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Impact of A2 Milk Versus Conventional Milk on Intestinal Health: a Proof-of-concept Study in IBS-patients

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
A2 milk
Conventional milk
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, IBS-C, IBS-D, Conventional milk, A2 milk, Gastrointestinal symptoms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Maastricht UMC+Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A2 milk

Conventional milk

Arm Description

A2 milk, organic, 200ml, twice daily

Pasteurized semi-skimmed milk, organic, 200ml, twice daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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.
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 blood.

Full Information

First Posted
October 6, 2020
Last Updated
September 27, 2022
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04598529
Brief Title
Impact of A2 Milk Versus Conventional Milk on Intestinal Health: a Proof-of-concept Study in IBS-patients
Official Title
Impact of A2 Milk Versus Conventional Milk on Intestinal Health: a Proof-of-concept Study in Irritable Bowel Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, IBS-C, IBS-D, Conventional milk, A2 milk, Gastrointestinal symptoms

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A2 milk
Arm Type
Active Comparator
Arm Description
A2 milk, organic, 200ml, twice daily
Arm Title
Conventional milk
Arm Type
Placebo Comparator
Arm Description
Pasteurized semi-skimmed milk, organic, 200ml, twice daily
Intervention Type
Other
Intervention Name(s)
A2 milk
Intervention Description
a variety of cow's milk that contains only A2 beta-casein (and therefore lacks of A1 beta-casein).
Intervention Type
Other
Intervention Name(s)
Conventional milk
Intervention Description
cow's milk with a mixture of A1 and A2 beta-casein.
Primary Outcome Measure Information:
Title
The acute effects of A2 milk versus conventional milk on overall gastrointestinal discomfort in separate groups of individuals with IBS-C and IBS-D.
Description
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.
Time Frame
day 1 of each intervention period
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
up to 14 days (once daily) of each intervention period
Title
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.
Description
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.
Time Frame
multiple times at day 1 and once daily at day 2-14 of each intervention period
Title
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.
Description
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).
Time Frame
day 1 and 14 of each intervention period
Title
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.
Description
Assessed by several parameters of GI immune and defense in feces.
Time Frame
day 1 and 14 of each intervention period
Title
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.
Description
Assessed by several parameters of GI immune and defense in blood.
Time Frame
day 1 and 14 of each intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Bosman, MD
Phone
+31(0)433884291
Email
m.bosman@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D.M.A.E. Jonkers, Prof. Dr.
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht UMC+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Bosman, MD
Phone
+31(0)433884291
Email
m.bosman@maastrichtuniversity.nl

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently, we do not anticipate on sharing data outside MUMC+. If this changes in the future, we will submit an amendment.

Learn more about this trial

Impact of A2 Milk Versus Conventional Milk on Intestinal Health: a Proof-of-concept Study in IBS-patients

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