Lactose Intolerance and Cow's Milk Protein Allergy in Non-celiac Wheat Sensitivity Patients
Condition: Non-celiac Wheat Sensitivity
MeSH terms: Lactose Intolerance; Hypersensitivity; Milk Hypersensitivity
Study type: Observational

Summary: 
      In the last few years a new clinical entity has emerged which includes patients who consider
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
      they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named
      non-celiac gluten sensitivity (NCGS), although in a recent article, the researchers suggested
      the term "non-celiac wheat sensitivity" (NCWS), because it is not known to date what
      component of wheat actually causes the symptoms. The clinical picture of NCWS is
      characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or
      constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and
      extra-intestinal or systemic manifestations (headache, depression, anxiety, 'foggy mind,'
      tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,
      and anemia). Lactose intolerance and cow's milk protein allergy (CMPA) are two medical
      conditions with a very high prevalence in the general population, and there is a large
      overlap between NCWS symptoms and lactose intolerance and CMPA symptoms. Therefore, the aims
      of the present study are to investigate 1) the prevalence of positive lactose breath test and
      DBPC cow's milk protein challenge in NCWS patients with self-reported gastrointestinal
      symptoms related to milk and/or milk derivates ingestion, 2) the clinical, serological, and
      histological characteristics of NCWS patients with lactose intolerance and CMPA in comparison
      to NCWS patients without lactose intolerance and CMPA.
    

Detailed description: 
      In the last few years, a new clinical entity has emerged which includes patients who consider
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
      they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named
      non-celiac gluten sensitivity (NCGS), although in a recent article, the researchers suggested
      the term "non-celiac wheat sensitivity" (NCWS), because it is not known to date what
      component of wheat actually causes the symptoms. Other areas of doubt in NCWS regard its
      pathogenesis, while some papers reported intestinal immunologic activation, others linked
      NCWS to the dietary short chain carbohydrate (fermentable oligo-di-monosaccharides and
      polyols, FODMAPs) load. The researchers recently demonstrated that higher proportions of
      patients with NCWS develop autoimmune disorders, are antinuclear antibodies (ANA) positive,
      and show DQ2/DQ8 haplotypes compared with patients with irritable bowel syndrome (IBS),
      supporting an immunologic involvement in NCWS. The clinical picture of NCWS is characterized
      by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or constipation, nausea,
      epigastric pain, gastroesophageal reflux, aphthous stomatitis) and extra-intestinal or
      systemic manifestations (headache, depression, anxiety, 'foggy mind,' tiredness, dermatitis
      or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). Lactose
      intolerance and cow's milk protein allergy (CMPA) are two conditions with a very high
      prevalence in the general population and there is a large overlap between NCWS and lactose
      intolerance and CMPA symptoms. Therefore, the aims of the present study are to investigate 1)
      the prevalence of positive lactose breath test and DBPC cow's milk protein challenge in NCWS
      patients with self-reported gastrointestinal and extra-intestinal symptoms related to milk
      and/or milk derivates ingestion, 2) the clinical, serological, and histological
      characteristics of NCWS patients with lactose intolerance and CMPA in comparison to NCWS
      patients without lactose intolerance and CMPA.
    

Intervention name(s): Lactose breath test; DBPC cow's milk protein challenge
Intervention type(s): Other; Other
Intervention description(s): Lactose breath test in NCWS patients with symptoms related to milk and/or milk derivates ingestion.; DBPC cow's milk protein challenge in NCWS patients with symptoms related to milk and/or milk derivates ingestion.
Intervention MeSH terms: Caseins
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The researchers prospectively will survey adult patients with functional
        gastroenterological symptoms (Rome III criteria) and a definitive diagnosis of NCWS,
        referred at the Department of Internal Medicine at the University Hospital of Palermo,
        Italy, and at the Department of Internal Medicine of the Hospital of Sciacca, Agrigento,
        Italy, between January 2017 and January 2019, comparing the characteristics of the ones
        suffering from lactose intolerance and CMPA with those who do not suffer from lactose
        intolerance and CMPA.
      
Keywords: Non-celiac wheat sensitivity; lactose intolerance; cow's milk protein allergy