Allergy;FoodPhase 2MOTIFNCT03504774
Food Allergen OIT for Shrimp and Cashew
A Phase 2 study testing Cashew or Shrimp Oral Immunotherapy in people with Allergy;Food and Allergy to Shrimp, run by Sayantani B. Sindher at 1 site in United States.
Trial summary
A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 7 to 55 years with an allergy to either cashew, or shrimp determined by Double Blind-Placebo Controlled-Food Challenge… Read more about this study
- Who is it for?
- Ages 7 to 55 years
- Conditions the study is for
- Allergy;Food, Allergy to Shrimp, Allergy to Cashew Nut (Disorder)
- What is being tested?
- Cashew or Shrimp Oral Immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2019to 3 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject and/or parent guardian must be able to understand and provide informed consent
- Age 7 through 55 years (inclusive)
- Clinical history of allergy to cashew or shrimp-containing foods
- Serum IgE to cashew or shrimp of ≥0.35 kUA/L [determined by UniCAPTM within the past 12 months] and/or a SPT to cashew or shrimp ≥3 mm compared to control
- Experience dose-limiting symptoms at or before the 300 mg challenge dose of FA protein on Screening DBPCFC conducted in accordance with PRACTALL guidelines
- Written informed consent from adult participants
Show all 10Show fewer
- Written informed consent from parent/guardian for minor participants
- Written assent from minor participants as appropriate (e.g., above the age of 7 years or the applicable age per local regulatory requirements)
- All female subjects of child-bearing potential will be required to provide a blood or urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study.
- Use of effective birth control by female participants of child-bearing potential.
Who cannot join
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- History of uncontrolled cardiovascular disease, including uncontrolled hypertension
- History of other chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) requiring therapy (e.g., heart disease, diabetes) that is, or is at significant risk of becoming unstable or requiring a change in chronic therapeutic regimen and, in the opinion of the Principal Investigator, would represent a risk to the subject's health or safety in this study or the subject's ability to comply with the study protocol.
- History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD) grade 3 according to CTCAE version 5.0, symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology
- Current participation in any other interventional study
- Subject is currently in the build-up phase of immunotherapy to another allergen and is on maintenance immunotherapy dose for any allergen related to cashew or shrimp
Show all 19Show fewer
- Severe asthma (NAEPP EPR-3 Medication Criteria Steps 5 or 6)
- Mild or moderate asthma (NAEPP EPR-3 Medication Criteria Steps 1-4), if not controlled as indicated by an ACT<19
- A hospitalization for asthma in the past 6 months
- ER visit for asthma within the past 6 months
- Burst or steroid course for asthma in the past 6 months
- Use of omalizumab or biologic therapy (e.g., infliximab, rituximab, etc.) within the past 6 months
- Use of complementary and alternative medicine (CAM) treatment modalities (e.g., herbal remedies) for atopic and /or non-atopic disease within 90 days preceding Initial Dose Escalation Day (IDED) or at any time after the IDED
- Use of beta-blockers (oral)
- Pregnancy or lactation
- Allergy to oat
- History of severe anaphylaxis to cashew or shrimp with symptoms including hypotension requiring fluid resuscitation and/or the need for mechanical ventilation within the last year
- Use of investigational drugs within 12 weeks of participation
- Past or current medical problems or findings from physical assessment or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Sean N Parker Center For Allergy and Asthma Research
Palo Alto, California, 94304
About this study
Official title: T Cell Reagent Research for Monitoring T Cells in Food Allergy (MOTIF) Phase 2 Study Using Food Allergen Oral Immunotherapy for Shrimp or Cashew Allergies
A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 7 to 55 years with an allergy to either cashew, or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT).
Read the detailed description
A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 7 to 55 years with an allergy to either cashew or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT). Enrolled participants must be positive at or before the 300 mg (443 mg cumulative) dosing level of FA protein. OIT treatment groups will be cashew or shrimp.
All cohorts will undergo an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC. Participants that pass their food challenge with no or mild objective reactions to up to a cumulative 2043 mg of the FA allergen in their OIT at the end of this phase (primary outcome) will be considered desensitized and have successfully met the primary endpoint.
All participants then will continue in the study by undergoing withdrawal from OIT for 6 weeks to examine mechanisms underlying sustained responsiveness (SU) which will be defined as a participant's passing a DBPCFC with no or mild objective reaction to up to a cumulative 2043 mg of the FA allergen in their DBPCFC at week 58.
Those participants who pass the Week 58 challenge up to a cumulative of 2043 mg will be given the option to continue the withdrawal phase up to Week 64 which will be end of study. Week 58 will be end of study for those who do not opt for this continuation of withdrawal.
