Irritable Bowel SyndromeNCT04598529
Impact of A2 Milk Versus Conventional Milk on Intestinal Health: a Proof-of-concept Study in IBS-patients
A study testing A2 milk and Conventional milk in people with Irritable Bowel Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
This aim of this study is to evaluate the acute and mid-term effects of A2 milk versus conventional milk on gastrointestinal symptoms in patients with constipation-predominant IBS and in patients with diarrhea-predominant IBS. Moreover, the effect of immune and defense markers will be studied. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- A2 milk and Conventional milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Aug 2022to 5 Jun 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS with constipation (IBS-C) or IBS with diarrhea (IBS-D), based on the Rome IV criteria
- Self-reported indication that dietary components (e.g. milk) trigger GI symptoms
- Body Mass Index (BMI) < 30 kg/m2
- Weight-stable for at least 90 days prior to participation (no change in bodyweight, i.e. < 3kg).
- Willing to be informed in case of unexpected findings.
Who cannot join
- History of any disease or surgery interfering with the study aims, limiting participating or completing the study protocol
- Self-admitted human immunodeficiency virus-positive state.
- Disease with a life expectancy shorter than 5 years.
- Abdominal surgery interfering with gastrointestinal function (to be decided by a medical doctor)
- Based on anamnesis, patients with lactose intolerance will be excluded. If not tested before, a lactose breath test can be performed to check for lactose intolerance.
- Self reported cow's milk allergy
Show all 14Show fewer
- Use of antibiotics within 30 days prior to the study
- Use of other medication interfering with study outcomes, as will be reviewed by a medical doctor, who will decide on in- or exclusion based on the drug(s) used
- Administration of probiotic or prebiotic supplements, investigational drugs or participation in any scientific intervention study, which may interfere with this study (to be decided by the principle investigator), in the 14 days prior to the study
- Known pregnancy or lactation
- Plan to loose weight or follow a specific diet within the study period
- Alcohol intake: female >7 units/week for females, male >14 units/week
- Blood donation within 1 month prior to the study
- Insufficient fluency of the Dutch language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of A2 Milk Versus Conventional Milk on Intestinal Health: a Proof-of-concept Study in Irritable Bowel Syndrome Patients
This aim of this study is to evaluate the acute and mid-term effects of A2 milk versus conventional milk on gastrointestinal symptoms in patients with constipation-predominant IBS and in patients with diarrhea-predominant IBS. Moreover, the effect of immune and defense markers will be studied.
Read the detailed description
Irritable bowel syndrome (IBS) is a prevalent functional bowel disorder in which recurrent abdominal pain is associated with defecation and altered bowel habits. Although the pathophysiology is incompletely understood, it is generally regarded as a multifactorial disorder involving host factors such as low-grade immune activation, altered intestinal barrier function and defense. Environmental factors, including diet, are also suggested to play a role. Dairy products such as cow's milk are widely produced and an important component of the human diet. Cow's milk is composed of various macronutrients, micronutrients and water. Beta-casein is a major protein component of cow's milk; most cows produce a mixture of A1 and A2 beta-casein (conventional milk), whereas some cows produce only A2 beta-casein (A2 milk). It has been suggested that specific components in cow's milk, such as A1 beta-casein, may trigger gastrointestinal symptoms after intake.
The purpose of this randomized, double-blind, cross-over study performed in Maastricht University Medical Center (MUMC+) is to explore the acute and mid-terms effects of A2 milk versus conventional milk on gastrointestinal symptoms and immune and defense markers in separate groups of patient with constipation-predominant IBS and in patients with diarrhea-predominant IBS.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- A2 milk, Conventional milk
- Keywords
- Irritable Bowel Syndrome, IBS-C, IBS-D, Conventional milk, A2 milk, Gastrointestinal symptoms
- 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.
A2 milkOther
a variety of cow's milk that contains only A2 beta-casein (and therefore lacks of A1 beta-casein).
Conventional milkOther
cow's milk with a mixture of A1 and A2 beta-casein.
| Study group | Role | What they receive |
|---|---|---|
| A2 milk | Active comparator | A2 milk, organic, 200ml, twice daily Receives: Other: A2 milk |
| Conventional milk | Placebo comparator | Pasteurized semi-skimmed milk, organic, 200ml, twice daily Receives: Other: Conventional milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
The acute effects of A2 milk versus conventional milk on overall gastrointestinal discomfort in separate groups of individuals with IBS-C and IBS-D.
Assessed by a single item using a visual analogue scale (VAS), anchored at the low end (score of 0) with the absence of overall symptoms and at the other end (score of 100) with severe symptoms, the worst it has ever been.
Measured: On the 1 day intervention period
Secondary outcomes (4)
The mid-term effects of A2 milk versus conventional milk on overall gastrointestinal discomfort in separate groups of individuals with IBS-C and IBS-D.
Assessed by a single item using a visual analogue scale (VAS), anchored at the low end (score of 0) with the absence of overall symptoms and at the other end (score of 100) with severe symptoms, the worst it has ever been.
Measured: up to 3 days (once daily) after 1 day of intervention
The acute and mid-term effects of A2 milk versus conventional milk on single gastrointestinal symptoms and stool characteristics in separate groups of individuals with IBS-C and IBS-D.
Assessed by a visual analogue scale (VAS) for different gastrointestinal symptoms, anchored at the low end (score of 0) with the absence of overall symptoms and at the other end (score of 100) with severe symptoms, the worst it has ever been.
Measured: Multiple times at the 1 day intervention day and once daily up to 3 days after intervention day
The mid-term effects of A2 milk versus conventional milk on single gastrointestinal symptoms and stool characteristics in separate groups of individuals with IBS-C and IBS-D.
