Clinical Trial: Lubiprostone and Mucus Secretion in Patients With Chronic Constipation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Impact of Lubiprostone on Mucus Secretion in Asymptomatic Volunteers and Patients With Chronic Constipation

Brief Summary:

The investigators hypothesize that the symptoms of chronic constipation in some patients are developed due to diminished production and secretion of the alimentary tract mucus resulting in poor lubrication.

Therefore, the investigators assume that administration of lubiprostone may restore this lubrication impairment by stimulation of mucus production and secretion within the gastrointestinal tract.


Detailed Summary:

Specific Aim 1. To test the effect of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucus production in 20 asymptomatic volunteers and 20 patients with chronic constipation in basal conditions (primary outcome).

Specific Aim 2. To explore the effect of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucus production in 20 asymptomatic volunteers and 20 patients with chronic constipation during stimulation of gastric secretion with pentagastrin, mimicking the meal-stimulated conditions (primary outcome).

Specific Aim 3. To address the influence of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucin production, the major component of mucus, in 20 asymptomatic volunteers and 20 patients with chronic constipation in basal conditions (primary outcome).

Specific Aim 4. To test the influence of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucin production, the major component of mucus, in 20 asymptomatic volunteers and 20 patients with chronic constipation during stimulation of gastric secretion with pentagastrin, mimicking the meal-stimulated conditions (primary outcome).

Specific Aim 5. To explore the impact of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on viscoelasticity of gastric mucus in 20 asymptomatic volunteers and 20 patients with chronic constipation in basal conditions (secondary outcome).

Specific Aim 6. To address the impact of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on viscoelasticity of gastric mucus in 20 asymptomatic volunteers and 20 patients with chronic constipation during stimulation of gastric secretion with pentagastrin, mimicking the meal-stimulated conditions (secondary outcom
Sponsor: Texas Tech University Health Sciences Center, El Paso

Current Primary Outcome: Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. [ Time Frame: Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between. ]

The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).


Original Primary Outcome: Increase in volume and concentration of mucus and mucin secretion per millileter of solution in controls and patients with chronic constipation. [ Time Frame: Measured at baseline and 1 week after baseline ]

The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).


Current Secondary Outcome: Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation. [ Time Frame: Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between. ]

The viscoelasticity of gastric mucus(centipoises) was measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).


Original Secondary Outcome: Increase in amount of viscoelasticity of gastric secretion in controls and patients with chronic constipation. [ Time Frame: Measured at baseline and 1 week after baseline ]

The viscoelasticity of gastric mucus(Ctpois) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).


Information By: Texas Tech University Health Sciences Center, El Paso

Dates:
Date Received: September 14, 2011
Date Started: August 2011
Date Completion:
Last Updated: November 10, 2015
Last Verified: November 2015