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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Immunology Research Institute in Gifu

Current Primary Outcome: Effect of IgY in combination with EAC on Helicobacter pylori eradication in patients with chronic gastritis [ Time Frame: 4 weeks ]

Urea Breath test (UBT) value was examined at baseline and 4 weeks after initiation of treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effect of IgY in combination with EAC on severity of abdominal pain. [ 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).
  • Effect of IgY in combination with EAC on nausea and vomiting [ 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)
  • Effect of IgY in combination with EAC on bloating [ Time Frame: 4 weeks ]
    Outcome measures are the Gastrointestinal Symptom Rating Scale (GSRS) scores using a four-point graded scale (0 = no or transient distension; 1 = occasional discomfort of short duration; 2 = frequent and prolonged episodes which can be mastered by adjusting the clothing; 3 = continuous discomfort seriously interfering with social performance)


Original Secondary Outcome: Same as current

Information By: Immunology Research Institute in Gifu

Dates:
Date Received: March 3, 2016
Date Started: June 2013
Date Completion:
Last Updated: August 29, 2016
Last Verified: August 2016