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A prospective, controlled clinical study to explore the effects of rubiprostol on intestinal microecology in patients with chronic idiopathic constipation

A prospective, controlled clinical study to explore the effects of rubiprostol on intestinal microecology in patients with chronic idiopathic constipation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101998
Enrollment
Unknown
Registered
2025-05-07
Start date
2025-08-18
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic idiopathic constipation

Interventions

Lubprostanone group:Treatment with rubiprostol (24ug bid po*4 weeks)

Sponsors

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-70 years old (including the critical value), male and female; (2) <3 spontaneous defecations per week (spontaneous defecation is defined as defecation without the use of laxatives, suppositories, or enemas in the past 24 hours), and at least one of the following symptoms has occurred during at least 25% of defecations in at least 12 weeks (not necessarily consecutive) within the past 6 months: Exertion, the need for manual assistance, lumpy or hard stools, and incomplete emptying; (3) No special colonoscopy and other auxiliary examinations within 1 year.

Exclusion criteria

Exclusion criteria: (1) Patients with severe heart and cerebrovascular diseases, connective tissue diseases, Parkinson's disease, spinal cord injury, and severe liver and kidney insufficiency; (2) Those who are intolerant or allergic to the experimental drug; (3) Patients with confirmed digestive tract tumors or other advanced system tumors; (4) Women who have positive pregnancy tests or have pregnancy plans and breastfeeding women; (5) Those who cannot cooperate with disease examination and treatment; (6) Patients with a history of abdominal surgery, diabetes and inflammatory bowel disease; (7) Within 30 days before the start of the trial, tricyclic antidepressants, antibiotics, mototropic drugs, laxatives other than the prescription of serol, probiotics, etc., had been used with the same mechanism of action as the study drugs; (8) Constipation is secondary to other diseases (such as severe liver dysfunction, anxiety and depression, metabolic diseases, malignant tumors, renal dysfunction, endocrine diseases) or interventions in the past 5 years (such as drugs);

Design outcomes

Primary

MeasureTime frame
Stool flora 16s sequencing;

Secondary

MeasureTime frame
Constipation symptom;Constipation Patients Quality of Life Scale (PAC-QOL);Wexner rating Scale;

Countries

China

Contacts

Public ContactZhao Qi

Shandong Provincial Hospital

caoruofan123@163.com+86 156 1011 7696

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026