Functional Constipation: A Phase 2 Dose Finding Study Evaluating the Safety and Efficacy of Linaclotide in Pediatric Subjects 6 Months to Less Than 2 Years of Age

You may be able to join if

• The Subjects' LAR/parent/guardian must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
• Individuals must be 6 months to less than 1 year and 11 months old, at the time the LAR/parent/guardian signs the informed consent in alignment with local requirements.
• Subject has weight-for-height/length ratio of ≥ 3rd percentile for age 6 months to less than 24 months at the time the LAR/parent/guardian has provided signed consent. (Investigators can choose to use CDC or WHO growth charts based on their current clinical practice).
• Subject meets Rome IV criteria for FC as outlined below: For at least 1 month before Screening (Visit 1), the subject must meet 2 or more of the following (a-e): a) 2 or fewer defecations per week (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) b) History of excessive stool retention c) History of painful or hard bowel movements (BMs) d) History of large-diameter stools e) Presence of a large fecal mass in the rectum Accompanying symptoms may include irritability, decreased appetite, and/or early satiety.
• Based on the eDiary, the Subject has an average of ≤ 2 spontaneous bowel movements (SBMs) per week during the 14 days before the enrollment/randomization day and up to the enrollment/randomization (including the morning eDiary assessments reported before administration of first dose of study intervention on the enrollment/randomization day). An SBM is defined as a bowel movement (BM) that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM.