Wheat-free diet in patients with multiple sclerosis

Not Applicable

• Conditions: G35; Multiple sclerosis

• Registration Number: DRKS00027967
• Lead Sponsor: niversitätsmedizin der Johannes Gutenberg-Universität Mainz

Brief Summary

Results: The primary endpoint was negative, as the frequency of circulating pro-inflammatory T cells did not decrease during the ATI-reduced diet. We did, however, observe decreased frequencies of CD14+ CD16++ monocytes and a concomitant increase in CD14++ CD16- monocytes during the wheat-reduced diet interval. This was accompanied by an improvement in pain-related quality of life in health-related quality of life assessed (SF-36). Conclusion: Our results suggest that the wheat- and thus ATI-reduced diet was associated with changes in monocyte subsets and improved pain-related quality of life in RRMS patients. Thus, a wheat (ATI)-reduced diet might be a complementary approach accompanying immunotherapy for some patients.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-05-24
• Study Start: 2022-02-14
• Results First Posted: 2023-06-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

RRMS according to McDonald 2010 criteria
Age 18-60 years
Stable disease course on mild/moderate DMT
No other autoimmune disease or immunotherapy

Exclusion Criteria

Chronic progr. MS according to McDonald 2010 criteria
Age under 18 years
Age over 60 years
Clinical and radiological signs of disease activity
other autoimmune disease
immunotherapy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in immune cell phenotype during gluten-reduced diet. Therefore, immune cell characterisation by flow cytometry will be performed at the following points in time:<br><br>Baseline: Immunophenotyping<br><br>Week 12: Immunophenotyping<br><br>Week 24: Immunophenotyping

Secondary Outcome Measures

Name	Time	Method
Change in clinical parameters of disease activity, disability, pain, and GIP excretion in urine. Therefore, the following parameter will additionally assessed:<br><br>Baseline: EDSS, SF-36, Diet questionnaire, GIP in urine;<br><br>Week 6: EDSS, SF-36, Diet questionnaire, GIP in urine;<br><br>Week 12: EDSS, <br>SF-36, Diet questionnaire, GIP in urine;<br><br>Week 18: EDSS, SF-36, Diet questionnaire, GIP in urine;<br><br>Week 24: EDSS, SF-36, Diet questionnaire, GIP in urine