Trial Outcomes & Findings for Immunological Response After Shrimp Oral Immunotherapy Treatment (NCT NCT04552522)

Last Updated: 2026-04-03

Results Overview

Change in the eliciting dose (ED) of shrimp protein during oral food challenge from baseline to 12 months in participants with shrimp allergy undergoing shrimp oral immunotherapy compared with avoidance.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2026-04-03

Participant Flow

aged 12 to 40 years who met three of these criteria: Documented history of immediate allergic reactions within 4 hours of consuming any type of shrimp, with a positive SPT (mean wheal diameter at least 3mm larger than the negative control) or a shrimp-sIgE level ≥ 0.35 KUA/L and positive OFC test for L.Vannamei (2) Willing to consume L. Vannamei despite allergy.

All participants underwent screening OFC before entering to study. Participants were randomly assigned in a 1:1 ratio to either the shrimp OIT group or the avoidance group using block randomization

Participant milestones

Participant milestones
Measure	Intervention Group shrimp OIT for daily oral dosing or to follow an avoidance regimen. The OIT protocol consisted of four phases: (1) Baseline OFC, 2) The dose was increased every 4 weeks until reaching 20 grams of shrimp (approximately three white Pacific shrimps, 71-90 count per pound), providing roughly 7 grams of shrimp protein per shrimp daily. We selected a daily maintenance dose of three shrimps, as the optimal maintenance dose for shrimp OIT has not yet been established. (3) Daily maintenance, and (4) Discontinuation with desensitization assessment. During the build-up phase, doses were increased by 20-50%	Avoidance Group avoid shellfish along study period
Overall Study STARTED	10	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shrimp Allergy With Avoid Shrimp n=10 Participants Case shrimp allergy with avoid shrimp	Shrimp Allergy With Intend to Eat Shrimp n=10 Participants Case shrimp Immunoglobulin E mediated allergy and intend to eat shrimp and start oral immunotherapy for shrimp	Total n=20 Participants Total of all reporting groups
Age, Continuous	17.2 year n=5 Participants • years	14.3 year n=5 Participants • years	16.2 year n=10 Participants • years
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=5 Participants	9 Participants n=10 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=5 Participants	11 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	10 Participants n=5 Participants	20 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Region of Enrollment Thailand	10 Participants n=5 Participants	10 Participants n=5 Participants	20 Participants n=10 Participants
immunological status	4.94 kUA/L n=5 Participants • specific IgE shrimp	24.25 kUA/L n=5 Participants • specific IgE shrimp	9.49 kUA/L n=10 Participants • specific IgE shrimp

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: Participants who completed the 12-month oral food challenge were included in the analysis.

Outcome measures

Outcome measures
Measure	Shrimp Allergy With Intend to Eat Shrimp n=9 Participants Case shrimp Immunoglobulin E mediated allergy and intend to eat shrimp and start oral immunotherapy for shrimp	Shrimp Allergy With Avoid Shrimp n=10 Participants Case shrimp allergy with avoid shrimp
Change in Eliciting Dose of Shrimp During Oral Food Challenge	3233 mg Interval 1400.0 to 9900.0	25 mg Interval -50.0 to 200.0

SECONDARY outcome

Timeframe: 1 year

To follow up adverse event from Shrimp oral immunotherapy

Outcome measures

Outcome data not reported

Adverse Events

Shrimp Allergy With Intend to Eat Shrimp

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Shrimp Allergy With Avoid Shrimp

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Shrimp Allergy With Intend to Eat Shrimp n=10 participants at risk Case shrimp Immunoglobulin E mediated allergy and intend to eat shrimp and start oral immunotherapy for shrimp	Shrimp Allergy With Avoid Shrimp n=10 participants at risk Case shrimp allergy with avoid shrimp
Respiratory, thoracic and mediastinal disorders anaphylaxis	10.0% 1/10 • from enrollment until end of 12 months	40.0% 4/10 • from enrollment until end of 12 months

Other adverse events

Adverse event data not reported

Additional Information

Punchama Pacharn

Mahidol university

Phone: 02-4195670

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place