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: Trial 303
Design
A randomized, double-blind, placebo-controlled 12-week trial tested two active groups.1
Population
Adults with chronic constipation participated; the abstract reports 1,276 participants across Trials 303 and 01 together, without a separate Trial 303 count.1
Outcomes reported
The primary bowel-response endpoint was reached by 21.2% and 19.4% in the two active groups, compared with 3.3% with placebo.1
Limitations
These are the Trial 303 efficacy results. The abstract’s 4.2% diarrhea-related discontinuation figure is reported across active groups in the two-trial publication and is not a separately appraised Trial 303 safety estimate. Follow-up was 12 weeks.1
Reviewed study record
Adult chronic constipation: Trial 01
Design
A randomized, double-blind, placebo-controlled 12-week trial tested two active groups.1
Population
Adults with chronic constipation participated; the abstract reports 1,276 participants across Trials 303 and 01 together, without a separate Trial 01 count.1
Outcomes reported
The primary bowel-response endpoint was reached by 16.0% and 21.3% in the two active groups, compared with 6.0% with placebo.1
Limitations
These are the Trial 01 efficacy results. The abstract’s combined participant count and diarrhea-related discontinuation figure should not be assigned to Trial 01 alone. Follow-up was 12 weeks.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 20, 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 ↗