- Being tested
- Cashew or Shrimp Oral Immunotherapy
- Keywords
- OIT, Oral Immunotherapy, Cashew Allergy, Shrimp Allergy
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cashew or Shrimp Oral ImmunotherapyDrug
Also called OIT
All cohorts will undergo an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC.
| Study group | Role | What they receive |
|---|---|---|
| Cashew or Shrimp Oral Immunotherapy | Experimental | Participants, ages 7 to 55 years, inclusive, with an allergy to Cashew or Shrimp. Receives: Drug: Cashew or Shrimp Oral Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of CD28 in the CD4+ Allergen Specific (CD154+)
Expression of CD28 in the CD4+ allergen specific (CD154+) T-cells at baseline and 52 weeks, reported as the percentage of allergen specific (reactive) cells.
Measured: baseline and 52 week
Secondary outcomes (3)
Expression of CD28+ Allergen Specific (CD154+) T-cells
Expression of CD28+ allergen specific (CD154+) T-cells at baseline, week 52, and week 58, reported as the percentage of allergen specific (reactive) cells.
Measured: baseline, week 52 and week 58
Expression of the Mechanistic Markers Vis Luminex Assay
Expression of the following measures in CD4+CD28+ allergen specific (CD154+) T-cells at baseline, week 52, and week 58. Data were collected for IFN-gamma, IL-4 and IL-10 via Luminex assay. Data collection was planned for receptor diversity in allergen specific T cell CDR3b as compared to non-specific T cells, and TGF beta, but these data were not collected. The median value (with full range) of mean fluorescence intensity across participants is reported for each time point.
Measured: baseline, week 52, and week 58
Expression of the Mechanistic Marker Via Flow Cytometry
Expression of the following measures in CD4+CD28+ allergen specific (CD154+) T-cells at baseline, week 52, and week 58. Data were collected for GPR15 via flow cytometry resulting in mean fluorescence intensity. Data collection was planned for receptor diversity in allergen specific T cell CDR3b as compared to non-specific T cells, and TGF beta, but these data were not collected. The median value (with full range) of mean fluorescence intensity across participants is reported for each time point.
Measured: baseline, week 52, and week 58
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start9 Jul 2019
- Primary completion13 Jan 2023
- Study completion3 Mar 2023
Why it stopped: Study discontinued due to slow enrollment during COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Allergy;FoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Food allergy OIT in a single group design
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sayantani B. Sindher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sayantani B. Sindher, Stanford University
- Investigators
- Sayantani Sindher, MD, Study director, Stanford University, SNP Center for Food Allergy and Asthma Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504774
- Sponsor's protocol ID
- IRB-48330
- Other IDs
- 1U01AI140498-01
- Acronym
- MOTIF
- Status last verified
- Mar 2024
- First submitted
- 3 Apr 2018
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sindher SB, Fernandes A, Manohar M, Cao S, Gupta S, Parsons E, Bogetic D, Kumar D, Rogers J, Thompson J, Dunham D, Do E, Maysel-Auslender S, Liu TA, Martinez K, Anderson B, Kaushik A, Desai M, Maecker H, Perry S, Wheatley LM, Nadeau KC, Chinthrajah RS. Trends in allergen-reactive CRTH2+ T cells and TARC associated with successful outcomes in a phase 2 cashew oral immunotherapy study. Front Immunol. 2025 Oct 22;16:1655975. doi: 10.3389/fimmu.2025.1655975. eCollection 2025.
PubMed 41200192Jiang SY, Cao S, Martinez K, Sharma R, Raeber O, Fernandes A, Bogetic D, Kaushik A, Gupta S, Manohar M, Maeker HT, Chin AR, Long AJ, Feight C, Woch M, Nadeau KC, Chinthrajah RS, Sindher SB. Shrimp oral immunotherapy outcomes in the phase 2 clinical trial: MOTIF. Front Allergy. 2025 Jul 22;6:1458131. doi: 10.3389/falgy.2025.1458131. eCollection 2025.
PubMed 40766832
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T Cell Reagent Research for Monitoring T Cells in Food Allergy (MOTIF) Phase 2 Study Using Food Allergen Oral Immunotherapy for Shrimp or Cashew Allergies
- ClinicalTrials.gov ID
- NCT03504774
- Acronym / sponsor ID
- MOTIF / IRB-48330
- Keywords
- OIT, Oral Immunotherapy, Cashew Allergy, Shrimp Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study discontinued due to slow enrollment during COVID-19 pandemic
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sayantani B. SindherUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 7 to 55 years with an allergy to either cashew, or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT).
Detailed description
A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 7 to 55 years with an allergy to either cashew or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT). Enrolled participants must be positive at or before the 300 mg (443 mg cumulative) dosing level of FA protein. OIT treatment groups will be cashew or shrimp.
All cohorts will undergo an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC. Participants that pass their food challenge with no or mild objective reactions to up to a cumulative 2043 mg of the FA allergen in their OIT at the end of this phase (primary outcome) will be considered desensitized and have successfully met the primary endpoint.