Assessed by the IBS-SSS questionnaire (a 0-100 scale, with the total IBS-SSS score ranging between 0 and 500, with higher scores indicating more severe symptoms).
Measured: At the first intervention day
The mid-term effects of A2 milk versus conventional milk on gastrointestinal immune and defense markers in separate groups of individuals with IBS-C and IBS-D.
Assessed by several parameters of GI immune and defense in feces.
Measured: At both intervention days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start8 Aug 2022
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
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.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D.M.A.E. Jonkers, Prof. Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598529
- Sponsor's protocol ID
- NL73898.068.20
- Other IDs
- METC 20-032
- Status last verified
- Jan 2024
- First submitted
- 6 Oct 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, we do not anticipate on sharing data outside MUMC+. If this changes in the future, we will submit an amendment.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of A2 Milk Versus Conventional Milk on Intestinal Health: a Proof-of-concept Study in Irritable Bowel Syndrome Patients
- ClinicalTrials.gov ID
- NCT04598529
- Acronym / sponsor ID
- NL73898.068.20
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, IBS-C, IBS-D, Conventional milk, A2 milk, Gastrointestinal symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 22 Oct 2020 (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.
This aim of this study is to evaluate the acute and mid-term effects of A2 milk versus conventional milk on gastrointestinal symptoms in patients with constipation-predominant IBS and in patients with diarrhea-predominant IBS. Moreover, the effect of immune and defense markers will be studied.
Detailed description
Irritable bowel syndrome (IBS) is a prevalent functional bowel disorder in which recurrent abdominal pain is associated with defecation and altered bowel habits. Although the pathophysiology is incompletely understood, it is generally regarded as a multifactorial disorder involving host factors such as low-grade immune activation, altered intestinal barrier function and defense. Environmental factors, including diet, are also suggested to play a role. Dairy products such as cow's milk are widely produced and an important component of the human diet. Cow's milk is composed of various macronutrients, micronutrients and water. Beta-casein is a major protein component of cow's milk; most cows produce a mixture of A1 and A2 beta-casein (conventional milk), whereas some cows produce only A2 beta-casein (A2 milk). It has been suggested that specific components in cow's milk, such as A1 beta-casein, may trigger gastrointestinal symptoms after intake.
The purpose of this randomized, double-blind, cross-over study performed in Maastricht University Medical Center (MUMC+) is to explore the acute and mid-terms effects of A2 milk versus conventional milk on gastrointestinal symptoms and immune and defense markers in separate groups of patient with constipation-predominant IBS and in patients with diarrhea-predominant IBS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A2 milk | Active comparator | Other: A2 milkA2 milk, organic, 200ml, twice daily |
| Conventional milk | Placebo comparator | Other: Conventional milkPasteurized semi-skimmed milk, organic, 200ml, twice daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- IBS with constipation (IBS-C) or IBS with diarrhea (IBS-D), based on the Rome IV criteria
- Self-reported indication that dietary components (e.g. milk) trigger GI symptoms
- Body Mass Index (BMI) < 30 kg/m2
- Weight-stable for at least 90 days prior to participation (no change in bodyweight, i.e. < 3kg).
- Willing to be informed in case of unexpected findings.
Key exclusion criteria (14 listed)
- History of any disease or surgery interfering with the study aims, limiting participating or completing the study protocol
- Self-admitted human immunodeficiency virus-positive state.
- Disease with a life expectancy shorter than 5 years.
- Abdominal surgery interfering with gastrointestinal function (to be decided by a medical doctor)
- Based on anamnesis, patients with lactose intolerance will be excluded. If not tested before, a lactose breath test can be performed to check for lactose intolerance.
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 |
|---|---|---|
| A2 milka variety of cow's milk that contains only A2 beta-casein (and therefore lacks of A1 beta-casein). | Other | A2 milk |
| Conventional milkcow's milk with a mixture of A1 and A2 beta-casein. | Other | Conventional milk |
Primary outcome
The acute effects of A2 milk versus conventional milk on overall gastrointestinal discomfort in separate groups of individuals with IBS-C and IBS-D.
Time frame: On the 1 day intervention period
Assessed by a single item using a visual analogue scale (VAS), anchored at the low end (score of 0) with the absence of overall symptoms and at the other end (score of 100) with severe symptoms, the worst it has ever been.
4 secondary outcomes
The mid-term effects of A2 milk versus conventional milk on overall gastrointestinal discomfort in separate groups of individuals with IBS-C and IBS-D.
Time frame: up to 3 days (once daily) after 1 day of intervention
The acute and mid-term effects of A2 milk versus conventional milk on single gastrointestinal symptoms and stool characteristics in separate groups of individuals with IBS-C and IBS-D.
Time frame: Multiple times at the 1 day intervention day and once daily up to 3 days after intervention day
The mid-term effects of A2 milk versus conventional milk on single gastrointestinal symptoms and stool characteristics in separate groups of individuals with IBS-C and IBS-D.
Time frame: At the first intervention day
The mid-term effects of A2 milk versus conventional milk on gastrointestinal immune and defense markers in separate groups of individuals with IBS-C and IBS-D.
Time frame: At both intervention days
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 5 Jan 2024.
- Individual participant dataSharing planned: No. Currently, we do not anticipate on sharing data outside MUMC+. If this changes in the future, we will submit an amendment.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
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Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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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.
D.M.A.E. Jonkers, Prof. Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A2 milk and Conventional milk in people with Irritable Bowel Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 14 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 5 Jan 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 Netherlands. 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 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?
The acute effects of A2 milk versus conventional milk on overall gastrointestinal discomfort in separate groups of individuals with IBS-C and IBS-D. (time frame: On the 1 day intervention period). 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 5 Jan 2024.