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

This study is currently recruiting participants.
Verified November 2017 by Ahmed M.Kamel, Kasr El Aini Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03347513
First Posted: November 20, 2017
Last Update Posted: November 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ahmed M.Kamel, Kasr El Aini Hospital
  Purpose
the effect of eradication of H-pylori in pregnant patients with iron deficiency anemia on the level of hemoglobin after iron therapy.

Condition Intervention Phase
Pregnancy Complications Anemia, Iron Deficiency H Pylori Infection Drug: triple attack therapy Drug: Ferrous(II)-glycine-sulphate complex 567.7 mg capsules Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Eradication of H-pylori in Pregnant Patients With Iron Deficiency Anemia Have an Effect on Iron Replacement Therapy?

Resource links provided by NLM:


Further study details as provided by Ahmed M.Kamel, Kasr El Aini Hospital:

Primary Outcome Measures:
  • hemoglobin levels [ Time Frame: one month ]
    difference in mean mean hemoglobin levels


Estimated Enrollment: 150
Actual Study Start Date: November 25, 2017
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Ferro sanol duodenal ®Minapharm , Egypt

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347513


Contacts
Contact: Ahmed Kamel, M.D. 00201120022332 dr.ahmed.m.kamel@gmail.com
Contact: Emad salah, M.D. emadsalah148@gmail.com

Locations
Egypt
obstetrics and gynecology department, Kasr Alainy hospital Recruiting
Cairo, Egypt, 11562
Contact: Ahmed Kamel, M.D.       dr.ahmed.m.kamel@gamil.com   
Contact: Emad Salah, M.D.       emadsalah148@gmail.com   
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
Principal Investigator: Ahmed Kamel, M.D. Cairo University
  More Information

Publications:
Responsible Party: Ahmed M.Kamel, Assistant professor of obstetrics and gynecology, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03347513     History of Changes
Other Study ID Numbers: A15112017
First Submitted: November 15, 2017
First Posted: November 20, 2017
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ahmed M.Kamel, Kasr El Aini Hospital:
H-pylori
iron deficiency anemia
Pregnancy
iron therapy

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Pregnancy Complications
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Glycine
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action