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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
346
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.
Bishan Hospital of Chongqing
Bishan, Chongqing Municipality, China
NOT_YET_RECRUITINGthe People's Hospital of HeChuan Chongqing
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
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Hechuan, Chongqing Municipality, China
Shapingba Hospital, Chongqing University
Shapingba, Chongqing Municipality, China
NOT_YET_RECRUITINGThe Chenjiaqiao Hospital of ShaPingba District of Chongqing
Shapingba, Chongqing Municipality, China
NOT_YET_RECRUITINGArmy Medical Center (Daping Hospital)
Yuzhong, Chongqing Municipality, China
RECRUITINGGansu Province Central Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
NOT_YET_RECRUITINGGeneral Hospital of the Eastern Theater Cammand of the PLA
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGRenji Hospital, Shanghai Jiaotong University
Pudong, Shanghai Municipality, China
NOT_YET_RECRUITING...and 5 more locations
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