What side effects are associated with this type of intervention?

Common treatments for Irritable Bowel Syndrome (IBS) that modulate gut microbiota, such as prebiotics, probiotics, and synbiotics, can cause mild gastrointestinal symptoms. These include increased gas, bloating, and abdominal discomfort, particularly when first introduced. These side effects are generally mild and tend to resolve as the body adjusts to the changes in gut flora.

What prior FDA approvals exist?

The FDA has approved several treatments for Irritable Bowel Syndrome (IBS) that focus on modulating gut microbiota and improving gut health. Notably, rifaximin, an antibiotic, is approved for IBS with diarrhea (IBS-D) and works by altering the gut microbiota. Additionally, probiotics like Lactobacillus reuteri have been studied for their potential benefits in managing IBS symptoms by improving gut health, although they are not specifically FDA-approved for IBS. These treatments aim to alleviate symptoms by targeting the gut microbiome, similar to the approach being studied with Human Milk Oligosaccharides (HMOs).

What other types of research exist?

Promising alternatives to Human Milk Oligosaccharide mix for IBS treatment include specific probiotic strains like Lactobacillus reuteri, prebiotics such as fructo-oligosaccharides (FOS) and galacto-oligosaccharides (GOS), and synbiotics that combine both probiotics and prebiotics. Dietary modifications and fiber-enriched formulas are also potential options.

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Carbohydrate-based agent

HMO Supplement for Irritable Bowel Syndrome (HIBS Trial)

N/A

Waitlist Available

Led By Elizabeth Lowden, M.D.

Research Sponsored by DSM Nutritional Products, Inc.

Eligibility Criteria Checklist

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

Must have

Reported IBS diagnosis from a physician

Male or female aged ≥18 years at the time of consent

Must not have

Hepatic dysfunction or renal impairment

Treatment with an investigational drug from another clinical trial within 30 days/5 half-lives of the drug prior to screening visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (visit 2) to week 4 (call 1), to week 8 (call 2), and to week 12 (visit 3)

Summary

This trial is testing a mix of special sugars found in human breast milk to see if it can help people with moderate to severe IBS. The goal is to improve stool consistency and reduce abdominal pain. Participants will take the HMO mix once daily for a few months. Human milk oligosaccharides (HMOs) have been studied for their potential to normalize bowel habits and improve IBS symptoms.

Who is the study for?

Adults aged 18+ with IBS-D, IBS-C, or IBS-M as per Rome IV criteria can join this trial. They must have a physician's diagnosis of IBS, experience specific stool consistency and abdominal pain levels, and be able to use an electronic diary. Women of childbearing potential must agree to effective contraception.

What is being tested?

The trial is testing the effects of a Human Milk Oligosaccharide mix versus placebo on stool consistency and abdominal pain in people with Irritable Bowel Syndrome over 12 weeks. Participants will take their assigned treatment daily.

What are the potential side effects?

While not explicitly listed for HMOs, possible side effects may include digestive discomfort or allergic reactions. Placebos typically have no active ingredients but can cause perceived side effects due to the placebo effect.

Eligibility Criteria

Inclusion Criteria

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

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My doctor has diagnosed me with IBS.

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I am 18 years old or older.

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I have been diagnosed with a type of Irritable Bowel Syndrome.

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I can follow the trial rules and keep an electronic diary for 12 out of 14 days.

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My stool is mostly hard or watery, happening twice a week.

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My worst stomach pain averages over 3.3 in the last 2 weeks.

Exclusion Criteria

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

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I have liver or kidney problems.

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I haven't taken any experimental drugs in the last 30 days or 5 half-lives.

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I have had pancreatitis before.

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I am not taking any medications that are not allowed in this study.

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I have been diagnosed and treated for IBS for over 10 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (visit 2) to week 4 (call 1), to week 8 (call 2), and to week 12 (visit 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (visit 2) to week 4 (call 1), to week 8 (call 2), and to week 12 (visit 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (visit 2) to week 4 (call 1), to week 8 (call 2), and to week 12 (visit 3) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Absolute change in the pain severity score (IBS-SSS) in the active product compared to placebo group.

Absolute change in the proportion of stools with abnormal fecal consistency in the active product compared to placebo group.

Secondary study objectives

Absolute change in total IBS Quality of Life (IBS-QOL) score in the active product compared to placebo group.

Absolute change in total IBS severity score in the active product compared to placebo group.

Relative change in abundance of fecal Bifidobacteria spp in the active product compared to placebo group.

Other study objectives

Abdominal pain responder rate.

Absolute change in BIPQ score.

Absolute change in BSFS (Bristol Stool Form Scale) score.

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Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Human Milk Oligosaccharide (HMO) mixExperimental Treatment1 Intervention

The HMO blend to be used in this trial is a mix of the three milk oligosaccharides produced by fermentation of lactose. The blend is provided as white powder and mixed in a single serve stick packs containing 5.5 g of HMOs. The final product contains less than 0.03 g lactose per serving. The participants will be instructed to mix the product in a 4-6 oz glass of water and consume in the morning once a day for 12 weeks.

Group II: PlaceboPlacebo Group1 Intervention

The placebo to be used in this trial is 5.5 g of powdered dextrose powder in a single-serve stick pack. The participants will be instructed to mix the product in a 4-6 oz glass of water and consume in the morning once a day for 12 weeks.

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 Irritable Bowel Syndrome (IBS) often target the gut microbiota and overall gut health. Probiotics, such as Lactobacillus and Bifidobacterium species, are used to restore a healthy balance of gut bacteria, which can reduce symptoms like bloating and abdominal pain. Prebiotics, including certain fibers and oligosaccharides like HMOs, serve as food for beneficial bacteria, promoting their growth and activity. This can enhance gut barrier function and reduce inflammation. Additionally, dietary modifications like the low FODMAP diet aim to reduce fermentable carbohydrates that can exacerbate IBS symptoms. These treatments are crucial for IBS patients as they address the underlying dysbiosis and gut dysfunction, potentially leading to more sustainable symptom relief and improved quality of life.