What side effects are associated with this type of intervention?

Common treatments for IBS that modulate gut microbiota, such as prebiotics, probiotics, and synbiotics, generally have a good safety profile with few side effects. However, some individuals may experience gastrointestinal symptoms like bloating, gas, and abdominal discomfort. Fiber supplements can also cause bloating and gas, especially when first introduced. Antidiarrheals like loperamide may lead to constipation and should be used cautiously. Bile acid sequestrants can cause gastrointestinal side effects including bloating, flatulence, abdominal discomfort, and constipation.

What prior FDA approvals exist?

The FDA has approved several treatments for Irritable Bowel Syndrome (IBS), including medications like alosetron (Lotronex) for IBS-D (diarrhea-predominant IBS) and linaclotide (Linzess) for IBS-C (constipation-predominant IBS). These treatments primarily target symptom relief through mechanisms such as serotonin receptor antagonism and increasing intestinal fluid secretion. While specific FDA-approved treatments focusing on gut microbiota modulation, like the 2'-FL-containing dietary supplement, are not mentioned, probiotics and dietary modifications such as the low FODMAP diet are commonly recommended to manage IBS symptoms by altering gut microbiota composition.

What other types of research exist?

Promising alternatives to 2'-FL-containing dietary supplements for IBS patients include: 1) Probiotic mix VSL#3, which has shown symptom improvement in IBS patients. 2) Fecal microbiota transplantation (FMT), particularly for patients with recurrent Clostridioides difficile infection, which may also benefit IBS patients. 3) Prebiotic oligosaccharides, such as short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides, which have been shown to positively impact gut microbiota and reduce inflammation. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Prebiotic

2'-Fucosyllactose Supplement for Irritable Bowel Syndrome

N/A

Recruiting

Led By Ryan Bradley, ND, MPH

Research Sponsored by National University of Natural Medicine

Eligibility Criteria Checklist

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

Must have

Adults age 18-70 years (inclusive)

Willing to refrain from making changes in dietary supplements and medications for the duration of the study

Must not have

History of gastrointestinal surgery other than appendectomy (e.g. weight loss surgery, cholecystectomy, splenectomy, etc.)

Current or previous history of chronic gastrointestinal illness other than IBS (e.g. inflammatory bowel disease, celiac disease, diverticulitis, cirrhosis, hepatitis, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Summary

This trial is testing a dietary supplement containing 2'-FL in adults with IBS. The goal is to see if it can improve gut health by increasing good bacteria. Researchers will measure changes in specific gut bacteria to determine its effectiveness.

Who is the study for?

Adults aged 18-70 with IBS, able to consent and attend 4 visits, who speak English. They must not change their diet, exercise, or medications during the study and be willing to take a supplement thrice daily for 6 weeks. Excluded are those with recent cancer (except certain skin cancers), no active IBS management by a healthcare provider, recent medication changes or use of antibiotics/antifungals, major dietary program participants, significant GI surgery history other than appendectomy.

What is being tested?

The trial tests if a dietary supplement containing 2'-fucosyllactose affects gut bacteria in adults with IBS. Participants will either receive this supplement or a placebo while researchers monitor changes in specific beneficial gut bacteria and overall microbial diversity through stool sample analysis.

What are the potential side effects?

Potential side effects aren't specified but may include typical reactions to supplements such as digestive discomfort or allergic reactions to any ingredient listed like Collinsonia root or beet root.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 70 years old.

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I agree not to change my medications or supplements during the study.

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I have been diagnosed with IBS.

Exclusion Criteria

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

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I have had surgery on my digestive system, not including appendix removal.

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I have a history of chronic gastrointestinal illness other than IBS.

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I am not pregnant, breastfeeding, or planning to become pregnant soon.

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I haven't been hospitalized for a major event in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

F. Prausnitzii abundance

Secondary study objectives

Alpha diversity of the microbiota

Beta diversity of the microbiota

Bifidobacterium spp. relative abundance

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Investigational supplementExperimental Treatment1 Intervention

Participants in this arm will take a supplement containing 2'-fucosyllactose (2'-FL)

Group II: Placebo supplementPlacebo Group1 Intervention

Participants in this arm will take a placebo supplement

0 / 7Eligibility 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 Irritable Bowel Syndrome (IBS) often aim to modulate the gut microbiota composition, as an imbalance in gut bacteria is believed to play a role in IBS symptoms. For instance, 2'-FL-containing dietary supplements are designed to increase the abundance of beneficial bacteria like Faecalibacterium prausnitzii, which can improve gut health and reduce inflammation. Probiotics and prebiotics are also used to enhance the growth of beneficial bacteria and improve microbial diversity. Additionally, antibiotics like rifaximin target and reduce harmful bacteria, potentially alleviating symptoms like bloating and diarrhea. These treatments matter for IBS patients because they address the underlying microbial imbalances that contribute to the condition, potentially leading to more effective and long-lasting symptom relief.

Efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome: A double-blind, randomized, placebo-controlled trial.