Irritable Bowel Syndrome (IBS)Phase 2NCT02875847
Effects of HMOs on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in IBS Patients
A Phase 2 study testing HMO1, HMO2 and Dextropur in people with Irritable Bowel Syndrome (IBS), run by Glycom A/S at 1 site in Sweden.
Trial summary
The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients. A total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria will be included. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- HMO1, HMO2 and Dextropur
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2016to Jul 2018
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Age between 18 and 75 years at visit 2
- Fulfills definition of IBS-D, IBS-C or IBS-A/M according to Rome IV criteria
- Have a global IBS-SSS score of >174 during the 2 weeks run-in period
- Read, speak and understand Swedish
- Ability and willingness to understand and comply with the study procedures
Who cannot join
- Participation in a clinical intervention trial one month prior to screening visit and throughout the study.
- Any known gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator; in particular
- lactose intolerance
- coeliac disease
- Other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
- Severe psychiatric disease and/or psychological disturbance, as judged by the investigator.
Show all 12Show fewer
- Use of highly dosed probiotic supplements (yoghurt allowed) one month prior to the study and throughout the study. Excluded products are (i) probiotic supplements in the form of capsules, tablets, and powders in sachets, and (ii) probiotic food and drink products which contain high doses of probiotics. The excluded food and drink products are available in the form of yoghurts, drinking yoghurts, shots and drinks under brands such as Proviva, Actimel, Activia, Wellness, and Verum.
- Consumption of antibiotic drugs one month prior to screening and throughout the study. Antibiotic use within the last three months prior to screening will be registered.
- Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) two weeks prior to screening and throughout the study. Specifically excluded drugs are opioids, NSAIDs on a weekly basis, regular use of laxatives and anti-diarrhoeal drugs, any drugs indicated for IBS symptoms.
- Diagnosed with and treated for IBS for more than 10 years
- Pregnant or lactating or wish to become pregnant during the period of the study.
- Lack of suitability for participation in the study for any reason as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
SU Sahlgrenska, Department of Internal Medicine
Gothenburg, SE-413 35
About this study
Official title: The Effects of Human Milk Oligosaccharides on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in Irritable Bowel Syndrome: a Parellell, Double-blind, Randomised, Placebo-controlled Study
The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients. A total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria will be included. The participants will be randomized into one of three groups consuming either HMO (two groups) or placebo (one group).
The primary objective of the study is to establish the effect of HMOs on the faecal microbiota in IBS patients. Secondary objectives are to assess the effect on gastrointestinal symptoms, mucosal immunity, gut barrier function, quality of life, and anxiety and depression.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- HMO1, HMO2, Dextropur
- 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.
HMO1Dietary supplement
HMO2Dietary supplement
DextropurDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| HMO1 | Active comparator | Daily bolus of HMO1 Receives: Dietary Supplement: HMO1 |
| HMO2 | Active comparator | Daily bolus of HMO2 Receives: Dietary Supplement: HMO2 |
| Dextropur | Placebo comparator | Daily bolus of dextropur Receives: Dietary Supplement: Dextropur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in intestinal bifidobacteria abundance
Measured: Baseline and after 4 weeks of intake
Secondary outcomes (13)
Change from baseline of faecal microbiota profile
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of IBS symptoms as measured via the total score on the IBS Symptoms Severity Scale (IBS-SSS) and the proportion of responders in all patients and subgroup of patients
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of intensity of abdominal pain and number of days of abdominal pain as measured on the 11 point Numeric Rating Scale (NRS-11) in all patients and subgroups of patients
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of bowel habits as measured via the IBS-SSS, the Bristol Stool Form Scale (BSFS) and a bowel movement diary in all patients and subgroup of patients
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of abdominal distention as measured via the IBS-SSS in all patients and subgroups of patients
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale for IBS patients (GSRS-IBS) in all patients and subgroup of patients
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of quality of life in IBS patients as measured by the IBS-QOL in all patients and subgroups of patients
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of anxiety and depression as measured by the Hospital Anxiety and Depression Scales (HADS) in all patients and subgroups of patients
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of gastrointestinal symptom specific anxiety as measured by the Visceral Sensitivity Index (VSI) in all patients and subgroup of patients
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of severity of somatic symptoms as measured by the Patient Health Questionnaire-15 (PHQ-15) in all patients and subgroup of patients
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of biomarkers of inflammation in all patients and subgroups of patients
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of biomarkers of gut barrier function in all patients and subgroups of patients
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of biomarkers of the gut-brain axis in all patients and subgroups of patients
Measured: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome (IBS)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glycom A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Magnus Simrén, MD, PhD, Principal investigator, Department of Internal MedicineHans Törnblom, MD, PhD, Principal investigator, Department of Internal MedicineLena Öhman, PhD, Principal investigator, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875847
- Sponsor's protocol ID
- NATRIBS
- Other IDs
- Dnr: 548-16
- Status last verified
- Sep 2018
- First submitted
- 12 Aug 2016
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Iribarren C, Tornblom H, Aziz I, Magnusson MK, Sundin J, Vigsnaes LK, Amundsen ID, McConnell B, Seitzberg D, Ohman L, Simren M. Human milk oligosaccharide supplementation in irritable bowel syndrome patients: A parallel, randomized, double-blind, placebo-controlled study. Neurogastroenterol Motil. 2020 Oct;32(10):e13920. doi: 10.1111/nmo.13920. Epub 2020 Jun 14.
