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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 belowSelect...
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 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)
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 moreHIBS 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor has diagnosed me with IBS.I have liver or kidney problems.I am 18 years old or older.I am not pregnant and agree to use birth control during the study.I haven't taken any experimental drugs in the last 30 days or 5 half-lives.I have had pancreatitis before.I have no stomach or bowel diseases that could affect the study.I am not taking any medications that are not allowed in this study.I am not pregnant, can use birth control, and will do so during the trial.I haven't taken antibiotics, prebiotics, probiotics, or fiber supplements recently.I have not had surgery on my stomach, small intestine, or colon in the last year.I have long-term health conditions that affect my daily life.I have been diagnosed with a type of Irritable Bowel Syndrome.I have been diagnosed and treated for IBS for over 10 years.I can follow the trial rules and keep an electronic diary for 12 out of 14 days.My stool is mostly hard or watery, happening twice a week.My worst stomach pain averages over 3.3 in the last 2 weeks.My doctor has diagnosed me with IBS.My pain is often linked to changes in how often I go to the bathroom.You have access to the internet via a personal computer, tablet, or smartphone.
Research Study Groups:
This trial has the following groups:- Group 1: Human Milk Oligosaccharide (HMO) mix
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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:
- Atlantia Clinical Trials Ltd: < 48 hours
Typically responds via
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