Helicobacter Pylori and it's Hematological Impact

NCT03629587 | Completed

• 1 other identifier: H pylori
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the effect of helicobacter pylori on the blood for proper management

Conditions

H Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Upper endoscopy

  To demonstrate infection of H PyloruPylorifohistopathological examination

  2 year

Secondary Outcomes (4)

• Complete blood count

  2 year

• Iron studies

  2 year

• Vitamin B 12 level and folic acid level

  2 year

• Bone marrow aspiration

  2 year

Study Arms (2)

Patients presented H pylori positive

Upper endoscopy, Gastric biopsy, CBC, VITAMIN B12 level, iron studys, folic acid level, bone marrow aspirate

Patients with H pylori negative

Upper endoscopy, Gastric biopsy, CBC, VITAMIN B12 level, iron studys, folic acid level, bone marrow aspirate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients were presented with symptoms suggesting of gastritis, Group (A) 50 patients with positive H .Pylori biopsy, Group (B): 50 patients with negative H.pylori biopsy. All patients and control group were submitted to:1- Detailed history of age, sex, associate diseases, and family history of the same illness or others.2- Detailed history about gastric symptoms and duration of the disease 3-Full clinical examination 4- Laboratory investigations including: * Complete blood count with reticulocytic count.- Upper endoscopy - Diagnostic biopsy * Serum iron, total iron binding capacity and serum Ferritin.- Vitamin B 12 and folic acid level if indicated- Bone marrow aspirate if indicated.

You may qualify if:

• All patients complained of symptoms suggestive of gastritis whether acute (within two weeks) or chronic (three or more months) and were diagnosed at endoscopy to have H.pylori infection by biopsy.
• Patients aged more than 18 years old.
• Both sexes (male \& female).

You may not qualify if:

• Patients with malignant diseases or Gastric malignancy.
• Other causes of Thrombocytopenia as systemic lupus erythematous and human immunodeficiency virus and or acquired immunodeficiency syndrome.
• Other causes of Anemias with or without blood loss.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Fischbach W, Malfertheiner P. Helicobacter Pylori Infection. Dtsch Arztebl Int. 2018 Jun 22;115(25):429-436. doi: 10.3238/arztebl.2018.0429.

  PMID: 29999489 BACKGROUND

• Martinson HA, Shelby NJ, Alberts SR, Olnes MJ. Gastric cancer in Alaska Native people: A cancer health disparity. World J Gastroenterol. 2018 Jul 7;24(25):2722-2732. doi: 10.3748/wjg.v24.i25.2722.

  PMID: 29991877 BACKGROUND

• Fukuda T, Asou E, Nogi K, Yasuda M, Goto K. Association between Helicobacter pylori infection and platelet count in mice. Exp Anim. 2018 Nov 1;67(4):487-492. doi: 10.1538/expanim.18-0004. Epub 2018 Jun 7.

  PMID: 29877197 BACKGROUND

• Best LM, Takwoingi Y, Siddique S, Selladurai A, Gandhi A, Low B, Yaghoobi M, Gurusamy KS. Non-invasive diagnostic tests for Helicobacter pylori infection. Cochrane Database Syst Rev. 2018 Mar 15;3(3):CD012080. doi: 10.1002/14651858.CD012080.pub2.

  PMID: 29543326 BACKGROUND

• Barbosa AMC, Ribeiro RA, Silva CISM, Cruz FWS, Azevedo OGR, Pitombeira MHDS, Braga LLC. Platelet count response to Helicobacter pylori eradication for idiopathic thrombocytopenic purpura in northeastern Brazil. Hematol Transfus Cell Ther. 2018 Jan-Mar;40(1):12-17. doi: 10.1016/j.bjhh.2017.09.005. Epub 2017 Nov 24.

  PMID: 29519366 BACKGROUND

• Kim H, Lee WS, Lee KH, Bae SH, Kim MK, Joo YD, Zang DY, Jo JC, Lee SM, Lee JH, Lee JH, Kim DY, Ryoo HM, Hyun MS, Kim HJ; CoOperative Study Group A for Hematology (COSAH). Efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenia patients with moderate thrombocytopenia. Ann Hematol. 2015 May;94(5):739-46. doi: 10.1007/s00277-014-2268-9. Epub 2014 Dec 13.

  PMID: 25501820 BACKGROUND

• Papagiannakis P, Michalopoulos C, Papalexi F, Dalampoura D, Diamantidis MD. The role of Helicobacter pylori infection in hematological disorders. Eur J Intern Med. 2013 Dec;24(8):685-90. doi: 10.1016/j.ejim.2013.02.011. Epub 2013 Mar 21.

  PMID: 23523153 BACKGROUND

• Jafarzadeh A, Akbarpoor V, Nabizadeh M, Nemati M, Rezayati MT. Total leukocyte counts and neutrophil-lymphocyte count ratios among Helicobacter pylori-infected patients with peptic ulcers: independent of bacterial CagA status. Southeast Asian J Trop Med Public Health. 2013 Jan;44(1):82-8.

  PMID: 23682441 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Histopathological tissues and blood samples

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator at internal medicine department, principle investigator

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: August 14, 2018
• Study Start: September 27, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 8, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share