Irritable Bowel SyndromeHIBSNCT05205785
Human Milk Oligosaccharides (HMOs) for Irritable Bowel Syndrome (IBS)
A study testing Human Milk Oligosaccharide Mix in people with Irritable Bowel Syndrome and IBS - Irritable Bowel Syndrome, run by dsm-firmenich Switzerland AG at 1 site in Ireland.
Trial summary
To assess the effects of a Human Milk Oligosaccharide mix given once daily for 12 weeks on stool consistency and abdominal pain compared to placebo in individuals with Irritable Bowel Syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, IBS - Irritable Bowel Syndrome
- What is being tested?
- Human Milk Oligosaccharide Mix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteIreland
- Study dates
- 22 Mar 2023to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained before any trial related assessments are performed.
- Male or female aged ≥18 years at the time of consent.
- Female participants of child-bearing potential (females who are post-menopausal, i.e., when there has been no menstruation for a minimum of 12 months prior to screening, are considered not to be of child-bearing potential.), who are not surgically sterilized, must have a negative pregnancy test at screening and be willing to practice one of the following appropriate contraceptive methods until the last visit: i. Sexual abstinence. ii. Oral contraceptives. iii. Trans dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to product administration). iv. Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent. v. Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration). vi. Contraceptives must be effective before the randomization visit. However, national requirements should always be followed.
- IBS-D or IBS-C or IBS-M according to Rome IV criteria. This will be established by using the IBS Module of the Rome IV Diagnostic Questionnaire, and requires recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with two or more of the following:
- Related to defecation (may be increased or unchanged by defecation) on at least 30% of pain instances in past 3 months.
- Associated with a change in stool frequency (on at least 30% of pain instances in past 3 months).
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- Associated with a change in stool form or appearance (on at least 30% of pain instances in past 3 months).
- Reported IBS diagnosis from a physician.
- Personal access to the internet via computer, tablet, or smart-phone.
- Be willing and able to comply with trial protocol, including entry of electronic diary data for at least 12 out of 14 diary days during the pre-randomization baseline 2-week run-in diary period (between V1 andV2).
- Inclusion criteria Visit 2: To be eligible for inclusion, the participant must fulfil all of the following criteria:
- Scores of 1, 2, 6, or 7 on the Bristol stool scale at least twice per week [as determined by eDiary completion between V1 and V2].
- An average baseline of worst abdominal pain of ≥3.3 (NRS-11) during the 2-week run-in period prior to randomization [as determined by eDiary completion between V1 and V2].
Who cannot join
- The presence of any of the following criteria will exclude the participant from participating in the trial:
- Treatment with an investigational drug from another clinical trial within 30 days/5 half- lives of the drug (which ever longest) prior to screening visit.
- Any known gastrointestinal disease(s) or medical history that may interfere with the trial evaluations in the opinion of the investigator, in particular:
- Coeliac disease.
- IBD.
- Diverticulitis.
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- C. difficile infection reported in the previous 2 years.
- Any clinically symptomatic biochemical or structural abnormality or active disease of the gastrointestinal tract within 6 months before screening, including daily diarrhea within two weeks prior to the screening interview or during the screening/baseline period.
- Substance abuse (within past 2 years).
- New use of antibiotics (within past 2 months), prebiotics, probiotics, or fiber supplements (within the past month).
- Hepatic dysfunction assessed as part of the blood safety panel (defined as alanine aminotransaminase/serum glutamic-pyruvic transaminase or aspartate aminotransaminase/serum glutamic-oxaloacetic transaminase >2.5 x the upper limit of normal, or a history of hepatobiliary disease) or renal impairment (serum creatinine) >2 mg/dl); any surgery (within a year of screening) on the stomach, small intestine, or colon (excluding appendectomy, hernia surgery not involving the GI tract, or c-section).
- Any history of pancreatitis (either acute or chronic).
- Laxative abuse (use of more than recommended dosage).
- Pregnant or lactating individuals.
- Any other gastrointestinal disease(s) or medical history that may interfere with the trial evaluations in the judgment of the investigator.
- Following strict diets to improve their IBS symptoms as judged by the investigator e.g., Low FODMAP (within past 2 months). Exclusion based on diet will be reviewed by single investigator for consistency.
- Any clinically relevant chronic disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease, autoimmune or neurological disease, that in the opinion of the investigator would interfere with the trial evaluations or the safety of the participant.
- Current severe psychiatric disease and/or psychological disturbance, a major psychiatric disorder requiring hospitalization in the last 3 years, or a history of attempted suicide or uncontrolled bipolar disorder; or clinical evidence of any significant psychiatric disease or symptoms that may interfere with the participant successfully completing the trial.
