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The Effect of L-lysine on Human Gastrointestinal Secretion: A Dose-finding Study Applying Magnetic Resonance Imaging (MRI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01579799
First received: April 16, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

This is a pilot dose-finding study, which is performed with a randomized, double-blind, 3-armed, unbalanced, cross-over study design. Three of four different doses of L-lysine Monohydrate (A = 0.5 g, B = 1.2 g, C = 3.0 g and D = 7.5 g) will be applied in a randomized sequence on three different study days in six healthy volunteers. Each study day involves the repeated measurement of gastric content volume, gastric secretion volume and intestinal fluid volume using MRI before and after intragastric infusion of L-lysine Monohydrate test meals. Additionally, symptoms for hunger, fullness, nausea, bloating, abdominal cramps and urge to defecate will be recorded using a scale from 0-10. In parallel, samples of gastric juice to measure intragastric pH and pepsin concentration, samples of venous blood to assess blood pH and haematocrit as well as L-lysine, Serotonin, chloride bicarbonate and albumin plasma concentration and samples of arterialized blood from ear lobe to measure glucose blood concentration will be collected


Condition Intervention
Healthy
Drug: L-lysine

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Enrollment: 6
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: L-lysine
    Dose finding study for L-lysine
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

healthy volunteers

Criteria

Inclusion criteria: > 18, < 50 years Healthy BMI > 19, <24

Exclusion criteria: Age under 18 or above 50

  • Pathologic underweight or overweight (BMI <19 or >24 (kg/m2))
  • Previous gastrointestinal, cardio-respiratory (incl. arterial hypertension), hematologic (anaemia), renal, hepatic, atopic, alimentary disease, psychiatric disease, epilepsy, panic attacks, diabetes drug or alcohol abuse, lysinuria, galactosaemia
  • Subjects unable to stop medication that alters gut function for 1 week prior to the study, including anticholinergics, calcium canal inhibitors, beta blocker, prokinetics, proton-pump inhibitors, DDV-IV-Inhibitors, Incretin-mimetics, non-steroidal anti-inflammatory drugs, Macrolidantibiotica
  • Subjects unable to stop medication within 48 prior the study begins that alters serotonin blood profiles , including paracetamol, cumarine, mephenesin, phenobarbital, acetanilide, ephedrine, amphetamine, phentolamin, phenacetin, methocarbamol, acetylsalicylic acid, levodopa, promethazine, isoniazid, methenamine, streptozocin, chlorpromazine
  • Positive helicobacter pylori test
  • Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders)
  • Presence of metallic implants, devices or metallic foreign bodies
  • Pregnancy and lactation (female patients of child bearing age will receive a pregnancy test prior to study)
  • Involvement in any other clinical trial during the course of this trial, nor within a period of 14 days prior to its beginning or 14 days after its completion
  • Mental capacity (DSM IV, inter alia Claustrophobia), which limits the capability to fulfill the demands of the study
  • Known allergy or intolerance against capsaicin, locus bean gum, L-lysine, DOTAREM®, Fructose, Gluten, Galactose Known allergic reaction after prior injection of lidocaine (e.g. at the dentist )
  • Known allergic reaction toward methylparaben (E218)
  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: NCT01579799

Locations
Switzerland
University Hospital Zurich, Gastroenterology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Werner Schwizer, Prof. MD University Hospital Zurich, Gastroenterology & Hepatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01579799     History of Changes
Other Study ID Numbers: KEK-ZH-NR. 2012-0005
Study First Received: April 16, 2012
Last Updated: September 11, 2012
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on November 20, 2014