What side effects are associated with this type of intervention?

Common treatments for Inflammatory Bowel Disease (IBD) include prebiotics, probiotics, synbiotics, mesalamine, and sulfasalazine. Prebiotics and probiotics are generally well-tolerated but can cause mild gastrointestinal symptoms such as bloating and gas. Mesalamine and sulfasalazine, which are anti-inflammatory medications, can have side effects including nausea, headache, fever, rash, pancreatitis, and pneumonitis. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several treatments for Inflammatory Bowel Disease (IBD), including biologics like infliximab and adalimumab, which target specific components of the immune system to reduce inflammation. While there are no specific FDA-approved treatments that focus solely on prebiotic effects promoting Bifidobacterium and butyrate production, some studies and trials are exploring the potential benefits of such approaches. For instance, 2'-FL, a prebiotic, is being studied for its ability to increase fecal Bifidobacterium abundance and butyrate levels, which may offer a novel therapeutic avenue for IBD management.

What other types of research exist?

Promising novel alternatives to 2'-FL for IBD patients include germinated barley foodstuff (GBF), which modifies intestinal microflora and increases butyrate levels, and synbiotics, which combine probiotics and prebiotics to enhance gut health. Additionally, investigational antimicrobial agents like ridinilazole and specific probiotic strains such as Lactobacillus and Bifidobacterium species may offer beneficial effects.

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2'-FL Supplement for Inflammatory Bowel Disease (PRIME Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pediatric CD (age 11-17): wPCDAI < 12.5

Adult CD (age 18-25): CDAI score < 150

Must not have

Problem with lactose breakdown

We will exclude CD patients with more than one IBD related surgery, or those with a sub-total colectomy. We will exclude UC patients with colectomy or IBD related surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is testing a dietary supplement expected to improve gut bacteria levels safely, major side effects are not anticipated. However, any potential digestive discomfort will be monitored as part of the trial's safety assessment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child's Crohn's disease is mild.

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I am 18-25 years old with mild Crohn's disease symptoms.

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I have been diagnosed with Crohn's Disease or Ulcerative Colitis.

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I am between 11 and 25 years old.

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My condition is currently in remission.

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I am not taking corticosteroids.

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I am an adult with UC and currently have no blood in stool or increased stool frequency.

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I am aged 11-17 with mild ulcerative colitis symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have lactose intolerance.

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I have Crohn's disease but haven't had more than one surgery for it, and I don't have ulcerative colitis with any related surgery.

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I am not taking any anti-diarrheal medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Gastrointestinal Symptom Rating Scale (GSRS) in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo

Secondary study objectives

Glucose

Trial Design

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

2'-Fucosyllactose

2023

N/A

~60

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Inflammatory Bowel Disease (IBD) include anti-inflammatory drugs, immunosuppressants, biologics, and dietary interventions. Anti-inflammatory drugs like 5-aminosalicylic acids (5-ASA) reduce inflammation in the gut lining. Immunosuppressants and biologics target specific components of the immune system to prevent it from attacking the gastrointestinal tract. Prebiotics, such as 2'-FL, promote the growth of beneficial gut bacteria like Bifidobacterium, which in turn produce short-chain fatty acids like butyrate. Butyrate has anti-inflammatory properties and helps maintain the integrity of the gut lining. These mechanisms are crucial for IBD patients as they help reduce inflammation, promote gut health, and potentially induce and maintain remission.