Clinicians may benefit from monitoring clinical trials, as emerging evidence can refine diagnostic accuracy, guide therapeutic decision making, and support improved patient outcomes. By receiving a more individualized care plan, patients with constipation or health issues occurring alongside constipation may achieve symptom relief more efficiently.
In observance of the 2025 Constipation Awareness Month this December, we are highlighting five ongoing or upcoming clinical trials focusing on constipation and related disorders.
Quick View Table of Active and Upcoming Clinical Trials for Constipation
| Study Title | Recruiting | Phase | Estimated Enrollment | Start Date | Estimated Primary Completion |
|---|---|---|---|---|---|
| Assessing Tenapanor as a Treatment of CF-related Constipation | Yes | 3 | 25 | June 2025 | February 2026 |
| Maralixibat in Patients With Cystic Fibrosis and Constipation, A Within-Subjects Pilot Study | Not Yet | 3 | 20 | July 2024 | June 2026 |
| Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years | Yes | 3 | 180 | November 2022 | December 2025 |
| Home Transcutaneous Electrical Acustimulation (TEA) (Home-TEA) | Yes | 3 | 160 | November 2022 | September 2026 |
| Use of a Squatting Assist Device in Patients with Constipation | Yes | 2 | 85 | September 2016 | December 2025 |
Clinical Trials for Constipation Relief
Assessing Tenapanor as a Treatment of CF-related Constipation
- Sponsor: Massachusetts General Hospital
- Goal: This study seeks to understand tenapanor as a treatment for cystic fibrosis-related constipation (CFrC) in CF patients.
- Intervention: Tenapanor
- Primary Outcome Measure: Increase in spontaneous bowel movement (SBM) frequency
- Timeframe: Patients will record SBM frequency over the four-week treatment period.
- Study Details
- Source
Maralixibat in Patients With Cystic Fibrosis and Constipation, A Within-Subjects Pilot Study
- Sponsor: Children’s Hospital Los Angeles
- Goal: The primary aim of the study is to assess improvement in stool consistency in children (1 to 18 years of age) with cystic fibrosis.
- Intervention: Maralixibat 9.5 MG/ML [Livmarli]
- Primary Outcome Measure: Change in stool consistency by one point in Bristol scale or transition to Bristol scale >3 after study drug
- Timeframe: Baseline to three weeks
- Study Details
- Source
Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
- Sponsor: Ardelyx
- Goal: This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of tenapanor (25 mg and 50 mg) in pediatric patients (≥12 and <18 years old) with IBS-C when administered twice daily (BID) for 12 consecutive weeks.
- Interventions: Tenapanor 50 mg, tenapanor 25 mg bid, placebo
- Primary Outcome Measure: 6/12-week APS (abdominal pain and SBM) +2 response
- Timeframe: 12 weeks
- Study Details
- Source
Home Transcutaneous Electrical Acustimulation (TEA) (HOME-TEA)
- Sponsor: University of Michigan
- Goal: Investigate the potential of TEA to treat abdominal pain in participants with IBS with constipation (IBS-C).
- Interventions: TEA, Lexapro
- Primary Outcome Measures: Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey; Change in global abdominal pain.
- Timeframes: Daily for 14 weeks; Weekly for 14 weeks.
- Study Details
- Source
Use of a Squatting Assist Device in Patients With Constipation
- Sponsor: Mayo Clinic
- Goal: [Researchers will] evaluate the benefits of a footstool on symptoms and anorectal functions in constipated patients.
- Interventions: Squatting assist device, sham squatting assist device
- Primary Outcome Measure: Change in mean weekly complete spontaneous bowel movement (CSBM) frequency
- Timeframe: Baseline, four weeks
- Study Details
- Source
Related Guidelines:
Diagnosis and Management of Chronic Constipation
- World Gastroenterology Organisation
- October 2025
Dietary Management of Chronic Constipation in Adults
- British Dietetic Association
- October 2025
Evaluation and Management of Chronic Constipation
- American Society of Colon and Rectal Surgeons
- October 2024
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