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OpenTrials
Completed

NCT Number: NCT02721355

Effect of Chicken Egg Antibody (IgY) on Patients With Chronic Gastritis

H. pylori positive patient volunteers that passed the selection criteria are recruited and divided into a test and a control group. Both groups are treated with a current treatment regime (EAC: Esomeprazole 40 mg/day; Clarithromycin 1000 mg/day; Amoxicillin 2000 mg/day) but only the test group received IgY-containing food supplement as an adjunctive measure for 15 days. The subjects are examined before and 4 weeks after the treatment initiation by Urea Breath Test (UBT) and gastro-endoscopy.

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Key information

Conditions

Chronic Gastritis Caused by Helicobacter Pylori Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases Stomach Ulcer

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

108 Military Central Hospital

Hanoi, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with gastritis or gastric ulcer who are positive to H. pylori

Exclusion criteria

  • People allergic to egg proteins

Treatment and study plan

GastimunHP

Dietary Supplement

Health food supplement containing specific IgY against urease of H. pylori

Primary outcomes

  1. UBT Values at Baseline and 8 Weeks

    Time frame: 8 weeks

    Urea Breath test (UBT) value was examined at baseline (0 week) and 8 weeks later. A commercial kit was used following the instructions from the manufacturer. A cut off value of 50 is considered to be positive. Higher UBT values indicate worse outcome.

Secondary outcomes

  1. Number of Participants With a Reduction in Severity of Abdominal Pain at 1 and 4 Weeks

    Time frame: 4 weeks

    Outcome measures are the Gastrointestinal Symptom Rating Scale (GSRS) scores using a four-point graded scale (0 = none: no symptoms; 1 = mild: awareness of sign or symptom, but easily tolerated; 2 = moderate: discomfort sufficient to cause interference with normal activities; 3 = severe: incapacitating with inability to perform normal activities).

  2. Number of Participants With a Reduction in Gastrointestinal Symptom Rating Scale (GSRS) Scores at 1 and 4 Weeks

    Time frame: 4 weeks

    Outcome measures are the Gastrointestinal Symptom Rating Scale (GSRS) scores using a four-point graded scale (0 = no nausea; 1 = occasional episodes of short duration; 2 = frequent and prolonged nausea, no vomiting; 3 = continuous nausea, frequent vomiting)

Other outcomes

  1. Number of Participants With Reduced Bloating After 1 Week

    Time frame: 1 week

    Participants were asked to monitor stomach bloating after each meal daily during the first week of treatment. The participants that felt having less bloating were recorded to have reduced bloating.

Sponsors and collaborators

Lead sponsor

Immunology Research Institute in Gifu

Industry

Collaborators

  • Dong Do Pharmaceutical Co.

Registry information

Official study title

Evaluation of a Health Food Supplement Containing Anti-Helicobacter Pylori Urease IgY Antibody on Patients With Chronic Gastritis in Hanoi, Vietnam

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 29, 2016
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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