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Carbohydrate-based agent

HMO Supplement for Irritable Bowel Syndrome (HIBS Trial)

N/A
Recruiting
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
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)
Awards & highlights

HIBS Trial Summary

This triallooks at the effect of a dietary supplement on IBS symptoms: stool consistency, abdominal pain.

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.Check my eligibility
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.See study design
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.

HIBS Trial 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.

HIBS Trial 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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
Abdominal pain responder rate.
Absolute change in BIPQ score.
Absolute change in BSFS (Bristol Stool Form Scale) score.
+17 more

HIBS 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.

Find a Location

Who is running the clinical trial?

DSM Nutritional Products, Inc.Lead Sponsor
93 Previous Clinical Trials
56,779 Total Patients Enrolled
Seema Mody, MScStudy DirectorDSM
Elizabeth Lowden, M.D.Principal InvestigatorAtlantia Clinical Trials

Media Library

Human Milk Oligosaccharide Mix (Carbohydrate-based agent) Clinical Trial Eligibility Overview. Trial Name: NCT05205785 — N/A
Irritable Bowel Syndrome Research Study Groups: Human Milk Oligosaccharide (HMO) mix, Placebo
Irritable Bowel Syndrome Clinical Trial 2023: Human Milk Oligosaccharide Mix Highlights & Side Effects. Trial Name: NCT05205785 — N/A
Human Milk Oligosaccharide Mix (Carbohydrate-based agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05205785 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Missouri
Indiana
How old are they?
18 - 65
What site did they apply to?
Atlantia Clinical Trials Ltd
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Atlantia Clinical Trials Ltd: < 48 hours
Typically responds via
Email
~250 spots leftby Mar 2025