In short
Currently, there are 4 clinical trials investigating treatments for constipation. These studies focus on different age groups and types of constipation, testing medications such as polyethylene glycol with electrolytes, linaclotide, and naloxegol. The trials are being conducted across several European countries including Spain, the Netherlands, Bulgaria, Croatia, Germany, Hungary, and Belgium.
Clinical trial locations
- Belgium
- Bulgaria
- Croatia
- Germany
- Hungary
- Netherlands
- Spain
Study on Preventing Constipation in Critically Ill Children Using Macrogol 3350, Sodium Hydrogen Carbonate, Potassium Chloride, and Sodium Chloride
This trial is evaluating whether a combination medication called Movicol Pediátrico Sabor Neutro can prevent constipation in critically ill children admitted to Pediatric Intensive Care Units. The medication contains polyethylene glycol with electrolytes, which works by holding water in the stool to make it softer and easier to pass.
Who can participate: Children between 1 month and 16 years old who are expected to stay in the PICU for more than 3 days and are at high risk of developing constipation, as determined by a special scoring system. Parents or legal guardians must provide consent, and children aged 12 to 16 must also agree to participate.
Who cannot participate: Children who are not critically ill, not at risk of constipation, outside the specified age range, have medical conditions that might interfere with the study, are taking medications that could affect results, have allergies to the study medication, or are participating in another clinical trial.
What the study measures: The main focus is on assessing stool output to determine if the treatment effectively prevents constipation. The study also monitors for any adverse events and evaluates stool consistency using the Bristol scale. The trial is expected to continue until December 2025.
Study on Linaclotide for Treating Functional Constipation in Children Aged 2 to 5 Years
This study is testing linaclotide, a medication that works by increasing fluid in the intestines to help soften stools. The trial aims to evaluate both the effectiveness and long-term safety of this treatment for functional constipation in young children.
Who can participate: Children aged 2 to 5 years and 11 months who meet specific criteria for functional constipation, including having 2 or fewer bowel movements per week for at least one month. Children should not have significant health issues that could interfere with the study. Caregivers must agree to stop using other laxatives and use only the study-approved rescue medicine, and children must average 2 or fewer spontaneous bowel movements per week during a 14-day observation period.
Who cannot participate: Children who do not have functional constipation, do not meet the Rome IV diagnostic criteria for childhood constipation, are outside the specified age range, or have not completed previous related studies.
What the study involves: The trial has two parts. In the first 12-week period, children receive either linaclotide or a placebo, during which caregivers record bowel movement frequency, stool consistency, and any straining. In the second 24-week period, all participants receive linaclotide to assess its long-term safety.
Study on Linaclotide for Treating Functional Constipation in Children Aged 6 Months to Less Than 2 Years
This trial is investigating the appropriate dose of linaclotide for very young children with functional constipation. The medication helps increase fluid in the intestines and speeds up the movement of stools through the digestive system.
Who can participate: Infants and toddlers aged 6 months to less than 2 years who have a healthy weight-to-height ratio and meet specific criteria for functional constipation, including having 2 or fewer bowel movements per week without laxatives, a history of stool withholding, painful or hard bowel movements, or large stools. Based on a parent-kept diary, the child must have fewer than 2 spontaneous bowel movements per week during the 14 days before enrollment.
Who cannot participate: Children outside the specified age range, those without functional constipation, children with other medical conditions that might interfere with the study, those taking medications that could affect results, children who recently participated in another trial, those with allergies to the study medication, or those whose parents will not follow study procedures.
What the study measures: Over a 4-week period, researchers will monitor changes in bowel movement frequency, stool consistency, and straining to determine a safe and effective dose for this age group. The goal is to identify a treatment that can improve quality of life for young children with functional constipation.
Study on the Effects of Naloxegol and Codeine on Opioid-Induced Constipation in Healthy Volunteers
This trial is studying how naloxegol works to relieve opioid-induced constipation in healthy volunteers. Naloxegol blocks the effects of opioids in the gut, helping to restore normal bowel movements. The study also evaluates the effects of codeine, an opioid pain medication, and bisacodyl, a laxative, using MRI scans to observe changes in intestinal movement and size.
Who can participate: Healthy men and women aged 18 to 65 with a Body Mass Index between 18 and 25, who have normal bowel patterns (between 3 bowel movements per day and 3 per week). Participants must not have used opioid medications for at least 14 days before the study and must use highly effective birth control methods. Those taking stable doses of medications for allergies, chronic conditions, or migraines may participate, as well as those on stable doses of antidepressants for at least 3 months.
Who cannot participate: People who are not healthy volunteers, under 18 years old, pregnant or breastfeeding, have a history of allergic reactions to study medications, are taking medications that might interfere with the study, have significant medical conditions, recently participated in another trial, have a history of drug or alcohol abuse, or are unable to follow study procedures.
What the study involves: Participants will receive different combinations of medications including naloxegol with codeine, placebo with codeine, and placebo with placebo. Throughout the study, MRI scans will be used to monitor changes in the gastrointestinal tract after taking medications and eating meals, helping researchers understand how these medications affect the digestive system.
Summary
The four ongoing clinical trials for constipation address different patient populations and types of the condition. Three trials focus on pediatric functional constipation, testing linaclotide in various age groups from 6 months to 5 years, while one trial examines prevention in critically ill children using polyethylene glycol with electrolytes. A fourth trial investigates opioid-induced constipation in healthy adult volunteers using naloxegol.
There is notable geographic diversity in these trials, with Bulgaria participating in two studies and multiple countries across Europe contributing to the research. The concentration of pediatric trials reflects the importance of finding safe and effective treatments for constipation in children, a population that has historically had limited treatment options. The linaclotide studies are particularly comprehensive, covering a wide age range and including long-term safety evaluations.
