus Infection in Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Lactose intolerance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Prevalence of lactose intolerance stated with a positive LH2BT and/or a positive LTT in RTRs with chronic norovirus infection.


Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Noro virus shedder
Lactose H2 breath test (LH2BT)
Behavioral: Lactose H2 breath test (LH2BT)
Prevalence of lactose intolerance stated with a positive LH2BT and/or a positive LTT in RTRs with chronic norovirus infection.
Other Name: A-AlveoSamplerTM (Quintron Instrument Co., WI, USA)
Active Comparator: No norovirus shedding
Lactose H2 breath test (LH2BT)
Behavioral: Lactose H2 breath test (LH2BT)
Prevalence of lactose intolerance stated with a positive LH2BT and/or a positive LTT in RTRs with chronic norovirus infection.
Other Name: A-AlveoSamplerTM (Quintron Instrument Co., WI, USA)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

- Renal transplant recipient (RTR) with proven diagnosis of chronic norovirus infection, whereas chronic virus shedding is defined as more than two polymerase chain reaction (PCR) positive samples in an interval of at least one month (case group) or chronic diarrhoea defined as more than three bowel movements per day since more than four weeks (control group).

Exclusion criteria:

  • Missing informed consent.
  • Primary lactose intolerance.
  • Concomitant intestinal infection (other than norovirus).
  • Subjects with galactosemia or patients requiring a low galactose diet.
  • Age < 18 years.
  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: NCT01840891

Contacts
Contact: Daniel Franzen, MD daniel.franzen@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Internal Medicine Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Daniel Franzen, MD University Hospital Zurich, Division of Internal Medicine
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01840891     History of Changes
Other Study ID Numbers: NORO2013
Study First Received: April 11, 2013
Last Updated: May 26, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Lactose Intolerance
Carbohydrate Metabolism, Inborn Errors
Digestive System Diseases
Gastrointestinal Diseases
Genetic Diseases, Inborn
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases
Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on October 23, 2014