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Helicobacter PyloriPhase 2/3NCT00281047

The Influence of FP-10 on the Eradication Rates of H. Pylori by a Triple Therapy

A Phase 2/3 study testing FP-10 in people with Helicobacter Pylori, run by Hamamatsu University at 7 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

FP-10 is a food ingredient derived from milk casein. FP-10 can inhibit H. pylori to attach to the gastric epithelium. FP-10 has been made clear to decrease the intragastric urease activity (which is assumed to be produced by H. pylori) measured by the urea breath test. FP-10 can also detach H. Read more about this study

Who is it for?
Ages 15 to 90 years
Conditions the study is for
Helicobacter Pylori
What is being tested?
FP-10
How many people
138 participants
Where
7 sitesJapan
Study dates
Jan 2006to May 2006
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • pylori-positive patients who have never undergo the H. pylori eradication therapy -

Who cannot join

  • Patients not infected with H. pylori, Patients who are allergic to amoxicillin, clarithromycin, lansoprazole, 13C-urea, or milk casein
  • -

Trial locations and contacts

7 sites in 1 country.

Takahisa Furuta, MD, PhD contact

81-53-435-2850

furuta@hama-med.ac.jp

Kazunari Murakami, MD, PhD contact

81-97-586-6193

murakam@med.oita-u.ac.jp

7 sites in 1 country

Japan7 sites, 7 recruiting

  • Oita Kouseiren Tsurumi Hospital

    Beppu, Oita Prefecture, 874-8585

    Takayuki Nagai, MD. PhD, 81-977-23-7111, ikyoku@ok-tsurumi.com

    Takayuki Nagai, MD, PhD

    Recruiting

  • Senoo Clinic for Internal Medicine and Gastroenterology

    Hamamatsu, Shizuoka, 431-3125

    Kazutaka Senoo, MD, CBF00628@nifty.com

    Kazutaka Senoo, MD

    Recruiting

  • University Hospital of Hamamatsu University School of Medicine

    Hamamatsu, Shizuoka, 431-3192

    Takahisa Furuta, MD, PhD, 81-53-435-2850, furuta@hama-med.ac.jp

    Takahisa Furuta, MD, PhD

    Recruiting

  • Matsushita Clinic

    Hamamatsu, Shizuoka, 433-8121

    Fumiaki Matsushita, MD, PhD, 81-53-475-5225, fmatsushita@mail.wbs.ne.jp

    Fumiaki Matsushida, MD, PhD

    Recruiting

  • Kumagai Clinic for Internal Medicine and Gastroenterology

    Hamamatsu, Shizuoka, 435-0006

    Junichi Kumagai, MD, PhD, 81-53-422-2588, jkuma@yr.tnc.ne.jp

    Junichi Kumagai, MD, PhD

    Recruiting

  • Nakajima Clinic

    Kakegawa, Shizuoka, 436

    Hiroshi Nakamura, MD, PhD, 81-537-22-6819, mdnakajima@mail.wbs.ne.jp

    Hiroshi Nakajima, MD, PhD

    Recruiting

  • University Hospital of Oita University Faculty of Medicine

    Ōita, Oita Prefecture, 879-5593

    Kazunari Murakami, MD, PhD, 81-97-586-6193, murakam@med.oita-u.ac.jp

    Kazunari Murakami, MD, PhD

    Recruiting

Other trials in Japan

About this study

Official title: The Phase 2 Study of FP-10, the Food Ingredient Derived From Milk Casein, on the Eradication Rates of Helicobacter Pylori by a Triple Therapy With Lansoprazole, Amoxicillin, and Clarithromycin

FP-10 is a food ingredient derived from milk casein. FP-10 can inhibit H. pylori to attach to the gastric epithelium. FP-10 has been made clear to decrease the intragastric urease activity (which is assumed to be produced by H. pylori) measured by the urea breath test. FP-10 can also detach H. pylori from gastric epithelium. We have hypothesized that FP-10 increases the eradication rates by a triple therapy with a proton pump inhibitor, amoxicillin, and clarithromycin.

