Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation: A Multicenter, Randomized Controlled Trial
Third Military Medical University
346 participants
Nov 13, 2025
INTERVENTIONAL
Summary
Lubiprostone has established efficacy and a favorable safety profile in chronic constipation and irritable bowel syndrome with constipation (IBS-C). However, clinical data specifically supporting its use in slow-transit constipation (STC), a distinct subtype of chronic constipation, remains limited.
Eligibility
Inclusion Criteria7
- Patients voluntarily participated in the study and provided signed informed consent;
- Met the Rome IV diagnostic criteria for functional constipation;
- Had fewer than 3 spontaneous bowel movements (SBMs) per week;
- More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies;
- Were able to complete the bowel movement diary and study questionnaires as required by the study protocol;
- Agreed to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug;
- Aged 18 years or older, both males and females.
Exclusion Criteria15
- Pregnant or lactating women.
- Patients with severe outlet obstruction constipation (e.g. Oxford Grade IV or above for rectal prolapse, rectocele > 3.1 cm, puborectalis syndrome).
- Patients with hyperthyroidism or hypothyroidism.
- Patients with opioid-induced constipation.
- Patients with megacolon or megarectum.
- Patients with apparent mechanical intestinal obstruction.
- Patients with inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis).
- Patients with malignant tumors of the digestive system.
- Patients with a history of colorectal surgery.
- Patients with a previous history of taking lubiprostone.
- Patients with severe symptoms of depression or anxiety.
- Patients with known or suspected hypersensitivity to lubiprostone/polyethylene glycol 4000 or any excipients.
- Patients requiring medications for Parkinson's disease, antipsychotics, antimanic agents, or psychostimulants.
- Patients with severe cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurological, or psychiatric diseases.
- Other patients deemed by the investigator as unsuitable for participation in this trial.
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Interventions
Patients were instructed to orally ingest Lubiprostone Soft Capsules (provided by Nanjing Chia-Tai Tianqing Pharmaceutical Company) at a dose of 24 μg twice daily with food and water during breakfast and dinner. The capsules must be swallowed whole without splitting or chewing. The treatment duration was 4 weeks, and medication adherence was monitored through patient diaries and pill count of returned medication.
Subjects in the control group will receive the standard treatment of polyethylene glycol 4000 powder at a dosage of 10 g, twice daily. Each dose will be dissolved in 200-250 mL of water and administered orally for 4 weeks.
Locations(15)
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NCT07277907