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The Effect of Lubiprostone on Patterns of Contractions in the Small Bowel in Female Patients With Constipation Irritable Bowel Syndrome (C-IBS)

2014-08-27 03:15:17 | BioPortfolio

Summary

Irritable Bowel Syndrome is a common disorder, defined by symptom-based diagnostic criteria. The pathogenesis is multifactorial and gut motor dysfunction is considered to be a contributing factor. Dysmotility affects both the small bowel and colon. Changes in motor patterns in the small bowel in IBS are quantitative rather than qualitative with no distinct patterns to distinguish patients from healthy individuals. Changes in motor patterns can potentially affect transit of bowel contents. Indeed, variation in intestinal transit was reported in patients with IBS.

Lubiprostone is a novel agent that is FDA approved for the treatment of chronic constipation. More recently, 2 randomized, double-blind, placebo-controlled trials showed the drug to be effective in relieving symptoms in patients with C-IBS, resulting in approval for female patients with C-IBS at a dose of 8 micrograms twice a day.

The investigators hypothesize that lubiprostone works not just as a laxative, but by actually altering motility patterns in the small intestine of female IBS-C patients. These alterations could be measured through High Resolution Manometry (HRM), a new technique that uses catheters with multiple closely spaced sensors and special software that uses color schemes to portray a pressure gradient. This technique allows a detailed assessment of the direction and spread of contractions. The investigators would like to use HRM to see if lubiprostone affects intestinal contractions. The investigators would like to achieve this by administering blinded participants lubiprostone and placebo while they are undergoing HRM and seeing if any changes in contractions occur. Participants will be recruited both from the investigator's clinic and by word of mouth. If interested, potential subjects will be provided with a copy of the consent form for review. Patients will be informed that after they have had an opportunity to review the consent form, they may contact the study team to further discuss the research and address any questions or concerns they may have.

Participants will undergo a screening visit and a manometry visit. During the screening visit the investigators will determine eligibility, including application of inclusion/exclusion criteria and administration of a pregnancy test. Then during the manometry visit patients will receive the two capsules,lubiprostone and placebo, three hours apart during HRM. Patients will receive each capsule only once, but they will not know which order they're receiving them in.

Description

Irritable Bowel Syndrome (IBS) is a common disorder, defined by symptom-based diagnostic criteria. The pathogenesis is multifactorial, and gut motor dysfunction is considered to be a contributing factor. Dysmotility affects both the small bowel and the colon. Changes in motor patterns in the small bowel in IBS are quantitative rather than qualitative, with no distinct patterns to distinguish patients from healthy individuals. Changes in motor patterns can potentially affect transit of bowel contents and contribute to symptoms. Indeed, variation in intestinal transit was reported in patients with IBS. Small bowel transit studies, using scintigraphy, radio-opaque markers and hydrogen breath test, have shown that transit is delayed in constipation predominant-IBS (IBS-C) and accelerated in diarrhea predominant-IBS (IBS-D).

Lubiprostone is a novel agent that has been FDA approved for the treatment of adult males and females with chronic constipation. More recently, 2 randomized, double-blind, placebo-controlled trials showed the drug to be effective in relieving symptoms in patients with C-IBS, resulting in approval for female patients with C-IBS, at a dose of 8 micrograms twice a day.

We hypothesize that lubiprostone works not just as a laxative, but by actually altering motility patterns in the small intestine of female IBS-C patients. These alterations could be measured through High Resolution Manometry (HRM), a new technique that uses catheters with multiple, closely spaced sensors, and special software that uses color schemes to portray a pressure gradient. This technique allows a detailed assessment of the direction and spread of individual contractions.

We would like to use HRM to see if lubiprostone affects intestinal contractions. We would like to achieve this by administering blinded participants lubiprostone and placebo while they are undergoing HRM and seeing if any changes in contractions occur. Participants will be recruited both from the investigator's own clinic and by word of mouth. Patients of the investigators will be approached by a member of the research team during a regularly scheduled clinic visit. If interested, potential subjects will be provided with a copy of the consent form for review. Patients will be given ample time to review the consent form with friends, family, and/or other physicians. Patients will be informed that after they have had an opportunity to review the consent form, they may contact the study team to schedule an appointment with one of the co-investigators to further discuss the research and address any questions or concerns the patient may have. Once all the potential subject's issues and concerns have been addressed, and the individual would like to enroll in the study, an investigator or co-investigator will obtain informed consent. Referring physicians will be asked to give their patients the contact information for the study team and the recruitment process will proceed as described above.

Participants will undergo two visits: a screening visit and a manometry visit. During the screening visit we will determine eligibility, including application of inclusion/exclusion criteria and administration of a pregnancy test. Then during the manometry visit, patients will receive the two capsules (lubiprostone and placebo), three hours apart during HRM. Patients will receive each capsule only once, but they will not know which order they're receiving them in.

Patients may receive lubiprostone without participating in the research study. As lubiprostone is FDA approved, the indications would be the same, however, patients receiving the drug under standard of care would not be undergoing the HRM or receiving a placebo capsule. Patients also may not be required to undergo a washout from their standard medication before starting on lubiprostone.

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Conditions

Constipation-predominant Irritable Bowel Syndrome

Intervention

Lubiprostone

Location

Cedars-Sinai Medical Center
Los Angeles
California
United States
90048

Status

Not yet recruiting

Source

Cedars-Sinai Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:17-0400

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