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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|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|
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
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
- Small intestine permeability as measured by change in cumulative excretion of mannitol 0-2 hours [ Time Frame: baseline, approximately 2 hours ]
- Colonic permeability as measured by change in mannitol excretion between 8 and 24 hours [ Time Frame: 8 hours, approximately 24 hours ]
- Change in mannitol excretion at 24 hours [ Time Frame: baseline, approximately 24 hours ]
- 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.
- 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.
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
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Madhusudan Grover, MBBS||Mayo Clinic|