Randomised clinical trial: macrogol/PEG 3350+electrolytes versus prucalopride in the treatment of chronic constipation -- a comparison in a controlled environment.
R Cinca, D Chera, H-J Gruss...
https://pubmed.ncbi.nlm.nih.gov/23480216Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID07277907
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation A Multicenter, Randomized Controlled Trial
Led by Third Military Medical University · Updated on 2026-01-20
346
Participants Needed
15
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Slow-transit constipation (STC) is a common type of chronic constipation characterized by a decreased urge to defecate and fewer than three spontaneous bowel movements per week. This condition often worsens over time and can cause straining, hard stools, abdominal pain, bloating, and in severe cases, fecal impaction and colonic obstruction. Current treatments have limitations due to side effects and tolerance issues, so this study aims to evaluate the effectiveness and safety of lubiprostone specifically for STC patients. Participants in this study will receive either lubiprostone, an oral drug that activates chloride channels to increase intestinal fluid secretion and improve bowel movement, or polyethylene glycol (PEG), a widely used laxative. Lubiprostone will be taken twice daily at 24 micrograms with food for 4 weeks, while PEG will be taken twice daily at 10 grams dissolved in water for the same duration. Medication adherence will be monitored with patient diaries and pill counts. During the study, participants' bowel movement frequency and related symptoms will be closely tracked from two weeks before treatment through four weeks after starting medication. Assessments include changes in spontaneous bowel movements, stool form, straining, constipation scores, quality of life, patient satisfaction, and adverse reactions such as nausea or abdominal pain. The main measure is the change in bowel movement frequency in the first week of treatment. The total participation period covers treatment and follow-up over several weeks to monitor safety and treatment effects.
CONDITIONS
Brief Title
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 per week
- More than 20% of radio-paque markers localized in the colon after 72 hours based on colonic transit studies
- Able to complete the bowel movement diary and study questionnaires as required
- Agreed to use effective contraception from consent until 3 months after last dose
- Aged 18 years or older, both males and females
You will not qualify if you...
- 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 previous use of 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 unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants receive either Lubiprostone or Polyethylene Glycol to treat slow transit constipation. Treatment lasts for 4 weeks with medication taken twice daily.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 15 locations
1
Bishan Hospital of Chongqing
Bishan, Chongqing Municipality, China, 402760
Not Yet Recruiting
2
the People's Hospital of HeChuan Chongqing
Hechuan, Chongqing Municipality, China, 401533
Not Yet Recruiting
3
Shapingba Hospital, Chongqing University
Shapingba, Chongqing Municipality, China, 400033
Not Yet Recruiting
4
The Chenjiaqiao Hospital of ShaPingba District of Chongqing
Shapingba, Chongqing Municipality, China, 401331
Not Yet Recruiting
5
Army Medical Center (Daping Hospital)
Yuzhong, Chongqing Municipality, China, 400042
Actively Recruiting
6
Gansu Province Central Hospital
Lanzhou, Gansu, China, 730079
Not Yet Recruiting
7
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150007
Not Yet Recruiting
8
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430062
Not Yet Recruiting
9
General Hospital of the Eastern Theater Cammand of the PLA
Nanjing, Jiangsu, China, 210002
Not Yet Recruiting
10
Renji Hospital, Shanghai Jiaotong University
Pudong, Shanghai Municipality, China, 200127
Not Yet Recruiting
11
Xijing Hospital
Xi’an, Shanxi, China, 710032
Not Yet Recruiting
12
Chengdu Analrectal Hospital
Chengdu, Sichuan, China, 610017
Not Yet Recruiting
13
The General Hospital of Western Theater Command
Chengdu, Sichuan, China, 610036
Not Yet Recruiting
14
The Second People's Hospital of Yibin
Yibin, Sichuan, China, 644000
Not Yet Recruiting
15
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
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Research Team
Y
yansen Huang, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation.
Lin Chang, William D Chey, Aamer Imdad...
https://pubmed.ncbi.nlm.nih.gov/37211380A Randomized, Double-Blind, Placebo-Controlled Trial to Examine the Effectiveness of Lubiprostone on Constipation Symptoms and Colon Transit Time in Diabetic Patients.
Jennifer Christie, Sagar Shroff, Nikrad Shahnavaz...
https://pubmed.ncbi.nlm.nih.gov/27922028Lubiprostone Is Effective in the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Fan Li, Tao Fu, Wei-Dong Tong...
https://pubmed.ncbi.nlm.nih.gov/27046523A randomized, placebo-controlled trial of lubiprostone for opioid-induced constipation in chronic noncancer pain.
M Mazen Jamal, Atoya B Adams, Jan-Peter Jansen...
https://pubmed.ncbi.nlm.nih.gov/25916220Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease.
W G Ondo, C Kenney, K Sullivan...
https://pubmed.ncbi.nlm.nih.gov/22573627Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with irritable bowel syndrome with constipation.
W D Chey, D A Drossman, J F Johanson...
https://pubmed.ncbi.nlm.nih.gov/22251419Lubiprostone: in constipation-predominant irritable bowel syndrome.
Natalie J Carter, Lesley J Scott
https://pubmed.ncbi.nlm.nih.gov/19537839Lubiprostone increases spontaneous bowel movement frequency and quality of life in patients with chronic idiopathic constipation.
Shin Fukudo, Michio Hongo, Hiroshi Kaneko...
https://pubmed.ncbi.nlm.nih.gov/25158925A randomized study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain.
Byron Cryer, Seymour Katz, Ricardo Vallejo...
https://pubmed.ncbi.nlm.nih.gov/24716835