Read the detailed description
  1. pylori -positive patients older than 15 years of age with gastritis, gastric ulcer, duodenal ulcer, or gastroduodenal ulcer are invited to participate in the study. These patients had endoscopically and histologically proven ulcers or active chronic gastritis and are all H. pylori-positive. Written informed consent to participation must be obtained from each patient before the study.

During gastroduodenoscopy, biopsy specimens obtained from both the antrum and the corpus of the greater curvature are subjected to the bacterial susceptibility to clarithromycin by culture test or measurements of 23S rRNA mutations at positions 2142 and 2143 (from adenine to guanine).

Patients are treated with 30 mg of lansoprazole bid, 200 mg of clarithromycin bid, and 750 mg of amoxicillin bid for one week. In addition, they take placebo bid, FP10 1 g bid, or FP-10 2 g bid (2 hour after breakfast and at the bed time) for the same one week. Administration of placebo, FP-10 1 g or FP-10 2 g are performed in a double blinded manner.

Eradication of H. pylori was confirmed by a 13C-urea breath test performed one month after eradication therapy. Throughout the study period, the investigators involved in the assessment of H. pylori eradication are blinded to susceptibility to clarithromycin H. pylori strains.

Being tested
FP-10
Keywords
Helicobacter pylori (H. pylori), FP-10, amoxicillin, clarithromycin, lansoprazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FP-10Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The effect of FP-01 on the eradication rates of H. pylori infection by a triple therapy

Secondary outcomes (1)

  1. The effect o FP-10 on the eradication rates of clarithromycin-sensitive and -resistant strains of H. pylori by a triple therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2006 (estimated)
  2. Study startJan 2006
  3. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
138 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00281047
Sponsor's protocol ID
Hp.FP-10.01
Status last verified
Jan 2006
First submitted
23 Jan 2006
Last updated
27 Jan 2006
Results posted
No

Publications

  • Furuta T, Sagehashi Y, Shirai N, Sugimoto M, Nakamura A, Kodaira M, Kenmotsu K, Nagano M, Egashira T, Ueda K, Yoneyama M, Ohashi K, Ishizaki T, Hishida A. Influence of CYP2C19 polymorphism and Helicobacter pylori genotype determined from gastric tissue samples on response to triple therapy for H pylori infection. Clin Gastroenterol Hepatol. 2005 Jun;3(6):564-73. doi: 10.1016/s1542-3565(04)00779-7.

    PubMed 15952098

  • Shirai N, Furuta T, Sugimoto M, Nakamura A. [High dose dual PPI/AMPC therapy for the treatment of Helicobacter pylori infection after failure of usual standard triple PPI/AMPC/CAM therapy]. Nihon Rinsho. 2005 Nov;63 Suppl 11:438-41. No abstract available. Japanese.

    PubMed 16363575

  • Okudaira K, Miura S, Furuta T, Sugimoto M, Shirai N. [Concomitant dosing of a H2 receptor antagonist (H2RA) with a triple therapy increases the cure rate of Helicobacter pylori infection]. Nihon Rinsho. 2005 Nov;63 Suppl 11:391-6. No abstract available. Japanese.

    PubMed 16363566

  • Furuta T, Shirai N, Sugimoto M, Nakamura A, Hishida A, Ishizaki T. Influence of CYP2C19 pharmacogenetic polymorphism on proton pump inhibitor-based therapies. Drug Metab Pharmacokinet. 2005 Jun;20(3):153-67. doi: 10.2133/dmpk.20.153.

    PubMed 15988117

  • Furuta T, Shirai N, Sugimoto M, Nakamura A, Okudaira K, Kajimura M, Hishida A. Effect of concomitant dosing of famotidine with lansoprazole on gastric acid secretion in relation to CYP2C19 genotype status. Aliment Pharmacol Ther. 2005 Jul 1;22(1):67-74. doi: 10.1111/j.1365-2036.2005.02523.x.

