Eradication of H-pylori in Pregnancy and Its Effect on Iron Replacement Therapy?

December 2, 2018 updated by: Ahmed M.Kamel, Kasr El Aini Hospital

Does Eradication of H-pylori in Pregnant Patients With Iron Deficiency Anemia Have an Effect on Iron Replacement Therapy?

the effect of eradication of H-pylori in pregnant patients with iron deficiency anemia on the level of hemoglobin after iron therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

After approval of the "Ethics Committee" of the obstetrics and gynecology department of the faculty of medicine Cairo University, a clinical trial will be started in which pregnant patients with iron deficiency anemia will be recruited out of the antenatal care clinic. Routine complete blood count (CBC) is done early during the second trimester for cases with anemia discovered by labs drawn on their booking appointment during their 1st antenatal care visit.

IDA defined as hemoglobin below 11gm/dl with MCV below 80 fl, with one of the following: if the serum ferritin level is below 70 μg/L. or if transferrin saturation is below 20.

We based our sample size according to the work done by Nashaat & Mansour, 2014 who studied a difference in the mean hemoglobin level of 1.6 g/dl with a standard deviation of 3.3. The ratio of women in the control group to experimental group was set at 1:1, the power at 0.8, and the type I error at 0.05 which gave us 68 subjects in every arm. We allowed for 10% dropouts finally giving us 75 subjects on each study arm.

After obtaining informed consent, H-pylori infection will be diagnosed using a stool antigen assay ABON which is one step H. pylori antigen test device (®Inverness Medical Innovation Hong Kong Limited). A stool sample will be collected and the top screwed on. An applicator will then be introduced into the sample after unscrewing of the cap in three different sites to collect at least 50 mg of fecal matter. The sample will be centrifuged at 4000 rpm for 5 minutes and the supernatant will be used for immunoassay. Two drops will be placed on the kit as per kit instructions. This test utilizes lateral chromatographic assay where after 10 minutes a positive sample will have a purple-pink line in addition to the control line, while a negative test only has the control line present. If the control line was missing the test will be considered invalid.

All the enrolled participants will then be randomized into two groups using a computer generated randomization table and a sealed envelope system to be opened by the nurse in the next antenatal care visit. When the envelope is opened the participant will be assigned to either group (A) (eradication of H-pylori before iron therapy) or group (B) (start iron therapy without eradication o f H-pylori).

Participants in group A will undergo eradication of H-pylori using triple attack therapy according to O'Connor et al, 2013 with Proton pump inhibitor (eg, omeprazole 20 mg BID), Clarithromycin 500 mg BID, metronidazole 500 mg BID for 14 days, followed by confirmation of eradication by repeating the H-pylori stool antigen test .

Iron therapy will be given to both groups twice daily for one month in the form ferrous(II)-glycine-sulphate complex 567.7 mg capsules (each capsule contains about 100 mg elemental iron) Ferro sanol duodenal ®Minapharm , Egypt. All recruited cases will undergo blood sampling for complete blood count (CBC), serum ferritin, transferrin saturation, and total iron binding capacity (TIBC) before and after iron therapy. All demographic data along with relevant history taking and examination will be recorded at the beginning of recruitment including age, body mass index (BMI), and parity e.t.c.

PS Power and Sample Size Calculations software, version 2.1.30 for MS Windows, was used to calculate sample size (Dupont and Vanderbilt, Nashville, TN).

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

No older than 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosed Iron deficiency anemia.
  • H-pylori positive cases.
  • Second trimester pregnancy.

Exclusion Criteria:

  • Severe Iron deficiency anemia (hemoglobin < 8.0 g/dL).
  • Parasitic worm infection e.g. schistosomiasis, and hook worm by stool analysis.
  • Any cases giving clinical symptoms of gastritis e.g. nausea, vomiting, dull aching pain or soreness in the epigastrium.
  • Cases with history of gastric ulcer diagnosed by upper endoscopy.
  • Cases complaining of hematemesis.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eradication of H-pylori

triple attack therapy (Clarithromycin 500 mg BID for 14 days, omeprazole 20 mg BID for 14 days, metronidazole 500 mg BID for 14 days).

Followed by confirmation of eradication by repeating the H-pylori stool antigen test.

Iron therapy will be given twice daily for one month in the form ferrous(II)-glycine-sulphate complex 567.7 mg capsules (each capsule contains about 100 mg elemental iron) Ferro sanol duodenal ®Minapharm, Egypt.
Drug: triple attack therapy
eradication of H-pylori using triple attack therapy.
Other Names:
  • KLACID XL 500 mg
  • HEALSEC 20 mg
  • Flagyly 500 mg
Drug: Ferrous(II)-glycine-sulphate complex 567.7 mg capsules
Iron therapy will be given to both groups twice daily for one month.
Other Names:
  • Ferro sanol duodenal ®Minapharm , Egypt
Active Comparator: No eradication of H-pylori
Iron therapy will be given twice daily for one month in the form ferrous(II)-glycine-sulphate complex 567.7 mg capsules (each capsule contains about 100 mg elemental iron) Ferro sanol duodenal ®Minapharm, Egypt.
Drug: Ferrous(II)-glycine-sulphate complex 567.7 mg capsules
Iron therapy will be given to both groups twice daily for one month.
Other Names:
  • Ferro sanol duodenal ®Minapharm , Egypt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemoglobin levels
Time Frame: one month
difference in mean mean hemoglobin levels
one month

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Ahmed Kamel, M.D., Cairo 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)

November 25, 2017

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 2, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A15112017

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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