116 Participants Needed
Children's Hospital Medical Center, Cincinnati logo

2'-FL Supplement for Inflammatory Bowel Disease

(PRIME Trial)

Recruiting in Columbus (<10 mi)
+2 other locations
RB
Overseen ByRamona Bezold, BSN
Age: < 65
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Children's Hospital Medical Center, Cincinnati
Must be taking: Anti-TNF therapy

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests 2'-FL, a sugar from breast milk, as a dietary supplement for young IBD patients in stable remission. It aims to boost good gut bacteria and improve gut health by increasing butyrate levels. 2'-FL, a human milk oligosaccharide, has been shown to promote the growth of beneficial gut bacteria and improve gut health in various studies.

Will I have to stop taking my current medications?

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.

Is 2'-FL safe for human consumption?

2'-Fucosyllactose (2'-FL) is considered safe for human consumption under the proposed conditions of use, as it is similar to natural components found in human milk. The European Food Safety Authority (EFSA) has evaluated its safety and found no concerns when used in foods and supplements, with intake levels comparable to those in breastfed infants.12345

How does the 2'-FL treatment differ from other treatments for inflammatory bowel disease?

The 2'-FL treatment is unique because it is a prebiotic oligosaccharide found in human milk that promotes the growth of beneficial gut bacteria and increases short-chain fatty acids like butyrate, which can improve gut health. Unlike traditional treatments that may focus on reducing inflammation directly, 2'-FL works by enhancing the gut microbiome, potentially leading to improved gastrointestinal symptoms and quality of life in patients with conditions like ulcerative colitis.16789

What data supports the effectiveness of the treatment 2'-Fucosyllactose for Inflammatory Bowel Disease?

Research shows that 2'-Fucosyllactose, a compound found in human milk, can help improve gut health by strengthening the intestinal barrier and reducing inflammation. Studies in mice with colitis, a type of inflammatory bowel disease, found that 2'-Fucosyllactose helped maintain body weight, protect colon length, and lower inflammation markers, suggesting it may be beneficial for similar conditions in humans.12101112

Are You a Good Fit for This Trial?

This trial is for young people aged 11-25 with Crohn's Disease or Ulcerative Colitis in remission, not on steroids, and taking stable anti-TNF therapy like adalimumab or infliximab. Participants must consent to the study rules and can't be pregnant, breastfeeding, have had recent surgery (except one ileo-colic resection), or been on certain medications.

Inclusion Criteria

Agreement to not make any major dietary changes throughout study duration. This would include changing usual diet to a vegan diet, Specific Carbohydrate Diet (SCD), or exclusive enteral nutrition (EEN) diet.
My child's Crohn's disease is mild.
I am 18-25 years old with mild Crohn's disease symptoms.
See 11 more

Exclusion Criteria

I do not have celiac disease, diabetes, or any other condition that the study leader would exclude.
Currently pregnant or breast feeding
I have lactose intolerance.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2'-FL or dextrose placebo as a daily dietary supplement

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 2'-Fucosyllactose
Trial Overview The study tests if a dietary supplement called 2'-Fucosyllactose (2'-FL) at doses of 1, 5, or 10 grams daily is safe and improves gut health compared to a placebo in those with IBD. It's randomized so participants don't choose which treatment they get.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 2'-FucosyllactoseExperimental Treatment1 Intervention
Phase I: 36 young adult participants aged 18-25 years. Group 1: 1 gm per day n=12 (6UC/6CD) Group 2: 5 gm per day n=12 (6UC/6CD) Group 3: 10 gm per day n=12 (6UC/6CD) Phase II (post Phase I interim safety analysis): 120 participants aged 11-25 years Group 1: 1 gm per day n=40 (20UC/20CD) Group 2: 5 gm per day n=40 (20UC/20CD) Group 3: 10 gm per day n=40 (20UC/20CD)
Group II: PlaceboPlacebo Group1 Intervention
Phase I: 20 young adult participants age 18-25 years dosed at 2 gm placebo per day. (10UC/10CD) Phase II (post Phase I interim safety analysis): 40 participants age 11-25 years dosed at 2 gm placebo per day. (20UC/20CD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Nationwide Children's Hospital

