A Study of the Effectiveness and Safety of Lubiprostone in Pediatric Patients with Functional Constipation


About this study

The purpose of this study is to assess the effectiveness and safety of Lubiprostone in pediatric patients, aged ≥ 6 years to < 18 years, diagnosed with functional constipation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation
  • At least 6 years of age but less than 18 years of age at the time of randomization
  • Only stable dose selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase (MAO) inhibitors are allowed if subject is taking antidepressants


Exclusion Criteria

  • Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel syndrome (IBS), affecting GI motility or defecation
  • Untreated fecal impaction at the time of screening
  • Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Imad Absah, M.D.

Closed for enrollment

More information


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