Helicobacter Pylori and it's Hematological Impact

August 13, 2018 updated by: Rasha Mohamed Mahmoud, Assiut University
To evaluate the effect of helicobacter pylori on the blood for proper management

Study Overview

Status

Completed

Conditions

Detailed Description

r pylori (H. pylori)is the most common infection in humans, with a marked disparity between developed and developing countries.It presents in over 50% of all stomachs in the world population, making it the most frequent infection in humanS. It displays a marked disparity in occurrence between developed countries, where its prevalence oscillates between 30% and 50%, and developing countries, where its prevalence ranges between 80% and 90%.

Although H. pylori infections are asymptomatic in most infected individuals, they are intimately related to malignant gastric conditions such as gastric cancer and gastric mucosa-associated lymphoid tissue (MALT) lymphoma and to benign diseases such as gastritis and duodenal and gastric peptic ulcers.

Since it was learned that bacteria could colonize the gastric mucosa, there have been reports in the medical literature of over 50 extragastric manifestations involving a variety medical areas of specialization. These areas include cardiology, dermatology, endocrinology, gynecology and obstetrics, hematology, pneumology, odontology, ophthalmology, otorhinolaryngology and pediatrics, and they encompass conditions with a range of clear evidence between the H. pylori infection and development of the disease.

This review focuses on hematologic diseases included in international consensus and management guides for H. pylori infection; specifically iron deficiency Anemia, vitamin B12 (cobalamin) deficiency, immune thrombocytopenia, and extranodal marginal zone mucosa-associated lymphoid tissue lymphoma (MALT Lymphoma). In addition of other hematologic diseases not included in guides and consensus as auto-immune neutropenia, antiphospholipid syndrome, and plasma cell dyscrasias.

Iron deficiency Iron deficiency (ID) is a serious public health issue, regardless of whether it is associated with anemia . It is especially important to remember that ID is a chronic process with a slow onset, in which the iron imbalance may take several years to establish and manifest clinically. One of the consequences can be observed through blood characteristics such as morphological alterations of erythrocytes or the presence of anemia, according to the criteria of the WHO.ID occurs in three stages: pre-latent (stage 1), in which ferritin is between 12 and 30 μg/L, latent (stage 2) when the ferritin falls below 12 μg/L, and ID anemia (stage 3) when anemia is present in addition to diminished or depleted reservoir iron levels (determined by serum ferritin).

Vitamin B12 deficiency Vitamin B12 is required as a coenzyme for the metabolism of the amino acids methionine, threonine and valine and for the transformation of methyl-tetrahydrofolate to tetrahydrofolate, which is necessary for DNA synthesis. Vitamin B12 deficiency, also known as cobalamin deficiency, is defined by low serum values of vitamin B12 and both homocysteine and methylmalonic acid (two components of the vitamin B12 metabolic pathway). Vitamin B12 deficiency occurs as a result of antibodies directed against gastric parietal cells and intrinsic factor, in addition to achlorhydria and a decrease in pepsinogen I and gastrin.

The laboratory diagnosis of vitamin B12 deficiency is established in accordance with the following criteria:

  1. serum vitamin B12 levels < 150 pmol/L (< 200 pg/mL) with clinical features and/or hematological anomalies related to vitamin B12 deficiency
  2. serum vitamin B12 levels < 150 pmol/L on two separate occasions .
  3. serum vitamin B12 levels < 150 pmol/L and total serum homocysteine levels > 13 μmol/L or methylmalonic acid levels > 0.4 μmol/L (in the absence of renal failure and folate and vitamin B6 deficiencies).
  4. serum holotranscobalamin levels < 35 pmol/L. Immune thrombocytopenia Primary immune thrombocytopenia (ITP), previously called idiopathic thrombocytopenic purpura and autoimmune thrombocytopenic purpura.ITP has been redefined as "an autoimmune disorder characterized by isolated thrombocytopenia (peripheral blood platelet count 100 × 109/L) in the absence of other causes or disorders that may be associated with thrombocytopenia.

Primary ITP is associated with congenital or acquired immune disorders, leading to an autoimmune response against platelets or megakaryocytes and characterized because it is not associated with other alterations.

Gastric MALT lymphoma Gastric MALT lymphoma is a rare form of non-Hodgkin lymphoma that affects B lymphocytes and typically develops in lymphoid tissue associated with mucous membranes and rarely in lymph nodes. It represents approximately 5% of all diagnosed non-Hodgkin lymphomas.

The mechanisms by which H. pylori produces the appearance of a lymphoma similar to gastric carcinogenesis has not been fully clarified, but it is likely that environmental, host, and bacterial-related factors must be involved.H. pylori infection leads to development of MALT lymphoma and can take the following course. First, the infection gives rise to a lymphocyte response that conditions a polyclonal B lymphocyte response and MALT formation through antibody production. Then, different lymphocyte populations would maintain the response provoked by the bacteria. In the polyclonal MALT proliferation, a monoclonal population of B-cells could appear and accumulate cytogenetic changes such as translocations, mutations, microsatellite instabilities, eventually evolving into a low-grade MALT lymphoma that is dependent on H. pylori-related antigen stimuli. Finally, new cytogenetic changes such as translocations, suppressor gene deactivation (p53 and p16, among others), and c-myc activation would make this neoplastic population of monoclonal B-cells escape from its dependence on T lymphocytes and H. pylori antigens and favor its transformation into a high-grade lymphoma. As a result of this sequence of events, a low- or high-grade lymphoma would ultimately develop.

UNRECOGNIZED HEMATOLOGIC MANIFESTATIONS This group includes autoimmune neutropenia, antiphospholipid syndrome, plasma cell dyscrasia including monoclonal gammopathy of undetermined significance and multiple myeloma.

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper endoscopy
Time Frame: 2 year
To demonstrate infection of H PyloruPylorifohistopathological examination
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete blood count
Time Frame: 2 year
to assess type of anemia and hematological affection
2 year
Iron studies
Time Frame: 2 year
To assess iron deficiency anemia
2 year
Vitamin B 12 level and folic acid level
Time Frame: 2 year
To demonstrate level of vitamin B12
2 year
Bone marrow aspiration
Time Frame: 2 year
To determine other causes of bone marrow affection
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 8, 2018

Study Registration Dates

First Submitted

July 15, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • H pylori

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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