- Treatment with restricted and prohibited concomitant medications.
- Diagnosed with and treated for IBS for more than 10 years
- Has a business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial.
- Lack of suitability for participation in the study for any reason as judged by the investigator.
- Has previously been randomized into this trial, is participating in this trial at another investigational site or is planning to participate in any other clinical trial during this trial.
- Desire and/or plans on changing current diet regime during the participation of this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supporting Healthy Gastrointestinal Function With Human Milk Oligosaccharides (HMOs) in Individuals With Irritable Bowel Syndrome (IBS)
To assess the effects of a Human Milk Oligosaccharide mix given once daily for 12 weeks on stool consistency and abdominal pain compared to placebo in individuals with Irritable Bowel Syndrome (IBS).
Read the detailed description
HMO mix has been shown to provide therapeutic benefits to individuals with IBS of all subtypes (Palsson et al., 2019). DSM is planning this trial in order to investigate if clinically relevant improvements in bowel movements and IBS symptoms can be obtained through the use of the HMO mix in individuals with moderate to severe IBS and abdominal pain.
Eligible participants will have a diagnosis of Irritable Bowel Syndrome (IBS). Participants will be assessed for eligibility at the screening visit, must meet all the inclusion criteria, and none of the exclusion criteria.
In this trial, participants will be randomized to one of two intervention groups (a Human Milk Oligosaccharide mix or placebo) and receive intervention for at least 12 weeks.
- Being tested
- Human Milk Oligosaccharide Mix, Placebo
- Keywords
- Human Milk Oligosaccharides, HMOs
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Milk Oligosaccharide MixDietary supplement
Also called HMOs
Subjects takes 5.5 g of powder mixed in water once a day for 12 weeks.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Human Milk Oligosaccharide (HMO) mix | Experimental | 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. Receives: Dietary Supplement: Human Milk Oligosaccharide Mix |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in the proportion of stools with abnormal fecal consistency in the active product compared to placebo group.
Participants will identify each bowel movement 'type' using the Bristol Stool Scale (Type 1 = hard stool difficult to pass [classified as severe constipation]; Type 7 = watery, entirely liquid stool [classified as severe diarrhea]). Types 1 and 2 would be considered to suggest severe and mild diarrhea, respectively. Types 6 and 7 would be considered to suggest mild and severe diarrhea, respectively. This endpoint will compare the proportion of participants experiencing constipation and diarrhea between the groups
Measured: Baseline (2 week run in period) to end of intervention (weeks 11 + week 12)
Absolute change in the pain severity score (IBS-SSS) in the active product compared to placebo group.
The IBS Symptom Severity Scale (IBS-SSS) contains a pain subscale which asks participants to rate abdominal pain the past 10 days on a scale from 0 to 100, with 0 meaning "no pain" and 100 meaning "very severe pain". The minimum score is 0 and the maximum achievable score is 100.
Measured: Baseline (Visit 2) to Week 12 (Visit 3)
Secondary outcomes (3)
Absolute change in total IBS severity score in the active product compared to placebo group.
The IBS Symptom Severity Scale (IBS-SSS) contains 5 items. Each of the five questions generate a maximum score of 100 using prompted visual analogue scales. The minimum score is 0 and the maximum achievable score is 500.
Measured: Baseline (Visit 2) to Week 12 (Visit 3)
Absolute change in total IBS Quality of Life (IBS-QOL) score in the active product compared to placebo group.
The IBS Quality of Life contains 34 items each with a five-point response scale, where 1 represents not at all and 5 extremely/A great detail. The participant ill answer each question with respect to the impact of IBS and it's treatment. The individual responses to the 34 items are summed and averaged for a total score and transformed to a 0-100 scale for interpretation with higher scores indicating better IBS specific quality of life.
Measured: Baseline (Visit 2) to Week 12 (Visit 3)
Relative change in abundance of fecal Bifidobacteria spp in the active product compared to placebo group.
Relative change in abundance measured by gene sequencing analysis of fecal sample.
Measured: Baseline (Visit 2) to Week 12 (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start22 Mar 2023
- Primary completion5 Mar 2024
- Study completion24 Jun 2024
Why it stopped: Due to low enrollment, we have terminated this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Buckley, M.D., Principal investigator, Atlantia Clinical TrialsSeema Mody, MSc, Study director, DSM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205785
- Sponsor's protocol ID
- 2021-07-21-HMOS
- Acronym
- HIBS
- Status last verified
- Aug 2024
- First submitted
- 22 Dec 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Healthy Gastrointestinal Function With Human Milk Oligosaccharides (HMOs) in Individuals With Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT05205785
- Acronym / sponsor ID
- HIBS / 2021-07-21-HMOS
- Keywords
- Human Milk Oligosaccharides, HMOs
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low enrollment, we have terminated this study
- Enrolment
- 204 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effects of a Human Milk Oligosaccharide mix given once daily for 12 weeks on stool consistency and abdominal pain compared to placebo in individuals with Irritable Bowel Syndrome (IBS).
