RESTORE study

Reduction of food allergy sensitivity by consumption of raw milk kefir - RESTORE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58243

Enrollment

Registered

2025-06-11

Start date

2026-06-03

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

Food allergy Food allergy

Interventions

Consumption of raw milk kefir (150 mL, twice a day)

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: signed informed consent, 18 years of age or older, mentally competent, patients with challenge proven (<2 years ago) food allergy to either peanut or tree nuts  

Exclusion criteria

Exclusion criteria: Cow's milk allergy Patient eats peanut and tree nuts without complaints.Anafylactic reaction to the peanut or tree nut of interest in the past. Negative food challenge with peanut or tree nuts. Unable to stop antihistamines 72 hours before food challenge.Regular consumption of raw milk kefir (>1 times a week) prior to the study

Design outcomes

Primary

Measure	Time frame
the change in eliciting dose of peanut and tree nut allergy during an oral food challenge.	—

Secondary

Measure	Time frame
Clinical assessment: Change in symptom severity (e.g. from severe to moderate, from moderate to mild) during the OFC for peanut or tree nuts, compared to the baseline OFC;Change in ED and symptom severity of BPFA during the home introduction. Patient reported outcomes;Change in FAQLQ scores before and 6 months of RMK consumption;Change in perceived immune status before and 6 months of RMK consumption;Change in perceived bowel problems before and 6 months of RMK consumption.Immune parameters in blood and stool; Change in sensitization (IgE levels) and cytokine profile (of for example TGF-ß, IL-6, and IL-13)in serum before and after RMK consumption;Difference in PBMC responses to allergen specific and non-specific stimuli before and after 3 and 6 months RMK consumption;Differences in the activation of blood basophils to peanut or tree nuts measured in full blood with the BAT assay, before, after 3 months and after 6 months RMK consumption; Change of intestinal bacterial composition Change of SCFA content in plasma and stool before and after 3 and 6 months of RMK consumption.Change of fecal sIgA and calprotectin content in stool before and after 3 and 6 months of RMK consumption.	—

Measure

Time frame

Clinical assessment: Change in symptom severity (e.g. from severe to moderate, from moderate to mild) during the OFC for peanut or tree nuts, compared to the baseline OFC;Change in ED and symptom severity of BPFA during the home introduction. Patient reported outcomes;Change in FAQLQ scores before and 6 months of RMK consumption;Change in perceived immune status before and 6 months of RMK consumption;Change in perceived bowel problems before and 6 months of RMK consumption.Immune parameters in blood and stool; Change in sensitization (IgE levels) and cytokine profile (of for example TGF-ß, IL-6, and IL-13)in serum before and after RMK consumption;Difference in PBMC responses to allergen specific and non-specific stimuli before and after 3 and 6 months RMK consumption;Differences in the activation of blood basophils to peanut or tree nuts measured in full blood with the BAT assay, before, after 3 months and after 6 months RMK consumption; Change of intestinal bacterial composition Change of SCFA content in plasma and stool before and after 3 and 6 months of RMK consumption.Change of fecal sIgA and calprotectin content in stool before and after 3 and 6 months of RMK consumption.

—

Countries

Netherlands

Contacts

Public ContactECAM van Esch

Universiteit Utrecht

e.c.a.m.vanesch@uu.nl31 634146611

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 25, 2026