    PubMed 15963082

  • Okudaira K, Furuta T, Shirai N, Sugimoto M, Miura S. Concomitant dosing of famotidine with a triple therapy increases the cure rates of Helicobacter pylori infections in patients with the homozygous extensive metabolizer genotype of CYP2C19. Aliment Pharmacol Ther. 2005 Feb 15;21(4):491-7. doi: 10.1111/j.1365-2036.2005.02353.x.

    PubMed 15710002

  • Murakami K, Fujioka T. [Drug resistant H. pylori in Japan: general remarks]. Nihon Rinsho. 2005 Nov;63 Suppl 11:198-202. No abstract available. Japanese.

    PubMed 16363531

  • Murakami K, Kodama M, Sato R, Okimoto T, Watanabe K, Fujioka T. Helicobacter pylori eradication and associated changes in the gastric mucosa. Expert Rev Anti Infect Ther. 2005 Oct;3(5):757-64. doi: 10.1586/14787210.3.5.757.

    PubMed 16207167

  • Murakami K, Sato R, Okimoto T, Watanabe K, Nasu M, Fujioka T, Kodama M, Kagawa J. Influence of anti-ulcer drugs used in Japan on the result of (13)C-urea breath test for the diagnosis of Helicobacter pylori infection. J Gastroenterol. 2003;38(10):937-41. doi: 10.1007/s00535-003-1176-x.

    PubMed 14614600

  • Hiramoto S, Itoh K, Shizuuchi S, Kawachi Y, Morishita Y, Nagase M, Suzuki Y, Nobuta Y, Sudou Y, Nakamura O, Kagaya I, Goshima H, Kodama Y, Icatro FC, Koizumi W, Saigenji K, Miura S, Sugiyama T, Kimura N. Melanoidin, a food protein-derived advanced maillard reaction product, suppresses Helicobacter pylori in vitro and in vivo. Helicobacter. 2004 Oct;9(5):429-35. doi: 10.1111/j.1083-4389.2004.00263.x.

    PubMed 15361082

  • Murakami K, Sato R, Okimoto T, Nasu M, Fujioka T, Kodama M, Kagawa J. Efficacy of triple therapy comprising rabeprazole, amoxicillin and metronidazole for second-line Helicobacter pylori eradication in Japan, and the influence of metronidazole resistance. Aliment Pharmacol Ther. 2003 Jan;17(1):119-23. doi: 10.1046/j.1365-2036.2003.01401.x.

    PubMed 12492740

  • Murakami K, Sato R, Okimoto T, Nasu M, Fujioka T, Kodama M, Kagawa J, Sato S, Abe H, Arita T. Eradication rates of clarithromycin-resistant Helicobacter pylori using either rabeprazole or lansoprazole plus amoxicillin and clarithromycin. Aliment Pharmacol Ther. 2002 Nov;16(11):1933-8. doi: 10.1046/j.1365-2036.2002.01368.x.

    PubMed 12390102

  • Murakami K, Nasu M. [Clarithromycin (CAM)]. Nihon Rinsho. 2002 Feb;60 Suppl 2:667-70. No abstract available. Japanese.

    PubMed 11979867

  • Murakami K, Nasu M. [Drug sensitivity test for Helicobacter pylori]. Nihon Rinsho. 2002 Feb;60 Suppl 2:350-3. No abstract available. Japanese.

    PubMed 11979806

  • Murakami K, Fujioka T, Okimoto T, Sato R, Kodama M, Nasu M. Drug combinations with amoxycillin reduce selection of clarithromycin resistance during Helicobacter pylori eradication therapy. Int J Antimicrob Agents. 2002 Jan;19(1):67-70. doi: 10.1016/s0924-8579(01)00456-3.

    PubMed 11814770

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing FP-10 in people with Helicobacter Pylori, run by Hamamatsu University at 7 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Takahisa Furuta, MD, PhD (81-53-435-2850, furuta@hama-med.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of FP-01 on the eradication rates of H. pylori infection by a triple therapy. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00281047, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2006.

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