Secondary Lactose Intolerance Due to Chronic Norovirus Infection

NCT01840891 | Completed DMC

• 1 other identifier: NORO2013
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Diarrhea

Outcome Measures

Primary Outcomes (1)

• Lactose intolerance

  Prevalence of lactose intolerance stated with a positive LH2BT and/or a positive LTT in RTRs with chronic norovirus infection.

  4 weeks

Study Arms (2)

Noro virus shedder

EXPERIMENTAL

Lactose H2 breath test (LH2BT)

Behavioral: Lactose H2 breath test (LH2BT)

No norovirus shedding

ACTIVE COMPARATOR

Lactose H2 breath test (LH2BT)

Behavioral: Lactose H2 breath test (LH2BT)

Interventions

Lactose H2 breath test (LH2BT) BEHAVIORAL

Prevalence of lactose intolerance stated with a positive LH2BT and/or a positive LTT in RTRs with chronic norovirus infection.

Also known as: A-AlveoSamplerTM (Quintron Instrument Co., WI, USA)

No norovirus shedding; Noro virus shedder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Division of Internal Medicine

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• Bonani M, Pereira RM, Misselwitz B, Fehr T, Wuthrich RP, Franzen D. Chronic Norovirus Infection as a Risk Factor for Secondary Lactose Maldigestion in Renal Transplant Recipients: A Prospective Parallel Cohort Pilot Study. Transplantation. 2017 Jun;101(6):1455-1460. doi: 10.1097/TP.0000000000001376.

  PMID: 27482964 DERIVED

Study Officials

• Daniel Franzen, MD

  University Hospital Zurich, Division of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 26, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

CH (1)