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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 weeks

Awards & highlights

PRIME Trial Summary

This trial is testing whether a supplement called 2'-FL is safe and effective in treating inflammatory bowel diseases like Crohn's Disease and ulcerative colitis. 1, 5, or 10 gm of 2'-FL will be given daily compared to a placebo to see if it increases the abundance of good bacteria and butyrate in the gut.

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.Check my eligibility

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.See study design

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.

PRIME Trial 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.

PRIME Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Glucose

PRIME 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)

0 / 8Eligibility 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.