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

NCT04598529 | Completed DMC

• 2 other identifiers: NL73898.068.20METC 20-032
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; IBS-C; IBS-D; Conventional milk; A2 milk; Gastrointestinal symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  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.

  At both intervention days

Study Arms (2)

A2 milk

ACTIVE COMPARATOR

A2 milk, organic, 200ml, twice daily

Other: A2 milk

Conventional milk

PLACEBO COMPARATOR

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

Other: Conventional milk

Interventions

A2 milk OTHER

a variety of cow's milk that contains only A2 beta-casein (and therefore lacks of A1 beta-casein).

A2 milk

Conventional milk OTHER

cow's milk with a mixture of A1 and A2 beta-casein.

Conventional milk

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC+

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• D.M.A.E. Jonkers, Prof. Dr.

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 22, 2020
• Study Start: August 8, 2022
• Primary Completion: June 5, 2023
• Study Completion: June 5, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)