NCT02603822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2018

Completed
Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

3 years

First QC Date

September 22, 2015

Last Update Submit

June 3, 2019

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
Healthy Volunteers
13C mannitolDIETARY_SUPPLEMENT

13C mannitol 100 mg

Healthy Volunteers
LactuloseDIETARY_SUPPLEMENT

lactulose 1 g

Healthy Volunteers

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:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

IndomethacinLactulose

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Madhusudan Grover, MBBS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

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 1, 2015

Primary Completion

July 17, 2018

Study Completion

July 17, 2018

Last Updated

June 4, 2019

Record last verified: 2019-06

Locations

US(1)