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

Phase

N/A

Condition

Colic

Lactose Intolerance

Gastrointestinal Diseases And Disorders

Treatment

Conventional milk

A2 milk

Clinical Study ID

NCT04598529

NL73898.068.20

METC 20-032

Ages 18-70
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

IBS with constipation (IBS-C) or IBS with diarrhea (IBS-D), based on the Rome IVcriteria
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

Exclusion Criteria:

History of any disease or surgery interfering with the study aims, limitingparticipating 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 amedical doctor)
Based on anamnesis, patients with lactose intolerance will be excluded. If not testedbefore, 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 amedical doctor, who will decide on in- or exclusion based on the drug(s) used
Administration of probiotic or prebiotic supplements, investigational drugs orparticipation in any scientific intervention study, which may interfere with thisstudy (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

Study Design

Conventional milk

August 08, 2022

June 05, 2023

Study 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.

Connect with a study center

Maastricht UMC+
Maastricht, Limburg 6229 HX
Netherlands
Site Not Available

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