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Performance of 13C Mannitol for in Vivo Measurement of Small Intestinal Permeability

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ClinicalTrials.gov Identifier: NCT02603822
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Madhusudan (Madhu) Grover, MBBS, Mayo Clinic

Brief Summary:
The investigators' overall objective with this study is to determine performance characteristics of small intestine permeability measurement using 13C mannitol and 12C (regular) mannitol.

Condition or disease Intervention/treatment Phase
Impaired Small Intestinal Permeability Dietary Supplement: 12C mannitol Drug: Indomethacin Dietary Supplement: 13C mannitol Dietary Supplement: Lactulose Phase 1

Detailed Description:

An impaired intestinal permeability is implicated in the pathophysiology of a number of disorders such as celiac disease, environmental enteropathy, inflammatory bowel disease, obesity, and HIV. Current measurements of intestinal permeability rely on urinary excretion of naturally available, orally ingested, non-absorbable sugars (e.g. lactulose, mannitol). However, dietary intake of these sugars limits interpretation from these assays.

Subjects will have an esophagogastroduodenoscopy (EGD) with biopsies and provide a baseline urine sample. They will be asked to ingest 3 saccharides (12C mannitol 100 mg,13C mannitol 100 mg and lactulose 1 g) in 250 ml of water. Urine samples will be obtained every 30 min. in the Clinical Research and Trials Unit (CRTU) for 0-2 hours. Subjects will collect 2-8 hour sample in provided container. Another container will be provided to collect the 8-24 hour urine which will be returned the following morning. Subjects will undergo an Indomethacin challenge intervention. They will be instructed to take three 25 mg capsules 8 hours before their next visit (just before fasting). They will take 3 additional 25 mg capsules 30 min. before the repeat in vivo permeability testing. Repeat EGD with duodenal biopsies will be done. Long term follow-up will be done within 4-6 weeks of previous testing, where subjects will once again be asked to complete the in vivo permeability testing.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Basic Science
Official Title: Performance of 13C Mannitol for in Vivo Measurement of Small Intestinal Permeability
Study Start Date : August 2015
Actual Primary Completion Date : July 17, 2018
Actual Study Completion Date : July 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy Volunteers
Subjects will receive a saccharide solution of 12C mannitol 100 mg, 13C mannitol 100 mg, and lactulose 1 g in 250ml of water at visits 2, 5, and 7 prior to permeability testing. The subjects will also receive Indomethacin capsules prior to visit 5.
Dietary Supplement: 12C mannitol
12C mannitol 100 mg

Drug: Indomethacin
Subjects will receive six 25 mg capsules of Indomethacin (immediate release). The subjects will take 3 capsules 8 hours before the timing of visit 5 (before fasting), and 3 additional capsules 30 minutes before visit 5.
Other Name: Indocin

Dietary Supplement: 13C mannitol
13C mannitol 100 mg

Dietary Supplement: Lactulose
lactulose 1 g




Primary Outcome Measures :
  1. Small intestine permeability as measured by change in cumulative excretion of mannitol 0-2 hours [ Time Frame: baseline, approximately 2 hours ]

Secondary Outcome Measures :
  1. Colonic permeability as measured by change in mannitol excretion between 8 and 24 hours [ Time Frame: 8 hours, approximately 24 hours ]
  2. Change in mannitol excretion at 24 hours [ Time Frame: baseline, approximately 24 hours ]
  3. Change in lactulose-mannitol excretion assay at 2 hours [ Time Frame: baseline, approximately 2 hours ]
    The ratio of urinary excretion of lactulose to mannitol was used to measure intestinal mucosal permeability, with higher ratios indicative of increased intestinal permeability.

  4. Change in hour lactulose-mannitol excretion assay between 8 and 24 hours [ Time Frame: 8 hours, approximately 24 hours ]
    The ratio of urinary excretion of lactulose to mannitol was used to measure intestinal mucosal permeability, with higher ratios indicative of increased intestinal permeability.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Healthy Volunteers

Inclusion criteria:

  • Age (yr) 18 to 65
  • No abdominal surgery (except appendectomy and cholecystectomy, others may be considered)

Exclusion criteria:

  • History of irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease.
  • Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
  • Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin within seven days of first permeability test (as NSAIDs affect intestinal permeability) and second permeability test (except those administered for the study)
  • Use of oral corticosteroids within the previous 6 weeks
  • Ingestion of artificial sweeteners such as Splenda® (sucralose), NutraSweet® (aspartame), lactulose or mannitol within two (2) days of each permeability test and endoscopy procedure date, e.g., foods to be avoided are sugarless gums or mints and diet soda
  • Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit within 7 days each permeability test and endoscopy procedure date. This includes drugs such as serotonin (5-HT) agents, narcotics, anticholinergics, anti-nausea medications, any medications for diarrhea or constipation.
  • Antibiotics within 7 days each permeability test and endoscopy procedure date
  • Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
  • Score > 8 for anxiety or depression on Hospital Anxiety and Depression scale.
  • Pregnancy

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): NCT02603822


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Madhusudan Grover, MBBS Mayo Clinic
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Responsible Party: Madhusudan (Madhu) Grover, MBBS, Madhusudan Grover, MBBS, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02603822    
Other Study ID Numbers: 15-003603
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Indomethacin
Mannitol
Lactulose
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents