Constipation Clinical Trial
Official title:
The Impact of Lubiprostone on Mucus Secretion in Asymptomatic Volunteers and Patients With Chronic Constipation
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.
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 outcome).
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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