All participants then will continue in the study by undergoing withdrawal from OIT for 6 weeks to examine mechanisms underlying sustained responsiveness (SU) which will be defined as a participant's passing a DBPCFC with no or mild objective reaction to up to a cumulative 2043 mg of the FA allergen in their DBPCFC at week 58.
Those participants who pass the Week 58 challenge up to a cumulative of 2043 mg will be given the option to continue the withdrawal phase up to Week 64 which will be end of study. Week 58 will be end of study for those who do not opt for this continuation of withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Food allergy OIT in a single group design
| Arm | Type | Receives |
|---|---|---|
| Cashew or Shrimp Oral Immunotherapy | Experimental | Drug: Cashew or Shrimp Oral ImmunotherapyParticipants, ages 7 to 55 years, inclusive, with an allergy to Cashew or Shrimp. |
Who may qualify
- Ages
- 7 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Subject and/or parent guardian must be able to understand and provide informed consent
- Age 7 through 55 years (inclusive)
- Clinical history of allergy to cashew or shrimp-containing foods
- Serum IgE to cashew or shrimp of ≥0.35 kUA/L [determined by UniCAPTM within the past 12 months] and/or a SPT to cashew or shrimp ≥3 mm compared to control
- Experience dose-limiting symptoms at or before the 300 mg challenge dose of FA protein on Screening DBPCFC conducted in accordance with PRACTALL guidelines
Key exclusion criteria (19 listed)
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- History of uncontrolled cardiovascular disease, including uncontrolled hypertension
- History of other chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) requiring therapy (e.g., heart disease, diabetes) that is, or is at significant risk of becoming unstable or requiring a change in chronic therapeutic regimen and, in the opinion of the Principal Investigator, would represent a risk to the subject's health or safety in this study or the subject's ability to comply with the study protocol.
- History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD) grade 3 according to CTCAE version 5.0, symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology
- Current participation in any other interventional study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cashew or Shrimp Oral ImmunotherapyAlso: OITAll cohorts will undergo an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC. | Drug | Cashew or Shrimp Oral Immunotherapy |
Primary outcome
Expression of CD28 in the CD4+ Allergen Specific (CD154+)
Time frame: baseline and 52 week
Expression of CD28 in the CD4+ allergen specific (CD154+) T-cells at baseline and 52 weeks, reported as the percentage of allergen specific (reactive) cells.
3 secondary outcomes
Expression of CD28+ Allergen Specific (CD154+) T-cells
Time frame: baseline, week 52 and week 58
Expression of the Mechanistic Markers Vis Luminex Assay
Time frame: baseline, week 52, and week 58
Expression of the Mechanistic Marker Via Flow Cytometry
Time frame: baseline, week 52, and week 58
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41200192Sindher SB, Fernandes A, Manohar M, Cao S, Gupta S, Parsons E, Bogetic D, Kumar D, Rogers J, Thompson J, Dunham D, Do E, Maysel-Auslender S, Liu TA, Martinez K, Anderson B, Kaushik A, Desai M, Maecker H, Perry S, Wheatley LM, Nadeau KC, Chinthrajah RS. Trends in allergen-reactive CRTH2+ T cells and TARC associated with successful outcomes in a phase 2 cashew oral immunotherapy study. Front Immunol. 2025 Oct 22;16:1655975. doi: 10.3389/fimmu.2025.1655975. eCollection 2025.
- Results publication: PubMed 40766832Jiang SY, Cao S, Martinez K, Sharma R, Raeber O, Fernandes A, Bogetic D, Kaushik A, Gupta S, Manohar M, Maeker HT, Chin AR, Long AJ, Feight C, Woch M, Nadeau KC, Chinthrajah RS, Sindher SB. Shrimp oral immunotherapy outcomes in the phase 2 clinical trial: MOTIF. Front Allergy. 2025 Jul 22;6:1458131. doi: 10.3389/falgy.2025.1458131. eCollection 2025.
- Sean N. Parker Center for Allergy and Asthma ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Allergy;Food
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
RecruitingPhase 4
Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy
Food Allergy
Active, not recruiting
Slow Multiallergen Oral Immunotherapy in Young Children
Food Allergy, Oral Immunotherapy for Food Allergy
Not yet recruiting
Immunotherapy for Curing Toddlers With Severe Food Allergy - a Paradigm Shift From Passive to Active Treatment With Multi-allergen Oral Immunotherapy
Food Allergy in Children
Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayantani Sindher, MD study director
Stanford University, SNP Center for Food Allergy and Asthma Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cashew or Shrimp Oral Immunotherapy in people with Allergy;Food and Allergy to Shrimp, run by Sayantani B. Sindher at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of CD28 in the CD4+ Allergen Specific (CD154+) (time frame: baseline and 52 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03504774, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.