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NCT00844831 · ClinicalTrials.gov registry record · Phase 4

Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit

A Phase 4 study, sponsored by University of Louisville.

Completed
Registry status
Phase 4
Development phase
25
Enrollment target

NCT00844831: Completed Phase 4 study, sponsored by University of Louisville.

NCT00844831 is a Phase 4 study that has completed, run by University of Louisville. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00844831, a Phase 4 study, has completed, sponsored by University of Louisville.

COMPLETED
Registry status
Phase 4
Development phase
25 participants
Enrollment target

Study Summary

Patients with constipation often have bloating and abdominal distension. It is unclear if this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce small bowel and colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms of dyspepsia and constipation.

Primary Outcome

Percent of patients with bacterial overgrowth before and after treatment.

Interventions

  • DRUG Lubiprostone

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2009-05
Est. Completion 2011-05
Phase Phase 4
University of Louisville

217 total trials

What the finished NCT00844831 record still lists

NCT00844831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Lubiprostone is the first listed.

NCT00844831 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00844831 about?

NCT00844831 is a clinical study titled "Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit". Patients with constipation often have bloating and abdominal distension. It is unclear if this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce small bowel and colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms o...

What is the current status of trial NCT00844831?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2009-05. Estimated completion is 2011-05.

What interventions are being tested in trial NCT00844831?

The interventions under investigation include: Lubiprostone (DRUG).

Who is sponsoring clinical trial NCT00844831?

This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00844831's enrollment target sits among peer trials

25 1669th of 2000 higher than 302 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00844831, the US trial registry maintained by the National Library of Medicine. NCT00844831 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.