Helicobacter Pylori and Body Iron in Adults

NCT03146325 | Withdrawn Phase 4 DMC

• 1 other identifier: HEISA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an etiologic trial to test the hypothesis that predicts that Helicobacter pylori eradication in asymptomatic/mildly dyspeptic adults will result in an increase in body iron. The study will assign and aims to complete the follow-up of 240 subjects half of them assigned to a highly effective FDA approved 14-day course of a 3-1 capsule containing bismuth subcitrate, metronidazole and tetracycline plus omeprazole which is now OTC. We have tested the effectiveness of this therapy in the study population and it seems to yield almost 100% eradication on PP analysis. We need the best possible, near 100% eradication rate, which we have already obtained in a pilot, to make comparisons on ITT basis and safely conclude that H pylori leads to a deficit of body iron.

Conditions

Helicobacter Pylori Infection

Keywords

H. pylori infection

Outcome Measures

Primary Outcomes (1)

• Serum Ferritin

  Changes from baseline at 6 months after completing therapy, controlled by C-reactive protein

  6 months after completing therapy

Secondary Outcomes (2)

• Body Iron

  6 months after completing therapy

• Other markers of iron stores, and erythropoiesis

  6 months after completing therapy

Study Arms (2)

PYLERA AND OMEPRAZOLE

EXPERIMENTAL

14-DAY COURSE OF 3-1 PYLERA (3 CAPSULES QID) PLUS OMEPRAZOLE (BID)

Drug: BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE

PLACEBO

PLACEBO COMPARATOR

MATCHING PLACEBOS

Drug: MATCHING PLACEBO

Interventions

BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE DRUG

A 14-day quadruple Hp eradication therapy consisting of: omeprazole (20 mg twice daily) plus 3 capsules q.i.d., each containing 420 mg of bismuth subcitrate potassium, 375 mg of metronidazole and 375 mg of tetracycline hydrochloride, for 14 days

Also known as: PYLERA, OTC OMEPRAZOLE

PYLERA AND OMEPRAZOLE

MATCHING PLACEBO DRUG

TO BE PREPARED BY LICENSED COMPOUNDING PHARMACY

PLACEBO

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults 18-65, men and women, residents of the geographic target area in El Paso, Texas, who consent to participate and complete at least 10 days of the study medication.

You may not qualify if:

• Unsure if they stay in the area, have a history of allergic reactions to any antibiotic, lack adequate specimen for culture, phenylketonurics, women who are pregnant or unwilling to use 2 modern contraceptive methods during the 2-weeks they take the medications, with a history of heavy menses, anemic, history of peptic ulcer disease or had received Helicobacter eradication therapy or have abnormal lab results for kidney and liver functions tests. Will hold the enrollment for 4 weeks to those taking PPI, bismuth salts and antibiotics, and for 3 months since last blood transfusion or receiving intravenous iron preparations.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Sparks Community Center

El Paso, Texas, 79928, United States

Location

Related Publications (1)

• Cardenas VM, Prieto-Jimenez CA, Mulla ZD, Rivera JO, Dominguez DC, Graham DY, Ortiz M. Helicobacter pylori eradication and change in markers of iron stores among non-iron-deficient children in El Paso, Texas: an etiologic intervention study. J Pediatr Gastroenterol Nutr. 2011 Mar;52(3):326-32. doi: 10.1097/MPG.0b013e3182054123.

  PMID: 21336159 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: November 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

US (1)