Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04598529
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2020-10-06
Brief Title:
Impact of A2 Milk Versus Conventional Milk on Intestinal Health a Proof-of-concept Study in IBS-patients
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Impact of A2 Milk Versus Conventional Milk on Intestinal Health a Proof-of-concept Study in Irritable Bowel Syndrome Patients
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cows milk are widely produced and an important component of the human diet Cows milk is composed of various macronutrients micronutrients and water Beta-casein is a major protein component of cows 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 cows 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| METC 20-032 | OTHER | Medical Ethical Committee | None |