Plecanatide for Constipation

(Trulance Trial)

This trial aims to determine if plecanatide, a medication, can treat functional constipation in children and teens. Researchers seek to discover whether plecanatide increases the number of natural bowel movements and improves symptoms over eight weeks compared to a placebo. Participants will receive either a low or high dose of plecanatide or a placebo and must keep a diary of their symptoms and bathroom visits. This trial suits children and teens who have struggled with constipation and have fewer than three spontaneous bowel movements per week. As a Phase 2 trial, the research focuses on assessing plecanatide's effectiveness in an initial, smaller group of young patients.

Yes, you will need to stop taking certain medications like anticholinergics, 5-HT agents, opioids, and other laxatives at least 15 days before starting the trial.

Previous studies have shown that plecanatide is generally well-tolerated in adults. The most common side effect reported was diarrhea. In one study, 5.9% of people taking plecanatide experienced diarrhea, compared to 1.3% of those taking a placebo (a pill with no active medicine). Severe diarrhea was rare, occurring in only 0.6% of cases. Researchers have found no new safety concerns in different groups of people. The FDA has already approved plecanatide for treating Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C) in adults, indicating a proven safety record for these conditions.¹²³⁴⁵

Most treatments for constipation, like fiber supplements, osmotic laxatives, or stimulant laxatives, address symptoms by drawing water into the intestines or stimulating bowel movements mechanically. But plecanatide works differently. It mimics a natural hormone in the body called uroguanylin, which helps regulate fluid secretion in the gut and enhances bowel movements more naturally. Researchers are excited because plecanatide offers a more physiological approach, potentially leading to fewer side effects and a more comfortable experience for patients. Plus, it's taken orally once a day, making it a convenient option for those struggling with constipation.

Research has shown that plecanatide can help adults with chronic constipation and irritable bowel syndrome with constipation (IBS-C) by increasing bowel movement frequency and improving stool consistency. In clinical trials, 21–48% of participants taking plecanatide experienced more complete bowel movements, compared to only 10–35% of those on a placebo. Plecanatide also reduced symptoms like stomach pain and bloating. Participants have tolerated it well, with side effects similar to those of a placebo. This trial will evaluate both low-dose and high-dose plecanatide, as well as a placebo, to determine its effectiveness for treating constipation-related symptoms in children and teens.⁶⁷⁸⁹¹⁰