Collaborator

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354
Recruited
5,228,000+

Broad Institute of MIT and Harvard

Collaborator

Trials
21
Recruited
16,300+

Broad Institute

Collaborator

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21
Recruited
16,300+

University of Cincinnati

Collaborator

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442
Recruited
639,000+

Connecticut Children's Medical Center

Collaborator

Trials
76
Recruited
30,000+

Published Research Related to This Trial

2'-Fucosyllactose (2'-FL), a sugar found in human milk, was shown to protect small intestinal epithelial cells from damage caused by the chemotherapy drug 5-fluorouracil (5-FU), reducing cell apoptosis and inflammation in mouse models.
Pretreatment with 2'-FL significantly improved outcomes in mice with 5-FU-induced intestinal mucositis, including less body weight loss and reduced intestinal damage, compared to concurrent treatment, highlighting its potential as a preventive therapy.
2'-Fucosyllactose Ameliorates Chemotherapy-Induced Intestinal Mucositis by Protecting Intestinal Epithelial Cells Against Apoptosis.Zhao, G., Williams, J., Washington, MK., et al.[2022]
In a study involving 64 Wistar rats, supplementation with soluble fiber or fructooligosaccharides (FOS) prior to TNBS-induced colitis did not significantly improve colon health or reverse lesions after 14 days.
While FOS supplementation was associated with an increased colon weight/length ratio, neither treatment showed any beneficial effects on body weight or colon lesions, indicating that these supplements may not be effective in managing TNBS-induced colitis.
Effect of soluble fiber or fructooligosaccharide supplementation upon trinitrobenzenesulphonic acid induced colitis in rats.Murad-Regadas, SM., Souza, MH., Brito, GA., et al.[2019]
Supplementation with blends of Human Milk Oligosaccharides (HMOs) can enhance intestinal barrier function, particularly in the presence of inflammatory challenges, as shown in vitro using Caco-2: HT29 cell line monolayers.
The six-HMO blend (HMO6) was particularly effective in reducing harmful translocation of substances and improving barrier integrity, indicating that specific combinations of HMOs could be beneficial for gut health and protection against inflammatory diseases.
Blends of Human Milk Oligosaccharides Confer Intestinal Epithelial Barrier Protection in Vitro.Natividad, JM., Rytz, A., Keddani, S., et al.[2021]

Citations

2'-Fucosyllactose Ameliorates Chemotherapy-Induced Intestinal Mucositis by Protecting Intestinal Epithelial Cells Against Apoptosis. [2022]
Effect of soluble fiber or fructooligosaccharide supplementation upon trinitrobenzenesulphonic acid induced colitis in rats. [2019]
Blends of Human Milk Oligosaccharides Confer Intestinal Epithelial Barrier Protection in Vitro. [2021]
Is a low FODMAP diet beneficial for patients with inflammatory bowel disease? A meta-analysis and systematic review. [2019]
2'-Fucosyllactose and 3-Fucosyllactose Alleviates Interleukin-6-Induced Barrier Dysfunction and Dextran Sodium Sulfate-Induced Colitis by Improving Intestinal Barrier Function and Modulating the Intestinal Microbiome. [2023]
Safety of 2'-fucosyllactose (2'-FL) produced by a derivative strain (Escherichia coli&#160;SGR5) of E. coli W (ATCC 9637) as a Novel Food pursuant to Regulation (EU) 2015/2283. [2023]
Safety of 3-fucosyllactose (3-FL) produced by a derivative strain of Escherichia coli K-12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283. [2023]
Safety of 2'-fucosyllactose (2'-FL) produced by a derivative strain (APC199) of Corynebacterium glutamicumATCC 13032 as a novel food pursuant to Regulation (EU) 2015/2283. [2022]
Improved production of 2'-fucosyllactose in engineered Saccharomyces cerevisiae expressing a putative α-1, 2-fucosyltransferase from Bacillus cereus. [2021]
Whole cell biosynthesis of a functional oligosaccharide, 2'-fucosyllactose, using engineered Escherichia coli. [2021]
Metabolic Fate and Distribution of 2´-Fucosyllactose: Direct Influence on Gut Microbial Activity but not on Brain. [2023]
Impact of 2'-Fucosyllactose on Gut Microbiota Composition in Adults with Chronic Gastrointestinal Conditions: Batch Culture Fermentation Model and Pilot Clinical Trial Findings. [2021]
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