Chronic Diarrhea Clinical Trial
Official title:
Secondary Lactose Intolerance Due to Chronic Norovirus Infection in Renal Transplant Recipients
Verified date | December 2015 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 15 |
Est. completion date | December 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich, Division of Internal Medicine | Zurich | ZH |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lactose intolerance | Prevalence of lactose intolerance stated with a positive LH2BT and/or a positive LTT in RTRs with chronic norovirus infection. | 4 weeks | No |
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