Lactose Intolerance and Cow's Milk Protein Allergy in Non-celiac Wheat Sensitivity Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03008252
• Date of registration: 29/12/2016
• Prospective Registration: Yes
• Primary sponsor: University of Palermo
• Public title: Lactose Intolerance and Cow's Milk Protein Allergy in Non-celiac Wheat Sensitivity Patients
• Scientific title: Lactose Intolerance and Cow's Milk Protein Allergy in Non-celiac Wheat Sensitivity Patients
• Date of first enrolment: January 1, 2017
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03008252
• Study type: Observational

Countries of recruitment

Italy

Contacts

• Name: Antonio Carroccio, PhD
• Affiliation: University of Palermo

Key inclusion & exclusion criteria

Inclusion Criteria:

All the NCWS patients will meet the recently proposed criteria:

- negative serum anti-tissue transglutaminase and antiendomysium (EmA) IgA and IgG
antibodies

- absence of intestinal villous atrophy

- IgE-mediated immunoallergy tests negative to wheat and cow's milk protein (skin prick
tests and/or serum specific IgE detection).

Adjunctive criteria adopted in our patients will be:

- resolution of the gastrointestinal and extra-intestinal symptoms on a standard
elimination diet, without wheat, cow's milk, egg, tomato, chocolate, or other food(s)
causing self-reported symptoms

- symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge,
performed as described previously.

Exclusion Criteria:

Exclusion criteria will be:

- age <18 years

- positive EmA in the culture medium of the duodenal biopsies, even if the villi to
crypts ratio in the duodenal mucosa was normal

- self-exclusion of wheat from the diet and refusal to reintroduce it before entering
the study

- other organic cutaneous and/or gastrointestinal diseases

- concomitant treatment with steroids and/or antihistamines.

Lactose intolerance and CMPA will be diagnosed, in patients with self-reported
gastrointestinal and extra-intestinal symptoms related to milk and/or milk derivates
ingestion, using lactose breath test and DBPC cow's milk protein challenge, respectively.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non-celiac Wheat Sensitivity

Intervention(s)

Other: Lactose breath test

Other: DBPC cow's milk protein challenge

Primary Outcome(s)

Positive lactose breath test and DBPC cow's milk protein challenge in NCWS patients self-reporting symptoms related to milk and/or milk derivates ingestion. [Time Frame: January 2017 to December 2017]

Secondary Outcome(s)

Lactose intolerance and CMPA in NCWS patients [Time Frame: January 2017 to December 2017]

Secondary ID(s)

ACPM12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors