Peanut AllergyPAID-UPNCT02698033
High Threshold Peanut Challenge Study
An observational study of Peanut Allergy, run by Massachusetts General Hospital.
Trial summary
This protocol is designed to better characterize a sub-population of peanut sensitized individuals who may be non-allergic, despite significant sensitization, or who may be allergic, but at high threshold doses. Read more about this study
- Who is it for?
- Ages 7 to 55 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Peanut flour and Toasted oat flour
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2015to 22 Aug 2019
- Phase
- Observational
- 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
Study population: A sub-population of peanut sensitized individuals who may be non-allergic, despite significant sensitization, or who may be allergic, but at high threshold doses.
Who may be able to join
- Failure to react to 443 mg of peanut protein during the DBPCFC1 visit of protocol 2012p002153 / AADCRC MGH-004.
- Males and females of all ethnic/racial groups aged 7-55 years old who are otherwise healthy.
- Willingness to sign consent (or for parent/guardian to sign consent).
- Willingness to sign the assent form, if consent provided by parent/guardian.
Who cannot join
- History of severe anaphylaxis
- Severe or Moderate asthma
- Poorly controlled asthma
- Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions
- Inability to cooperate with and/or perform oral food challenge procedures
- Primary Immune Deficiency
Show all 13Show fewer
- Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors
- Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
- Use within the past 6 months of other systemic immunomodulatory treatments
- Clinical signs or symptoms of anemia
- Hematocrit <0.36 for adult females or <0.38 for adult males
- Hematocrit <0.34 for children 7-18 years of age
- Weight <23 kg
About this study
Official title: Follow-Up Protocol For Peanut Allergic Individuals With Documented Objective Clinical Unresponsiveness to a Double-Blind Placebo-Controlled Food Challenge With Peanut Protein
This protocol is designed to better characterize a sub-population of peanut sensitized individuals who may be non-allergic, despite significant sensitization, or who may be allergic, but at high threshold doses. By specifically targeting participants who met the initial screening criteria of the active adult PN OIT study, Protocol 2012p002153 / AADCRC MGH-004 (MGH-004), but failed to react during the pre-treatment 443 mg challenge to peanut, the investigators anticipate that the investigators will identify individuals who have become spontaneously tolerant, despite persistent sensitization. The investigators might also find that clinical sensitivity persists but only with higher thresholds, or that sensitivity has increased (or is variable) since the previous allergen exposure. By repeating DBPCFCs through to a full serving dose (7.4 gram), the investigators will distinguish participants who react only at higher doses from those who were not truly peanut allergic, address whether their sensitivity has changed, and have the opportunity to further investigate their immune response to peanut allergen.
Read the detailed description
The primary objective of the study is to identify and characterize a sub-population of high-threshold peanut allergic individuals and characterize their immunological phenotype in comparison with the low-threshold peanut allergic individuals enrolled in the adult PN OIT study (NCT01750879).
Clinical Objective:
To evaluate the clinical status of peanut-sensitized individuals previously passing a DBPCFC to 443 mg as being either: non-allergic, stably high-threshold allergic or more clinically reactive on repeat exposure.
- Conditions
- Peanut Allergy
- Being tested
- Peanut flour, Toasted oat flour
- Keywords
- food allergy, peanut, food challenge
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut flourDrug
A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
Toasted oat flourOther
A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
| Study group | Role | What they receive |
|---|---|---|
| Low dose challenge passed | Individuals who tolerated without dose limiting symptoms the screening food challenge for a parent interventional trial Receives: Drug: Peanut flour; Other: Toasted oat flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency of High Threshold Reactivity
The proportion of high-threshold peanut allergic individuals among participants who previously failed to react to a 443 mg peanut protein challenge in NCT01750879 who also reacted >443 cumulative total dose on repeat challenge
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study start9 Dec 2015
- Primary completion7 Jul 2016
- Study completion22 Aug 2019
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.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital
- Investigators
- Wayne G Shreffler, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698033
- Sponsor's protocol ID
- 2015P001519
- Other IDs
- 5U19AI095261-02
- Acronym
- PAID-UP
- Status last verified
- Oct 2019
- First submitted
- 29 Jan 2016
- Last updated
- 3 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-Up Protocol For Peanut Allergic Individuals With Documented Objective Clinical Unresponsiveness to a Double-Blind Placebo-Controlled Food Challenge With Peanut Protein
- ClinicalTrials.gov ID
- NCT02698033
- Acronym / sponsor ID
- PAID-UP / 2015P001519
- Conditions
- Peanut Allergy
- Keywords
- food allergy, peanut, food challenge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 9 Dec 2015 (actual)
- Primary completion
- 7 Jul 2016 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is designed to better characterize a sub-population of peanut sensitized individuals who may be non-allergic, despite significant sensitization, or who may be allergic, but at high threshold doses. By specifically targeting participants who met the initial screening criteria of the active adult PN OIT study, Protocol 2012p002153 / AADCRC MGH-004 (MGH-004), but failed to react during the pre-treatment 443 mg challenge to peanut, the investigators anticipate that the investigators will identify individuals who have become spontaneously tolerant, despite persistent sensitization. The investigators might also find that clinical sensitivity persists but only with higher thresholds, or that sensitivity has increased (or is variable) since the previous allergen exposure. By repeating DBPCFCs through to a full serving dose (7.4 gram), the investigators will distinguish participants who react only at higher doses from those who were not truly peanut allergic, address whether their sensitivity has changed, and have the opportunity to further investigate their immune response to peanut allergen.
Detailed description
The primary objective of the study is to identify and characterize a sub-population of high-threshold peanut allergic individuals and characterize their immunological phenotype in comparison with the low-threshold peanut allergic individuals enrolled in the adult PN OIT study (NCT01750879).
Clinical Objective:
To evaluate the clinical status of peanut-sensitized individuals previously passing a DBPCFC to 443 mg as being either: non-allergic, stably high-threshold allergic or more clinically reactive on repeat exposure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low dose challenge passed | – | Drug: Peanut flour, Other: Toasted oat flourIndividuals who tolerated without dose limiting symptoms the screening food challenge for a parent interventional trial |
Who may qualify
- Ages
- 7 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A sub-population of peanut sensitized individuals who may be non-allergic, despite significant sensitization, or who may be allergic, but at high threshold doses.
Key inclusion criteria (4 listed)
- Failure to react to 443 mg of peanut protein during the DBPCFC1 visit of protocol 2012p002153 / AADCRC MGH-004.
- Males and females of all ethnic/racial groups aged 7-55 years old who are otherwise healthy.
- Willingness to sign consent (or for parent/guardian to sign consent).
- Willingness to sign the assent form, if consent provided by parent/guardian.
Key exclusion criteria (13 listed)
- History of severe anaphylaxis
- Severe or Moderate asthma
- Poorly controlled asthma
- Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions
- Inability to cooperate with and/or perform oral food challenge procedures
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 |
|---|---|---|
| Peanut flourA Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly. | Drug | Low dose challenge passed |
| Toasted oat flourA Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly. | Other | Low dose challenge passed |
Primary outcome
Consistency of High Threshold Reactivity
Time frame: 4 weeks
The proportion of high-threshold peanut allergic individuals among participants who previously failed to react to a 443 mg peanut protein challenge in NCT01750879 who also reacted >443 cumulative total dose on repeat challenge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Wayne G Shreffler, MD, PhD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Peanut Allergy, run by Massachusetts General Hospital.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2019). 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?
Consistency of High Threshold Reactivity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2019.