Intraluminal Therapy for Helicobacter Pylori Infection

Intraluminal Therapy for Helicobacter Pylori Infection



Sponsors


Source

Mackay Memorial Hospital

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No

Is Us Export

No


Brief Summary

Helicobacter pylori (H. pylori) is the most common chronic bacterial infection in humans.

The prevalence of H. pylori is about 30~50% in the Western adult population. It is estimated
that about 50% of people are infected with this bacterium in Taiwan. Many studies have shown
that H. pylori is an important causal factor of chronic gastritis, peptic ulcer disease,
gastric cancer and gastric lymphoma. The World Health Organization classified H. pylori as a
Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the above
diagnosis for patient with H. pylori infection. Eradication of H. pylori infection reduces
the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication
rate of clarithromycin-based triple therapy has been declining in recent years, probably
related to the increasing resistant rate to clarithromycin. Several strategies have been
proposed to overcome the declining eradication rate, including (1) extending the treatment
duration of triple therapy to 14 days; (2) the use of bismuth quadruple therapy which
contains bismuth, a proton pump inhibitor, and two antibiotics (usually metronidazole and
tetracycline); (3) non-bismuth quadruple therapy (concomitant therapy) which contains a
proton pump inhibitor and three antibiotics (usually amoxicillin, metronidazole, and
clarithromycin); (4) sequential therapy which contains a proton pump inhibitor (PPI) plus
amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another
five days. The investigators aim to improve the eradication rate of H. pylori infection
while an endoscopic examination is performed.

Detailed Description

During the endoscopic examination, patient is sedated with intravenous Dormicum 5mg
(5mg/1ml/amp), the vital signs will be closely monitored by physiological monitor (PHILIPS
SureSigns VM6). The treatment will be terminated immediately if unstable vital sign detected
or if patient asks for termination. With endoscope apparatus, the gastric mucous is
irrigated with acetylcysteine solution and the pH value of gastric juice will be measured
with the pH test strips before irrigation and after irrigation. The investigators dispense
medicaments containing three kinds of antibiotics powder (Amoxicillin 3 gm、Metronidazole 2
gm and Clarithromycin 1 gm) on the surface of gastric mucosa and duodenal mucosa of duodenal
bulb as evenly as possible. After the intraluminal therapy, patients will rest for 30 to 60
minutes and go home if the effect of sedation subsided. Patients can take meal if no
abdominal discomfort. Patients will receive tests for serum Helicobacter pylori
immunoglobulin G, liver function and renal function 3 to 7 days after the intraluminal
therapy. C13-Urea breath test (UBT) will be used to assess the existence of H. pylori 6
weeks after the intraluminal therapy. Stool H. pylori Antigen will be used to assess the
short term recurrence of H. pylori 4-6 months after successful intraluminal therapy .
Patients fail to achieve intraluminal eradication of H. pylori will be randomly assigned to
the oral antibiotics rescue therapies with standard triple therapy for either 7 days (Group
A) or 14 days (Group B). C13-UBT will be used to assess the existence of H. pylori 6 weeks
after the rescue triple therapy. Overall eradication rates after the first line intraluminal
therapy and the oral antibiotics rescue therapies will be evaluated.

Overall Status

Recruiting

Start Date

2017-04-14

Completion Date

2019-04-01

Primary Completion Date

2018-12-01

Phase

Phase 4

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Eradication rate in the intraluminal therapy
6 weeks after finishing therapy

Secondary Outcome

Measure

Time Frame

Eradication rates in the two groups of rescue oral antibiotics therapies.
6 weeks after finishing therapy
Overall eradication rates
3-6 months after finishing intraluminal therapy
Short term recurrent rate
3-6 months after intraluminal therapy.
Incidence of adverse effects in the intraluminal therapy.
within 7 days after finishing the intraluminal therapy

Enrollment

100

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

Group A: lansoprazole 30 mg b.i.d. for 7 days Group B: lansoprazole 30 mg b.i.d. for 14 days

Arm Group Label

Group A (Drug: 7-day triple therapy)

Group B (Drug: 14-day triple therapy)


Other Name

Takepron


Intervention Type

Drug

Intervention Name


Description

Group A: amoxicillin 1 g b.i.d. for 7 days Group B: amoxicillin 1 g b.i.d. for 14 days

