Effects of A2 Dairy Consumption in Celiac Adolescents

NCT07815821 | Completed

• 1 other identifier: 125S700
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effect of A2 β-casein-containing milk and dairy product consumption on nutritional status, gastrointestinal symptoms, quality of life, sleep quality, and selected biochemical parameters in adolescents aged 10-18 years with celiac disease. The main questions it aims to answer are:

• Does consumption of A2 β-casein-containing milk and dairy products improve gastrointestinal symptoms and quality of life in adolescents with celiac disease?
• Does consumption of A2 β-casein-containing milk and dairy products affect nutritional status, body composition, and biochemical parameters compared with standard milk and dairy products? Researchers will compare adolescents consuming A2 β-casein-containing milk and dairy products with adolescents consuming standard milk and dairy products to see if A2 β-casein provides additional benefits. Participants will:
• Consume the assigned milk and dairy products during the intervention period.
• Attend baseline and follow-up assessments.
• Complete dietary records and questionnaires related to gastrointestinal symptoms, sleep quality, and quality of life.
• Undergo anthropometric, body composition, hand grip strength, and biochemical assessments.

Conditions

Celiac Disease; Celiac Disease in Children; A2 β-casein-containing Milk and Dairy Products

Outcome Measures

Primary Outcomes (15)

• Change From Baseline in Celiac Disease-Specific Quality of Life Total Score at Week 8

  Celiac disease-specific quality of life will be assessed using the Celiac Disease Dutch Questionnaire (CDDUX). The total score ranges from 0 to 100, with higher scores indicating better quality of life.

  Baseline and Week 8

• Change From Baseline in Celiac Symptom Index Total Score at Week 8

  Gastrointestinal symptoms will be assessed using the Celiac Symptom Index (CSI). The CSI total score ranges from 16 to 80, with higher scores indicating more severe celiac disease-related symptoms.

  Baseline and 8 weeks

• Change From Baseline in Anti-tTG IgA Level at Week 8

  Serum anti-tissue transglutaminase immunoglobulin A (anti-tTG IgA) level will be measured and reported as RU/mL to assess the change from baseline to Week 8.

  Baseline and Week 8

• Change From Baseline in Anti-tTG IgG Level at Week 8

  Serum anti-tissue transglutaminase immunoglobulin G (anti-tTG IgG) level will be measured and reported as RU/mL to assess the change from baseline to Week 8.

  Baseline and Week 8

• Change From Baseline in Leukocyte Count at Week 8

  Leukocyte count will be measured in blood samples and reported as 10⁹/L to assess the change from baseline to Week 8.

  Baseline and Week 8

• Change From Baseline in Neutrophil Count at Week 8

  Absolute neutrophil count will be measured in blood samples and reported as 10⁹/L to assess the change from baseline to Week 8.

  Baseline and Week 8

• Change From Baseline in Neutrophil-to-Lymphocyte Ratio at Week 8

  The neutrophil-to-lymphocyte ratio (NLR) will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. NLR will be reported as a unitless ratio to assess the change from baseline to Week 8.

  Baseline and Week 8

• Change From Baseline in Serum Albumin Level at Week 8

  Serum albumin level will be measured and reported as g/L to assess the change from baseline to Week 8.

  Baseline and Week 8

• Change From Baseline in Serum Total Protein Level at Week 8

  Serum total protein level will be measured and reported as g/L to assess the change from baseline to Week 8.

  Baseline and Week 8

• Change From Baseline in Serum Alanine Aminotransferase Level at Week 8

  Serum alanine aminotransferase (ALT) level will be measured and reported as U/L to assess the change from baseline to Week 8.

  Baseline and Week 8

• Change From Baseline in Serum Aspartate Aminotransferase Level at Week 8

  Serum aspartate aminotransferase (AST) level will be measured and reported as U/L to assess the change from baseline to Week 8.

  Baseline and Week 8

• Change From Baseline in Serum Ferritin Level at Week 8

  Serum ferritin level will be measured and reported as µg/L to assess the change from baseline to Week 8.

  Baseline and Week 8

• Change From Baseline in Serum Folate Level at Week 8

  Serum folate level will be measured and reported as µg/L to assess the change from baseline to Week 8.

  Baseline and Week 8

• Change From Baseline in Serum Vitamin B12 Level at Week 8

  Serum vitamin B12 level will be measured and reported as ng/L to assess the change from baseline to Week 8.

  Baseline and Week 8

• Change From Baseline in Serum Calcium Level at Week 8

  Serum calcium level will be measured and reported as mg/dL to assess the change from baseline to Week 8.

  Baseline and Week 8

Secondary Outcomes (17)

• Change From Baseline in Body Weight at Week 8

  Baseline and Week 8

• Change From Baseline in Height at Week 8

  Baseline and Week 8

• Change From Baseline in Body Mass Index at Week 8

  Baseline and Week 8

• Change From Baseline in BMI-for-Age Z Score at Week 8

  Baseline and Week 8

• Change From Baseline in Height-for-Age Z Score at Week 8

  Baseline and Week 8

Study Arms (2)

A2 β-casein-containing milk and dairy products

EXPERIMENTAL

Participants assigned to this group consumed milk and dairy products containing A2 β-casein during the intervention period.

Dietary Supplement: A2 β-casein milk and dairy products

Standard milk and dairy products group

ACTIVE COMPARATOR

Participants assigned to this group consumed standard milk and dairy products containing conventional β-casein during the intervention period.

Dietary Supplement: Standard milk and dairy products

Interventions

A2 β-casein milk and dairy products DIETARY_SUPPLEMENT

Participants consumed milk and dairy products containing A2 β-casein during the 8-week intervention period.

A2 β-casein-containing milk and dairy products

Standard milk and dairy products DIETARY_SUPPLEMENT

Participants consumed standard milk and dairy products during the 8-week intervention period.

Standard milk and dairy products group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents aged 10-18 years
• Diagnosis of celiac disease according to ESPGHAN criteria
• Being diagnosed with celiac disease within the last 3 months
• Volunteering to participate in the study

You may not qualify if:

• Presence of any chronic disease other than celiac disease
• Presence of lactose intolerance
• Presence of cow's milk protein allergy

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

Sariyer Hamidiye Etfal Training and Research Hospital

Istanbul, 34421, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Dairy Products

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: September 11, 2026
• Study Start: February 1, 2022
• Primary Completion: June 1, 2026
• Study Completion: July 3, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

TU (1)