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Secondary Lactose Intolerance Due to Chronic Norovirus Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01840891
First Posted: April 26, 2013
Last Update Posted: December 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  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: None (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 ]
    Prevalence of lactose intolerance stated with a positive LH2BT and/or a positive LTT in RTRs with chronic norovirus infection.


Enrollment: 15
Study Start Date: April 2013
Study Completion Date: December 2015
Primary Completion Date: September 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840891


Locations
Switzerland
University Hospital Zurich, Division of Internal Medicine
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

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01840891     History of Changes
Other Study ID Numbers: NORO2013
First Submitted: April 11, 2013
First Posted: April 26, 2013
Last Update Posted: December 18, 2015
Last Verified: December 2015

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


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