Study on the influence of a dairy-free diet on pro- and anti-inflammatory immune responses and the integrity of the intestinal barrier in MS patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039900

Enrollment

Registered

2026-06-30

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G35

Interventions

Group 1: Following recruitment of participants, a baseline assessment (t0) is conducted, which includes recording the severity of MS using the EDSS, a questionnaire on dietary habits, a self-report on

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants over the age of 18 with a confirmed clinical diagnosis of MS who have previously consumed animal milk regularly and are willing and able to attend all study visits, adhere to a dairy-free dietary phase in accordance with the study protocol, and provide written informed consent. The MS diagnosis should have been made within the last 5 years, and the participant must not be receiving B-cell-depleting medication at the time of study participation.

Exclusion criteria

Exclusion criteria: Existing B-cell-depleting medication. Individuals following a vegan diet, or with confirmed lactose intolerance or confirmed gluten intolerance.

Design outcomes

Primary

Measure	Time frame
Determination of the influence of cow's milk consumption on pro- and anti-inflammatory immune responses in peripheral blood at study enrollment, as well as after 8 and 16 weeks of intervention. To this end, a detailed immunophenotyping of the adaptive and innate immune responses is performed using flow cytometry and cytokine/chemokine analysis.	—

Secondary

Measure	Time frame
In addition to the three time points mentioned above, the following further assessments will be conducted: • Levels of milk protein-specific antibody titers in serum • Integrity of the intestinal barrier, measured via permeability markers in stool and serum (zonulin, alpha-1 antitrypsin, secretory IgA, fecal alkaline phosphatase, Intestinal Fatty Acid-Binding Protein [I-FABP], and LPS) • Changes in microbiome composition • Changes in disease severity, measured using the EDSS (Expanded Disability Status Scale) • Self-assessment of mental and physical health, captured through various questionnaires (health questionnaire, dietary diary, dietary habits, GIDS, FIS, PSQI)	—

Measure

Time frame

In addition to the three time points mentioned above, the following further assessments will be conducted: • Levels of milk protein-specific antibody titers in serum • Integrity of the intestinal barrier, measured via permeability markers in stool and serum (zonulin, alpha-1 antitrypsin, secretory IgA, fecal alkaline phosphatase, Intestinal Fatty Acid-Binding Protein [I-FABP], and LPS) • Changes in microbiome composition • Changes in disease severity, measured using the EDSS (Expanded Disability Status Scale) • Self-assessment of mental and physical health, captured through various questionnaires (health questionnaire, dietary diary, dietary habits, GIDS, FIS, PSQI)

—

Countries

Germany

Contacts

Public ContactIsabelle Ningel

Universität Bonn, Anatomisches Institut

iningel@uni-bonn.de+49 228-287-62487

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026