None listed
Conditions
Brief summary
This open-label, single-centre pilot clinical trial aims to evaluate the effects of daily supplementation with 2'-Fucosyllactose (2'-FL), a human milk oligosaccharide (HMO) prebiotic, in adults with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and in healthy adults. HMOs are a unique class of bioactive glycans naturally present in human breast milk, with 2'-fucosyllactose (2'-FL) being the most abundant (Thurl et al. 2017; Suligoj et al. 2020; Fanous et al. 2025). All participants will receive 20 grams of 2'-FL once daily for 12 weeks. Stool samples will be collected at baseline, midpoint, end of supplementation, and after a 4-week washout period to assess changes in gut microbiome composition and microbial metabolites. Blood samples will be collected at baseline (week 0), end of the supplementation (week 12), and washout (week 16) to assess systemic inflammatory biomarkers. Gastrointestinal symptoms will be assessed using participant-reported questionnaires at baseline and at the end of the supplementation. Participant adherence and safety will be monitored throughout the study. We hypothesise that daily supplementation with 2'-fucosyllactose will improve gut microbiome composition, reduce inflammation, and alleviate gastrointestinal symptoms in adults with inflammatory bowel disease, with effects that may persist after supplementation. The major questions it aims to answer are: • Can 2’-FL improve symptoms for patients living with moderately active IBD? • Can 2’-FL improve the gut microbiome composition, microbial metabolites, and anti-inflammatory immune markers in IBD patients? • Are the microbiome and anti-inflammatory effects of 2'-FL sustained beyond the supplementation period? • Does 2'-FL produce similar effects on the gut microbiome and immune biomarkers in healthy adults without known bowel disease?
Interventions
This is an open-label, single-centre pilot clinical trial conducted at Macquarie University Hospital (MUH), Sydney, Australia.
All participants, including patients with Crohn’s disease, ulcerative colitis, and healthy adults, will receive 2'-Fucosyllactose (2'-FL), a food-grade human milk oligosaccharide prebiotic approved by the Therapeutic Goods Administration (TGA) for use in dietary supplements and infant formula in Australia. Pure 2'-FL will be obtained either from Layer Origin Nutrition (
This is an open-label, single-centre pilot clinical trial conducted at Macquarie University Hospital (MUH), Sydney, Australia. All participants, including patients with Crohn’s disease, ulcerative colitis, and healthy adults, will receive 2'-Fucosyllactose (2'-FL), a food-grade human milk oligosaccharide prebiotic approved by the Therapeutic Goods Administration (TGA) for use in dietary supplements and infant formula in Australia. Pure 2'-FL will be obtained either from Layer Origin Nutrition (USA) or Intrinsic Medicine (USA) which is can be stored at room temperature. The intervention consists of oral supplementation with 2'-FL powder at a dose of 20 grams per day, consumed once daily for 12 weeks. Participants will consume the supplement by mixing the powder with their usual food or preferred beverages. Following completion of the 12-week supplementation period, participants will enter a 4-week washout period with no 2'-FL intake. Participants with inflammatory bowel disease will continue their routine clinical care and usual diet during the study period. Adherence will be monitored using participant-reported intake via REDCap surveys, return of empty sachets, and regular follow-up contact.
Sponsors
Macquarie University Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
• Adults aged 18-65 years • Confirmed diagnosis of mild to moderate UC (Mayo score 2-10) or CD (Crohn’s Disease Activity Index; CDAI score 150 to <250) confirmed with supportive clinical, endoscopic, and histopathological evidence (receiving routine management for IBD with no planned major treatment changes for next 6 months) • Healthy adults (n=15) with no known major food allergy and no health issues • Able and willing to provide informed written consent and comply with all study procedures and availability for the duration of the study • Agreement to not make any major dietary changes throughout study duration such as usual diet to a vegan diet, or exclusive enteral nutrition (EEN) diet
Exclusion criteria
• Patients with acute severe colitis, as defined by the Truelove and Witts criteria • Pregnant or breastfeeding or planning pregnancy during the study period • Any clinically significant infection <4 weeks prior to enrolment • Evidence of or treatment for Clostridioides difficile (C. difficile) or Helicobacter pylori • Initiation or discontinuation of systemic IBD therapy such as immunomodulator or advanced therapy (biologic) within the last 12 weeks • Other active gastrointestinal inflammatory diseases (e.g., uncontrolled coeliac disease, infectious colitis) • Presence of complications from IBD such as short gut syndrome, stricture, perianal abscess • Current diagnosis or suspicion of primary sclerosing cholangitis • Use of corticosteroids within preceding 6 weeks or during trial period • Major recent gastrointestinal surgery or anticipated surgery in the near term • Known immunodeficiency or other medical/psychiatric conditions that could interfere with participation • Known major food allergy
Outcome results
None listed