PubMed 32536023
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Human Milk Oligosaccharides on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in Irritable Bowel Syndrome: a Parellell, Double-blind, Randomised, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02875847
- Acronym / sponsor ID
- NATRIBS
- Conditions
- Irritable Bowel Syndrome (IBS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Glycom A/SIndustry (pharma, biotech, devices)
- Collaborators
- Sahlgrenska University Hospital
- Study start
- Sep 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 23 Aug 2016 (estimated)
- 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.
The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients. A total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria will be included. The participants will be randomized into one of three groups consuming either HMO (two groups) or placebo (one group).
The primary objective of the study is to establish the effect of HMOs on the faecal microbiota in IBS patients. Secondary objectives are to assess the effect on gastrointestinal symptoms, mucosal immunity, gut barrier function, quality of life, and anxiety and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HMO1 | Active comparator | Dietary Supplement: HMO1Daily bolus of HMO1 |
| HMO2 | Active comparator | Dietary Supplement: HMO2Daily bolus of HMO2 |
| Dextropur | Placebo comparator | Dietary Supplement: DextropurDaily bolus of dextropur |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written informed consent
- Age between 18 and 75 years at visit 2
- Fulfills definition of IBS-D, IBS-C or IBS-A/M according to Rome IV criteria
- Have a global IBS-SSS score of >174 during the 2 weeks run-in period
- Read, speak and understand Swedish
Key exclusion criteria (12 listed)
- Participation in a clinical intervention trial one month prior to screening visit and throughout the study.
- Any known gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator; in particular
- Other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
- Severe psychiatric disease and/or psychological disturbance, as judged by the investigator.
- Use of highly dosed probiotic supplements (yoghurt allowed) one month prior to the study and throughout the study. Excluded products are (i) probiotic supplements in the form of capsules, tablets, and powders in sachets, and (ii) probiotic food and drink products which contain high doses of probiotics. The excluded food and drink products are available in the form of yoghurts, drinking yoghurts, shots and drinks under brands such as Proviva, Actimel, Activia, Wellness, and Verum.
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 |
|---|---|---|
| HMO1 | Dietary supplement | HMO1 |
| HMO2 | Dietary supplement | HMO2 |
| Dextropur | Dietary supplement | Dextropur |
Primary outcome
Change from baseline in intestinal bifidobacteria abundance
Time frame: Baseline and after 4 weeks of intake
13 secondary outcomes
Change from baseline of faecal microbiota profile
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of IBS symptoms as measured via the total score on the IBS Symptoms Severity Scale (IBS-SSS) and the proportion of responders in all patients and subgroup of patients
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of intensity of abdominal pain and number of days of abdominal pain as measured on the 11 point Numeric Rating Scale (NRS-11) in all patients and subgroups of patients
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of bowel habits as measured via the IBS-SSS, the Bristol Stool Form Scale (BSFS) and a bowel movement diary in all patients and subgroup of patients
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of abdominal distention as measured via the IBS-SSS in all patients and subgroups of patients
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale for IBS patients (GSRS-IBS) in all patients and subgroup of patients
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of quality of life in IBS patients as measured by the IBS-QOL in all patients and subgroups of patients
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of anxiety and depression as measured by the Hospital Anxiety and Depression Scales (HADS) in all patients and subgroups of patients
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of gastrointestinal symptom specific anxiety as measured by the Visceral Sensitivity Index (VSI) in all patients and subgroup of patients
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of severity of somatic symptoms as measured by the Patient Health Questionnaire-15 (PHQ-15) in all patients and subgroup of patients
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of biomarkers of inflammation in all patients and subgroups of patients
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of biomarkers of gut barrier function in all patients and subgroups of patients
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Change from baseline of biomarkers of the gut-brain axis in all patients and subgroups of patients
Time frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Derived from this study: PubMed 32536023Iribarren C, Tornblom H, Aziz I, Magnusson MK, Sundin J, Vigsnaes LK, Amundsen ID, McConnell B, Seitzberg D, Ohman L, Simren M. Human milk oligosaccharide supplementation in irritable bowel syndrome patients: A parallel, randomized, double-blind, placebo-controlled study. Neurogastroenterol Motil. 2020 Oct;32(10):e13920. doi: 10.1111/nmo.13920. Epub 2020 Jun 14.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome (IBS)
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Magnus Simrén, MD, PhD principal investigator
Department of Internal Medicine
Hans Törnblom, MD, PhD principal investigator
Department of Internal Medicine
Lena Öhman, PhD principal investigator
Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HMO1, HMO2 and Dextropur in people with Irritable Bowel Syndrome (IBS), run by Glycom A/S at 1 site in Sweden.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 24 Sep 2018. 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 Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in intestinal bifidobacteria abundance (time frame: Baseline and after 4 weeks of intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02875847, which also lists 1 linked publication.
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 24 Sep 2018.