Will Lubiprostone Help Children with Functional Constipation?

A recent open-label study of lubiprostone examined its use in children younger than 18 years (2007-2008) at 22 U.S. centers (JPGN 2014; 58: 283-91).

Lubiprostone (Amitiza) activates chloride-channel protein-2 in the gastrointestinal epithelium and promotes secretion of chloride ions and fluid.  This results in more frequent bowel movements (BMs) and improved motility.  To determine its safety and effectiveness in the pediatric population, the investigators enrolled 127 patients (124 were treated and analyzed and 109 completed the 4-week study).  After a 2-week observation period, several doses of lubiprostone were compared: 12 μg QD, 12 μg BID, 24 μg BID.  There was no placebo group.  The mean age of the participants was 10.2 years.


  • Mean spontaneous BM frequency increased from baseline: 3.1/week versus 1.5/week.  Overall, at each week in treatment ≥ 43% achieved ≥ 3 spontaneous BMs/week.
  • 62% experienced a spontaneous BM within 48 hours of starting treatment.
  • Common adverse reactions: Nausea (18.5%), vomiting (12.1%), diarrhea (8.1%), abdominal pain (7.3%) and headache (5.6%). Overall, 65% of patients experienced ≥ 1 adverse effect and this was highest (78%) in the subset of patients receiving the highest dosage

Bottomline: Current guidelines recommend osmotic agents like polyethylene glycol (PEG) (Miralax) as first-line treatment.  This short-term study shows lubiprostone may be an alternative in nonresponders, though more data on long-term outcomes are needed.

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3 thoughts on “Will Lubiprostone Help Children with Functional Constipation?

  1. what dose did  they use ?  whats u r personal opinion ?Have u used it ?

    Dr.Yogesh Waikar Pediatric Gastroenterology & Hepato-biliary Pancreatic sciences. Central India. Pedgihep Pedgihep PEDGIHEP is an offshoot of the co-ordinated activity by EB-PGHN group: Evidence-Based Pediatric Gastroenterology, Hepatology and Nutrition. This is a sincere attempt by dedicated subspecialists all over the world to improve and add on to the present status of… View on http://www.pedgihep.jigsy.com Preview by Yahoo

    • In the post, I briefly alluded to the dosing. Patients received 4 weeks of open-label lubiprostone at doses of 12 μg once daily (QD), 12 μg twice daily (BID), or 24 μg BID based on age and weight. I have used the medication in some older teens. I need more time to develop an opinion.

  2. Pingback: Lubiprostone Study: Ineffective for Pediatric Functional Constipation | gutsandgrowth

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