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Home › Conditions › Functional Constipation

Functional Constipation

4 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Functional Constipation

11 trials tracked for Functional Constipation: 7 in phase 3 or 4 and 3 with published results. The most-cited published study has 51 citations.

11Trials tracked
7Phase 3 & 4
0Recruiting
3With published results
Phase distribution
Phase 4 1 Phase 3 6 Phase 2 4
  1. Phase 3 Lubiprostone for Children With Constipation Completed · 51 cited
  2. Phase 3 Lubiprostone in Children With Functional Constipation Completed · 51 cited
  3. Phase 3 Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC) Completed · 31 cited
  4. Phase 4 The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation Completed
  5. Phase 3 Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation Completed
  6. Phase 3 Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C Completed
Show 5 more trials
  1. Phase 3 Prucalopride in Pediatric Subjects With Functional Constipation Completed
  2. Phase 2 Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation Completed
  3. Phase 2 A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide Completed
  4. Phase 2 Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation Completed
  5. Phase 2 Effect of Ileal Bile Acid Transporter Inhibitor in Functional Constipation Completed

Showing the 11 most-cited and recently-updated of 11 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Functional Constipation: what the trials found

Linaclotide has demonstrated significant improvements in functional constipation (FC) outcomes. Specifically, patients treated with linaclotide showed a statistically significant increase in spontaneous bowel movement (SBM) frequency from baseline over 12 weeks (p<0.0001) and a significant improvement in stool consistency (p=0.0001) 6. Additionally, trials involving linaclotide were conducted in populations with IBS-C [1, 2].

Lubiprostone was evaluated in multiple Phase 3 trials for the management of functional constipation [4, 5, 7]. In one study, lubiprostone showed a mean SBM frequency ranging between 1.40 and 2.69 over a 12-week period 4.

Prucalopride was evaluated in a Phase 3 trial for functional constipation; however, results did not show statistically significant differences compared to the control group regarding responder rates (p=0.9002), SBM frequency of 3 or more per week (p=0.3520), or fecal incontinence episodes (p=0.5228) 8.

Magnesium Oxide was also evaluated in a Phase 4 trial for the management of functional constipation 3.

Recent results — preliminary, needs further review

  • A3309 showed non-significant results for colonic transit (p=0.059), colonic filling (p=0.81), and ascending colon emptying (p=0.084) in a Phase 2 study 10.
  • Litesse powder containing 12 g polydextrose was evaluated in a Phase 2 trial, but results are not yet corroborated 11.

For the clinician treating this condition

  • Linaclotide is associated with statistically significant improvements in both SBM frequency and stool consistency in patients with functional constipation 6.
  • Lubiprostone has been established through multiple trials as an intervention for functional constipation [4, 5, 7].
  • Prucalopride did not demonstrate statistically significant improvements over placebo regarding responder rates or bowel frequency in the studied population 8.

AI synthesis of 6 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Microbiota-immune-enteric nervous system interactions provide a framework for understanding functional and slow-transit constipation
Gastroenterology Sys. Review
Microbiota-immune-enteric nervous system interactions provide a framework for understanding functional and slow-transit constipation New Framework Explores Gut Bacteria Links to Chronic Constipation
This narrative review explores the complex interplay between the microbiome, immune system, and enteric nervous system in patients with func…
A new conceptual model explores how gut bacteria, the immune system, and nerves may interact to cause chronic constipation.
Frontiers Jul 3, 2026
Resting-state fMRI shows brain activity differences in women with functional constipation and stress urinary incontinence
Neurology Cohort
Resting-state fMRI shows brain activity differences in women with functional constipation and stress urinary incontinence Does stress incontinence and constipation change how your brain works?
A cohort study of 34 female patients with functional constipation and stress urinary incontinence (FCon-SUI), 24 with functional constipatio…
Women with both constipation and incontinence show unique brain activity patterns linked to movement control and visual processing that diff…
Frontiers Apr 14, 2026
Pelvic floor physiotherapy improves quality of life and reduces painful defecation in pediatric functional constipation
Pediatrics Meta-analysis
Pelvic floor physiotherapy improves quality of life and reduces painful defecation in pediatric functional constipation When Laxatives Are Not Enough, This Therapy May Help Kids
This meta-analysis of seven randomized controlled trials involving 775 pediatric and adolescent participants assessed pelvic floor physiothe…
For children whose constipation will not budge on laxatives alone, targeted pelvic floor therapy eased pain and boosted quality of life acro…
Apr 13, 2026
Network meta-analysis suggests Chinese patent medicines plus Western medicine may improve functional constipation in elderly
Infectious Disease Meta-analysis
Network meta-analysis suggests Chinese patent medicines plus Western medicine may improve functional constipation in elderly Chinese herbal medicines combined with Western drugs may help elderly constipation
A network meta-analysis of 23 RCTs involving 2065 elderly patients with functional constipation found that six Chinese patent medicines comb…
Adding specific Chinese herbal medicines to standard Western drugs may improve overall treatment response for elderly constipation, though e…
Frontiers Apr 2, 2026

Questions about Functional Constipation

Are there brain activity differences between women with functional constipation and stress urinary incontinence?

Women with functional constipation and stress urinary incontinence show different brain activity patterns compared to those with constipation alone, particularly in areas controlling movement and emotion.

Full answer →
Does pelvic floor physiotherapy reduce painful defecation in pediatric functional constipation patients?

Pelvic floor physiotherapy reduces painful defecation and improves quality of life in children with functional constipation, though results on how often they poop are mixed.

Full answer →
Does resting-state fMRI show brain activity differences in women with functional constipation?

Resting-state fMRI shows that women with functional constipation have different brain activity patterns compared to healthy people, and these patterns differ further if they also have stress urinary incontinence.

Full answer →