Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Elobixibat: Elobixibat (5 mg, 10 mg or 15 mg) (Dose as prescribed by the treating physician)
Per Oral
For 8 weeks
Control Intervention1: Prucalopride: Prucalopride (1mg or 2 mg
(Dose as
Sponsors
Dayanand Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: (1) Adults aged 18 years to 65 years. (2) Diagnosed with functional constipation (FC) or irritable bowel syndrome with constipation (IBS-C) as per Rome IV criteria. (3) History of inadequate response to conventional treatments for constipation for at least three months; and have been prescribed Elobixibat or Prucalopride by the treating physician (4) Willing and able to provide written informed consent. (5) Willing to comply with study procedures, including follow-up visits and assessments over the study period.
Exclusion criteria
Exclusion criteria: (1) Presence of secondary causes of constipation, including metabolic (e.g., hypothyroidism, diabetes mellitus), neurological (e.g., Parkinson s disease, multiple sclerosis), or drug-induced constipation. (2) Evidence of organic gastrointestinal diseases such as inflammatory bowel disease (IBD), colorectal cancer, diverticulitis, or strictures. (3) History of major abdominal surgery affecting gastrointestinal motility, except for uncomplicated appendectomy, cholecystectomy, or hysterectomy. (4) Use of laxatives, enemas, prokinetics, opioids, or other constipation-related medications within two weeks prior to enrollment. (5) Known hypersensitivity or contraindications to elobixibat or prucalopride. (6) Severe psychiatric disorders (e.g., major depression, schizophrenia) that may interfere with study participation or compliance. (7) Pregnancy or lactation. (8) Severe cardiovascular diseases, including uncontrolled hypertension or a history of myocardial infarction. (9) Any other severe systemic illness that could impact gastrointestinal motility or study outcomes (e.g., chronic kidney disease stage IV-V, advanced liver disease). (10) Participation in another clinical trial within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in the number of complete spontaneous bowel movements (CSBMs) per week.Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool consistency (Bristol Stool Form Scale) Time to first CSBM Patient-reported symptom relief (PAC-SYM, IBS-SSS scores) Patient satisfaction with treatment Requirement of rescue medication Incidence of adverse events Degree of straining during defecationTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Omesh Goyal
Dayanand Medical College and Hospital
Outcome results
None listed