Detailed description
HMO mix has been shown to provide therapeutic benefits to individuals with IBS of all subtypes (Palsson et al., 2019). DSM is planning this trial in order to investigate if clinically relevant improvements in bowel movements and IBS symptoms can be obtained through the use of the HMO mix in individuals with moderate to severe IBS and abdominal pain.
Eligible participants will have a diagnosis of Irritable Bowel Syndrome (IBS). Participants will be assessed for eligibility at the screening visit, must meet all the inclusion criteria, and none of the exclusion criteria.
In this trial, participants will be randomized to one of two intervention groups (a Human Milk Oligosaccharide mix or placebo) and receive intervention for at least 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Milk Oligosaccharide (HMO) mix | Experimental | Dietary Supplement: Human Milk Oligosaccharide MixThe 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. |
| Placebo | Placebo comparator | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent obtained before any trial related assessments are performed.
- Male or female aged ≥18 years at the time of consent.
- IBS-D or IBS-C or IBS-M according to Rome IV criteria. This will be established by using the IBS Module of the Rome IV Diagnostic Questionnaire, and requires recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with two or more of the following:
- Reported IBS diagnosis from a physician.
- Personal access to the internet via computer, tablet, or smart-phone.
Key exclusion criteria (24 listed)
- The presence of any of the following criteria will exclude the participant from participating in the trial:
- Treatment with an investigational drug from another clinical trial within 30 days/5 half- lives of the drug (which ever longest) prior to screening visit.
- Any known gastrointestinal disease(s) or medical history that may interfere with the trial evaluations in the opinion of the investigator, in particular:
- Following strict diets to improve their IBS symptoms as judged by the investigator e.g., Low FODMAP (within past 2 months). Exclusion based on diet will be reviewed by single investigator for consistency.
- Any clinically relevant chronic disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease, autoimmune or neurological disease, that in the opinion of the investigator would interfere with the trial evaluations or the safety of the participant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Milk Oligosaccharide MixAlso: HMOsSubjects takes 5.5 g of powder mixed in water once a day for 12 weeks. | Dietary supplement | Human Milk Oligosaccharide (HMO) mix |
| PlaceboThe 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. | Other | Placebo |
Primary outcome
Absolute change in the proportion of stools with abnormal fecal consistency in the active product compared to placebo group.
Time frame: Baseline (2 week run in period) to end of intervention (weeks 11 + week 12)
Participants will identify each bowel movement 'type' using the Bristol Stool Scale (Type 1 = hard stool difficult to pass [classified as severe constipation]; Type 7 = watery, entirely liquid stool [classified as severe diarrhea]). Types 1 and 2 would be considered to suggest severe and mild diarrhea, respectively. Types 6 and 7 would be considered to suggest mild and severe diarrhea, respectively. This endpoint will compare the proportion of participants experiencing constipation and diarrhea between the groups
Absolute change in the pain severity score (IBS-SSS) in the active product compared to placebo group.
Time frame: Baseline (Visit 2) to Week 12 (Visit 3)
The IBS Symptom Severity Scale (IBS-SSS) contains a pain subscale which asks participants to rate abdominal pain the past 10 days on a scale from 0 to 100, with 0 meaning "no pain" and 100 meaning "very severe pain". The minimum score is 0 and the maximum achievable score is 100.
3 secondary outcomes
Absolute change in total IBS severity score in the active product compared to placebo group.
Time frame: Baseline (Visit 2) to Week 12 (Visit 3)
Absolute change in total IBS Quality of Life (IBS-QOL) score in the active product compared to placebo group.
Time frame: Baseline (Visit 2) to Week 12 (Visit 3)
Relative change in abundance of fecal Bifidobacteria spp in the active product compared to placebo group.
Time frame: Baseline (Visit 2) to Week 12 (Visit 3)
Results and safety
The study was stopped early (reason given: Due to low enrollment, we have terminated this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Buckley, M.D. principal investigator
Atlantia Clinical Trials
Seema Mody, MSc study director
DSM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Milk Oligosaccharide Mix in people with Irritable Bowel Syndrome and IBS - Irritable Bowel Syndrome, run by dsm-firmenich Switzerland AG at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to low enrollment, we have terminated this study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in the proportion of stools with abnormal fecal consistency in the active product compared to placebo group. (time frame: Baseline (2 week run in period) to end of intervention (weeks 11 + week 12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.