Trials Sponsors Conditions Drugs Pricing

Conditions

Impaired Small Intestinal Permeability

Outcome Measures

Primary Outcomes (1)

Small intestine permeability as measured by change in cumulative excretion of mannitol 0-2 hours
baseline, approximately 2 hours

Secondary Outcomes (4)

Colonic permeability as measured by change in mannitol excretion between 8 and 24 hours
8 hours, approximately 24 hours
Change in mannitol excretion at 24 hours
baseline, approximately 24 hours
Change in lactulose-mannitol excretion assay at 2 hours
baseline, approximately 2 hours
Change in hour lactulose-mannitol excretion assay between 8 and 24 hours
8 hours, approximately 24 hours

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

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 mannitolDrug: IndomethacinDietary Supplement: 13C mannitolDietary Supplement: Lactulose

Interventions

12C mannitolDietary supplement

12C mannitol 100 mg

Healthy Volunteers

IndomethacinDrug

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.

Also known as: Indocin

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Mayo Clinic
Otherlead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

MeSH Terms

Interventions

IndomethacinLactulose

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

Madhusudan Grover, MBBS
Mayo Clinic
PRINCIPAL INVESTIGATOR

Enrollment

25 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Masking Details: Open Label
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Madhusudan Grover, MBBS

Study Record Dates

First Submitted

September 22, 2015

First Posted

November 13, 2015

Study Start

August 2015

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Healthy Volunteers

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Healthy Volunteers

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations