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

NCT03347513 | Unknown Phase 4 DMC

• 1 other identifier: A15112017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Complications; Anemia, Iron Deficiency; H Pylori Infection

Keywords

H-pylori; iron deficiency anemia; Pregnancy; iron therapy

Outcome Measures

Primary Outcomes (1)

• hemoglobin levels

  difference in mean mean hemoglobin levels

  one month

Study Arms (2)

Eradication of H-pylori

EXPERIMENTAL

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; Drug: Ferrous(II)-glycine-sulphate complex 567.7 mg capsules

No eradication of H-pylori

ACTIVE COMPARATOR

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

Interventions

triple attack therapy DRUG

eradication of H-pylori using triple attack therapy.

Also known as: KLACID XL 500 mg, HEALSEC 20 mg, Flagyly 500 mg

Eradication of H-pylori

Ferrous(II)-glycine-sulphate complex 567.7 mg capsules DRUG

Iron therapy will be given to both groups twice daily for one month.

Also known as: Ferro sanol duodenal ®Minapharm , Egypt

Eradication of H-pylori; No eradication of H-pylori

Eligibility Criteria

• Age: Up to 40 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

obstetrics and gynecology department, Kasr Alainy hospital

Cairo, 11562, Egypt

RECRUITING

Related Publications (3)

• Nashaat EH, Mansour GM. Helicobacter pylori and anemia with pregnancy. Arch Gynecol Obstet. 2014 Jun;289(6):1197-202. doi: 10.1007/s00404-013-3138-8. Epub 2013 Dec 28.

  PMID: 24374855 BACKGROUND

• Breymann C, Honegger C, Hosli I, Surbek D. Diagnosis and treatment of iron-deficiency anaemia in pregnancy and postpartum. Arch Gynecol Obstet. 2017 Dec;296(6):1229-1234. doi: 10.1007/s00404-017-4526-2. Epub 2017 Sep 22.

  PMID: 28940095 BACKGROUND

• Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017 Feb;112(2):212-239. doi: 10.1038/ajg.2016.563. Epub 2017 Jan 10.

  PMID: 28071659 BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications; Anemia, Iron-Deficiency

Interventions

ferroglycine sulfate

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ahmed Kamel, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Kamel, M.D.

CONTACT

00201120022332; dr.ahmed.m.kamel@gmail.com

Emad salah, M.D.

CONTACT

emadsalah148@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of obstetrics and gynecology

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: November 25, 2017
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: December 4, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)