Arm Group Label

Group A (Drug: 7-day triple therapy)

Group B (Drug: 14-day triple therapy)


Other Name

Supercillin


Intervention Type

Drug

Intervention Name


Description

Group A: clarithromycin 500 mg b.i.d. for 7 days Group B: clarithromycin 500 mg b.i.d. for 14 days

Arm Group Label

Group A (Drug: 7-day triple therapy)

Group B (Drug: 14-day triple therapy)


Other Name

Klaricid



Eligibility

Criteria

Inclusion Criteria:

1. Patients aged greater than 20 years and less than 75 years

2. Patients have H. pylori infection without prior eradication therapy

3. Patients are willing to receive the intraluminal therapy. The written informed
consents will be obtained from all patients prior to enrollment.

Exclusion Criteria:

1. Children and teenagers aged less than 20 years, and adult greater than 75 years

2. Contraindication for endoscopic examination or food retention in the gastric lumen.

3. History of gastrectomy; Gastroduodenal stenosis、deformity or obstruction;
Gastroduodenal malignancy, including adenocarcinoma and lymphoma

4. Contraindication to treatment drugs: previous allergic reaction to antibiotics
(amoxicillin, clarithromycin, metronidazole), Proton pump inhibitors (lansoprazole),
Acetylcystein and Sucralfate; pregnant or lactating women

5. Severe concurrent acute or chronic illness: renal failure, cirrhosis of liver,
incurable malignant disease

6. Patients who cannot give informed consent by himself or herself.

Gender

All

Minimum Age

20 Years

Maximum Age

75 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Tai-cherng Liou, MD
Principal Investigator
Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan

Overall Contact

Last Name

Tai-cherng Liou, MD

Phone

886-2-25433535

Phone Ext

3993

Email



Location

Facility

Status

Contact

Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
Taipei 10449 Taiwan
Recruiting
Last Name: Tai-cherng Liou, MD
Phone: 886-2-25433535
Phone Ext: 3990
Email: [email protected]

Location Countries

Country

Taiwan


Verification Date

2017-04-01

Lastchanged Date

2017-04-20

Firstreceived Date

2017-04-14

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Mackay Memorial Hospital

Investigator Full Name

Tai-cherng Liou, MD

Investigator Title

Clinical associate professor, Department of Medicine, Mackay Medical College, New Taipei City, Taiwan


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Intervention Browse

Mesh Term

Anti-Bacterial Agents

Amoxicillin

Clarithromycin

Lansoprazole

Dexlansoprazole



Arm Group

Arm Group Label

Group A (Drug: 7-day triple therapy)

Arm Group Type

Active Comparator

Description

Intervention : Drug: 7-day triple therapy. Patients fail to achieve intraluminal eradication of H. pylori will be randomly assigned to the oral antibiotics rescue therapies with standard 7-day triple therapy ( lansoprazole 30 mg b.i.d., amoxicillin 1 g b.i.d. and clarithromycin 500 mg b.i.d. for 7 days)


Arm Group Label

Group B (Drug: 14-day triple therapy)

Arm Group Type

Sham Comparator

Description

Intervention : Drug: 14-day triple therapy. Patients fail to achieve intraluminal eradication of H. pylori will be randomly assigned to the oral antibiotics rescue therapies with standard 14-day triple therapy ( lansoprazole 30 mg b.i.d., amoxicillin 1 g b.i.d. and clarithromycin 500 mg b.i.d. for 14 days).



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Po-Hao Liao, MD

Phone

886-2-25433535

Phone Ext

3993

Email



Other Outcome

Measure

Evaluate eradication outcome of intraluminal therapy

Time Frame

6 weeks after finishing therapy

Description

Evaluate eradication outcome by endoscopy urease test, the pH value of gastric juice or urea breath test


Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

Group A: 7-day triple therapy for patients fail to achieve intraluminal eradication Group B: 14-day triple therapy for patients fail to achieve intraluminal eradication

Primary Purpose

Treatment

Masking

Investigator

Masking Description

open labeled, randomized control trial.



ClinicalTrials.gov processed this data on April 28, 2017

Conditions

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Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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