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

NCT03008252 | Completed

• 1 other identifier: ACPM12
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Non-celiac Wheat Sensitivity

Keywords

Non-celiac wheat sensitivity; lactose intolerance; cow's milk protein allergy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  January 2017 to December 2017

Secondary Outcomes (1)

• Lactose intolerance and CMPA in NCWS patients

  January 2017 to December 2017

Interventions

Lactose breath test OTHER

Lactose breath test in NCWS patients with symptoms related to milk and/or milk derivates ingestion.

DBPC cow's milk protein challenge OTHER

DBPC cow's milk protein challenge in NCWS patients with symptoms related to milk and/or milk derivates ingestion.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (2)

Internal Medicine Department of the Hospital of Sciacca (Agrigento)

Sciacca, Agrigento, 92019, Italy

Location

Internal Medicine Department of the University Hospital of Palermo

Palermo, 90127, Italy

Location

Related Publications (9)

• Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.

  PMID: 22825366 RESULT

• Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996.

  PMID: 24533607 RESULT

• Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.

  PMID: 24275240 RESULT

• Carroccio A, D'Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24. No abstract available.

  PMID: 25625764 RESULT

• Carroccio A, Soresi M, D'Alcamo A, Sciume C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. BMC Med. 2014 Nov 28;12:230. doi: 10.1186/s12916-014-0230-2.

  PMID: 25430806 RESULT

• Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18.

  PMID: 25694210 RESULT

• Carroccio A, Brusca I, Mansueto P, D'alcamo A, Barrale M, Soresi M, Seidita A, La Chiusa SM, Iacono G, Sprini D. A comparison between two different in vitro basophil activation tests for gluten- and cow's milk protein sensitivity in irritable bowel syndrome (IBS)-like patients. Clin Chem Lab Med. 2013 Jun;51(6):1257-63. doi: 10.1515/cclm-2012-0609.

  PMID: 23183757 RESULT

• Carroccio A, Montalto G, Custro N, Notarbartolo A, Cavataio F, D'Amico D, Alabrese D, Iacono G. Evidence of very delayed clinical reactions to cow's milk in cow's milk-intolerant patients. Allergy. 2000 Jun;55(6):574-9. doi: 10.1034/j.1398-9995.2000.00417.x.

  PMID: 10858991 RESULT

• Carroccio A, Montalto G, Cavera G, Notarbatolo A. Lactose intolerance and self-reported milk intolerance: relationship with lactose maldigestion and nutrient intake. Lactase Deficiency Study Group. J Am Coll Nutr. 1998 Dec;17(6):631-6. doi: 10.1080/07315724.1998.10718813.

  PMID: 9853544 RESULT

MeSH Terms

Conditions

Lactose Intolerance; Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Antonio Carroccio, PhD

  University of Palermo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 2, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: June 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)