A Phase 3 interventional study of Lubiprostone and Polyethylene glycol (PEG ) in Slow Transit Constipation and Pharmacotherapy, sponsored by Third Military Medical University. Recruiting at 20 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Third Military Medical University · Phase 3, Interventional, and Treatment
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.
Slow-transit constipation (STC) is a common subtype of chronic constipation, accounting for up to 30% of cases. Its clinical hallmarks include a diminished or absent urge to defecate and a significantly reduced stool frequency (spontaneous bowel movements \<3 per week). The condition often follows a prolonged and progressively worsening course, characterized by straining, passage of hard stools, and associated symptoms such as abdominal pain and bloating. In severe cases, fecal impaction and consequent colonic obstruction may occur, substantially impairing the patient's quality of life.
Non-surgical management, including lifestyle modifications, pharmacological therapy, gut microbiome modulation, and sacral nerve stimulation, remains the first-line approach for most STC patients. Among these, pharmacotherapy is central. Conventional agents include bulk-forming, osmotic, and stimulant laxatives, as well as prokinetics. However, these options are often limited by adverse effects-such as abdominal pain, bloating, rash, drug dependence, malabsorption, and electrolyte imbalances-and the development of tolerance with long-term use. This frequently leaves patients with inadequate relief, creating an urgent need for more effective and safer therapeutics.
Lubiprostone, a chloride channel activator that functions as a secretagogue, enhances intestinal fluid secretion and motility. Its efficacy and safety in chronic idiopathic constipation and irritable bowel syndrome with constipation are well-documented, leading to approvals by the U.S. FDA for these indications. Nevertheless, specific data on its use for STC, a distinct pathophysiological entity, is lacking. This study is therefore designed to evaluate the clinical efficacy and safety of lubiprostone in an STC population, with the aim of generating new evidence to inform precise treatment strategies for this condition.
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's planned enrollment of 346 is above the median of 75 across 884 interventional studies indexed under Constipation.
Browse Constipation studies →Third Military Medical University is the lead sponsor of 83 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lubiprostone is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of human gastrointestinal epithelial cells, thereby increasing chloride-rich fluid secretion. Although the mechanism is unclear, this may then decrease intestinal transit time, allowing the passage of stool and alleviating symptoms of constipation.
Drug: Lubiprostone
Polyethylene glycol (PEG ) is an established osmotic laxative, widely available worldwide for the treatment of functional constipation in adults and children.
Drug: Polyethylene glycol (PEG )
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.
The change in spontaneous bowel movements (SBMs) frequency from baseline during the first week
The change from baseline in the weekly average number of SBMs reported during the first week after treatment initiation
Time frame: From 2 weeks prior to the first dose through 4 weeks after treatment initiation
The percentage of patients with SBMs within 24 hours after the first intake of the study drug
Time frame: Day 1 after treatment initiation
Time to first SBM occurrence after treatment initiation
Time frame: Up to 4 weeks after treatment initiation
The percentage of patients reporting 3 or more SBMs/wk
Time frame: From 2 weeks prior to the first dose through 4 weeks after treatment initiation
The percentage of patients achieving an increase of ≥1 SBMs/week from baseline
Time frame: From 2 weeks prior to the first dose through 4 weeks after treatment initiation
The change from baseline in the weekly average number of SBMs at weeks 2, 3, and 4
Time frame: From 2 weeks prior to the first dose through 4 weeks after treatment initiation
The change from baseline in the Bristol Stool Form Scale (BSFS) values for SBMs at weeks 1 and 4
The BSFS values can be described as the following 7 types: 1. separate hard lumps; 2. sausage-shaped but lumpy; 3. like a sausage but with cracks; 4. like a sausage, smooth and soft; 5. soft blobs with clear cut edges; 6. a mushy stool; and 7. watery.
Time frame: The 1 and 4-week treatment period has been completed
The change from baseline in the ratings of straining associated with SBMs at weeks 1 and 4
The ratings of straining will be described using a 5-point Likert scale: 0= absent; 1= mild; 2= moderate; 3= severe; and 4= very severe
Time frame: The 1 and 4-week treatment period has been completed
The change from baseline in the Wexner constipation score at weeks 1 and 4
The Wexner Constipation Score will be recorded in terms of scores. Questions examine constipation in its clinical expressions. Each question is answered on a scale of 0 to 4. The scale ranges from 0 (best) to 30 (worst)
Time frame: The 1 and 4-week treatment period has been completed
The change from baseline in the Patient Assessment of Constipation Quality of Life (PAC-QOL) score at weeks 1 and 4
The full PAC-QOL consists of 28 items rated on a 5-point Likert scale ("1" = Not at all / None of the time; "2" = A little bit / A little of the time; "3" = Moderately /Some of the time; "4" = Quite a bit / Most of the time; "5" = Extremely / All of the time)
Time frame: The 1 and 4-week treatment period has been completed
The patients' satisfaction scores at weeks 1 and 4
The patients' satisfaction scores will be described using a 5-point Likert scale: 0= Not at all; 1= A little bit; 2= Moderately; 3= Quite a bit; and 4= Extremely
Time frame: The 1 and 4-week treatment period has been completed
The rate of adverse reactions, including nausea, diarrhea, and abdominal pain.
Time frame: Up to 4 weeks after treatment initiation
Plan to share: No
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Studies of the drug tested here: Lubiprostone
Third Military Medical University