Lubiprostone, Colonic Motility and Sensation
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being done to evaluate the effects of lubiprostone, a drug approved and used
      for constipation, on pattern of contractions of the colon and the colon's sensitivity to
      distension.
    

Detailed description: 
      This was a trial of healthy adults to compare the effects of oral lubiprostone, 24 microgram
      per day and placebo for three days, on sensation and contractions of the colon using
      validated methods.

      On days 1 and 2, participants took the study medication with their breakfast and recorded the
      time. On day 2 starting at 4:00 pm, participants started a polyethylene glycol-based bowel
      preparation to cleanse the colon. After overnight bowl preparation, participants reported
      fasting to the study center at 7:00 am on day 3. Colonic sensorimotor functions were assessed
      by an endoscopically placed barostat-manometric assembly.

      After 30 minutes of rest following tube placement, fasting colonic tone, colonic compliance
      and colonic sensation were tested. The last dose of medication was ingested and 1 hour later
      the same colonic functions, as well as colonic response to a standardized meal of a
      1,000-kilocalorie chocolate milkshake were assessed. The participant was able to leave the
      study center in the afternoon, after a meal had been ingested (if desired).

      Details on colonic tube placement: A flexible sigmoidoscopy was performed to evaluate the
      left side of the colon and to place a Teflon-coated guide wire beyond the splenic flexure.
      The colon was deflated as the sigmoidoscope was removed and a barostat catheter (constructed
      at Mayo Clinic, Rochester, MN) with six manometric point sensors and a polyethylene balloon
      was introduced into the colon over the guide wire. The barostat catheter was positioned in
      the mid-descending or upper sigmoid colon with the aid of fluoroscopy. The final position of
      the barostatically controlled balloon was confirmed by fluoroscopy. After the colonic tube
      placement, participants rested for 30 min. The catheter was connected to a rigid piston
      barostat machine. After transient inflation of the barostat bag to a volume of 75 ml to
      ensure it was unfolded, it was deflated. Thereafter, it was inflated in 2 mm Hg increments to
      baseline operating pressure, which was defined as 2 mm Hg above the minimal distension
      pressure at which respiratory excursions were clearly recorded by the barostat tracing.
    

Intervention name(s): lubiprostone; Placebo; Bowel preparation
Intervention type(s): Drug; Drug; Other
Intervention description(s): Lubiprostone 24 micrograms, one dose daily for three days in 30 subjects; Placebo medication given for three days; Polyethylene glycol-based bowel preparation
Other intervention name(s): Amitiza; NuLytely
Intervention MeSH terms: Lubiprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: lubiprostone; colon; motility; sensation