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NOW ENROLLINGGastroenterologySponsor: AbbVie
Linaclotide for Pediatric Functional Constipation (Ages 2–5)
A study to assess adverse events and change in symptoms with Linaclotide versus placebo in pediatric subjects with functional constipation.
About this study
This study evaluates the safety and efficacy of Linaclotide compared to placebo in pediatric subjects ages 2 to 5 years with functional constipation (FC). Participants attend regularly scheduled visits at VMRC for symptom assessment, safety monitoring, and study medication administration. Caregivers complete a daily diary capturing bowel movements and symptoms.
You may qualify if
- Child between 2 and 5 years of age at screening
- Diagnosed with functional constipation per modified Rome IV criteria
- Caregiver willing and able to maintain a daily symptom diary
- Caregiver willing to attend all scheduled study visits at VMRC Miami
You may not qualify if
- Known structural, metabolic, or anatomical cause of constipation
- Active or recurrent gastrointestinal disease unrelated to FC
- Recent participation in another investigational drug study
- Any contraindication to Linaclotide as judged by the investigator