2'-FL Supplement for Inflammatory Bowel Disease

(PRIME Trial)

This trial tests a new supplement, 2'-Fucosyllactose, for individuals with inflammatory bowel diseases such as Crohn's Disease and ulcerative colitis. Researchers aim to determine if this supplement is safe and can increase beneficial gut bacteria and butyrate, a compound that may enhance gut health. Participants will receive either the supplement or a placebo (a non-active substance) daily while maintaining their current treatments. The trial seeks individuals aged 11-25 who are in stable remission from Crohn's or ulcerative colitis and are on consistent anti-TNF therapy, such as infliximab or adalimumab. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

The trial requires that you stay on a stable dose of your current anti-TNF medication (like adalimumab or infliximab) for at least 12 weeks before joining. If you're taking mesalamine, mercaptopurine, azathioprine, or methotrexate, you must also be on a stable dose for 12 weeks before starting the trial. You cannot use antibiotics, probiotics, prebiotics, or anti-diarrheal medications during the trial.

Research has shown that 2'-fucosyllactose (2'-FL) is generally safe and easy for the body to handle. Studies have found that it can help reduce inflammation in conditions like inflammatory bowel disease (IBD). One study found it safe for preterm infants, indicating its gentleness on the body. Another study confirmed that 2'-FL is well-tolerated in people and does not cause major side effects.

Unlike the standard treatments for Inflammatory Bowel Disease, such as anti-inflammatory drugs, immunosuppressants, and biologics, 2'-Fucosyllactose (2'-FL) is unique because it is a naturally occurring human milk oligosaccharide. Researchers are excited about 2'-FL because it works differently, potentially modulating the gut microbiota and strengthening the gut barrier, which could reduce inflammation in a more natural way. This new mechanism of action offers the promise of fewer side effects compared to traditional therapies, which often suppress the immune system and can lead to complications. By targeting the gut environment itself, 2'-FL could offer a novel approach to managing symptoms and improving the quality of life for patients with conditions like ulcerative colitis and Crohn's disease.

Studies have shown that 2'-Fucosyllactose (2'-FL) might benefit individuals with inflammatory bowel disease (IBD), including Crohn's Disease and ulcerative colitis. Research indicates that 2'-FL can enhance gut health by aiding the recovery of the intestinal mucosal barrier, which serves as a protective wall for the gut. It also helps reduce inflammation, a major issue in IBD. Some studies suggest that 2'-FL promotes a healthier gut microbiota, the community of tiny organisms living in the gut. Early findings from animal studies showed that 2'-FL can ease symptoms of colitis, a common problem in IBD. These promising results suggest that 2'-FL might help manage IBD symptoms more effectively. In this trial, participants will receive either 2'-FL or a placebo to evaluate its effectiveness in managing IBD symptoms.¹⁴⁵⁶⁷