Trial Outcomes & Findings for Effect of Chicken Egg Antibody (IgY) on Patients With Chronic Gastritis (NCT NCT02721355)

NCT ID: NCT02721355

Last Updated: 2021-01-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 84 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2021-01-28

Participant Flow

Participant milestones

Measure	Food Supplement GastimunHP The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	Control The subjects undergo the routine treatment regime without taking food supplement
Overall Study STARTED	42	42
Overall Study COMPLETED	36	41
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Measure	Food Supplement GastimunHP The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	Control The subjects undergo the routine treatment regime without taking food supplement
Overall Study Lost to Follow-up	6	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Food Supplement GastimunHP n=36 Participants The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	Control n=41 Participants The subjects undergo the routine treatment regime without taking food supplement	Total n=77 Participants Total of all reporting groups
Age, Continuous	48.1 years STANDARD_DEVIATION 12.7 • n=93 Participants	44.2 years STANDARD_DEVIATION 12.5 • n=4 Participants	46.05 years STANDARD_DEVIATION 12.7 • n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	22 Participants n=4 Participants	38 Participants n=27 Participants
Sex: Female, Male Male	20 Participants n=93 Participants	19 Participants n=4 Participants	39 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Food Supplement GastimunHP n=36 Participants The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	Control n=41 Participants The subjects undergo the routine treatment regime without taking food supplement
UBT Values at Baseline and 8 Weeks Baseline	161.64 UBT value Standard Deviation 83.53	158.54 UBT value Standard Deviation 43.73
UBT Values at Baseline and 8 Weeks After 8 weeks	49.42 UBT value Standard Deviation 44.21	73.37 UBT value Standard Deviation 30

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Food Supplement GastimunHP n=36 Participants The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	Control n=41 Participants The subjects undergo the routine treatment regime without taking food supplement
Number of Participants With a Reduction in Severity of Abdominal Pain at 1 and 4 Weeks Reduced pain after 1 week	19 Participants	16 Participants
Number of Participants With a Reduction in Severity of Abdominal Pain at 1 and 4 Weeks Reduced pain after 4 weeks	25 Participants	25 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Food Supplement GastimunHP n=36 Participants The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	Control n=41 Participants The subjects undergo the routine treatment regime without taking food supplement
Number of Participants With a Reduction in Gastrointestinal Symptom Rating Scale (GSRS) Scores at 1 and 4 Weeks Number of participants with reduced GSRS scores after 1 week	18 Participants	15 Participants
Number of Participants With a Reduction in Gastrointestinal Symptom Rating Scale (GSRS) Scores at 1 and 4 Weeks Number of participants with reduced GSRS scores after 4 weeks	25 Participants	25 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Food Supplement GastimunHP n=36 Participants The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	Control n=41 Participants The subjects undergo the routine treatment regime without taking food supplement
Number of Participants With Reduced Bloating After 1 Week	18 Participants	15 Participants

Adverse Events

Food Supplement GastimunHP

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Food Supplement GastimunHP n=36 participants at risk The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime GastimunHP: Health food supplement containing specific IgY against urease of H. pylori	Control n=41 participants at risk The subjects undergo the routine treatment regime without taking food supplement
Gastrointestinal disorders diarrhea	2.8% 1/36 • Number of events 1	0.00% 0/41

Additional Information

Dr. Van Sa Nguyen

Immunology Research Institute in Gifu

Phone: +819068053288

Email: nguyen@ew-nutrition.co.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place