Two publications report adult chronic-constipation trials and a pediatric functional-constipation trial. They do not cover the full irritable-bowel-syndrome program or every currently labeled age group.12
Bottom line from this bounded source set
Randomized trials reported improved bowel-movement measures over 12 weeks. Diarrhea is an important adverse effect; the pediatric trial included a serious dehydration event related to severe diarrhea.12
Reviewed study record
Adult chronic constipation: two trials
Design
Two randomized, double-blind, placebo-controlled 12-week trials tested two active groups.1
Population
1,276 adults with chronic constipation participated across the trials.1
Outcomes reported
The prespecified bowel-response endpoint was reached by approximately 16–21% of active-group participants versus 3–6% with placebo. Diarrhea led to discontinuation in 4.2% of active-group participants.1
Limitations
One publication contains two trials. Short follow-up cannot establish long-term benefit or uncommon harms, and the results do not automatically extend to other diagnoses or ages.1
330 children aged 6–17 years were randomized; 328 received treatment and 293 completed.2
Outcomes reported
The adjusted between-group difference was 1.17 additional spontaneous bowel movements per week. Diarrhea occurred in seven of 164 active-group and three of 164 placebo participants; one active-group participant required hospitalization for dehydration.2
Limitations
The trial addresses functional constipation in the enrolled age range. Its findings cannot establish safety in younger children or replace age-specific label warnings.2
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1056/nejmoa1010863. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/s2468-1253(23)00398-9. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