Peanut AllergyNCT05165329
A Randomized, Controlled Trial of Probiotic and Peanut Oral Immunotherapy (PPOIT) in Inducing Tolerance in Hong Kong Children With Peanut Allergy Compared With Oral Immunotherapy (OIT) Alone and With Placebo
A study testing PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations in people with Peanut Allergy and Food Allergy in Children, run by Chinese University of Hong Kong at 4 sites in Hong Kong.
Trial summary
At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe. However we know that accidental exposure is common. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Peanut Allergy, Food Allergy in Children
- What is being tested?
- PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesHong Kong
- Study dates
- 11 Nov 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria: Subjects are eligible if they meet all of the following criteria
- Aged between 1 year and 17 years of age;
- >=7kg (the weight considered safe for administration of adrenaline autoinjector (e.g. Jext);
- Ethnic Chinese; and
- Confirmed diagnosis of peanut allergy as defined by a failed double-blind placebo-controlled food challenge (DBPCFC) with peanut and a serum peanut-specific IgE level of at least 0.35 kUA (allergen-specific unit) per liter according to ImmunoCAP (Thermo Fisher Scientific) at screening.
Exclusion Criteria: Subjects are not eligible if they meet any of the following criteria
- History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing >3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction);
- Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring >3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction);
- FEV1 <85% at rest and FEV1/FVC ≤ 85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines);
- Underlying medical conditions (e.g. cardiac disease) that increase the risks for anaphylaxis;
- Use of beta-blockers, and ACE inhibitors;
- Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immunocompromised states, post-cardiac and/or gastrointestinal tract surgery, critically-ill or other conditions that may increase the risks of probiotic associated sepsis;
- Already taking probiotic supplements or foods containing probiotics within the past month;
- Reacting to the placebo component during the study entry DBPCFC;
- Have received other food immunotherapy treatment in the preceding 12 months;
- History of suspected or biopsy-confirmed eosinophilic esophagitis (EoE);
- Currently taking immunomodulatory therapy (including allergen immunotherapy);
- Past or current major illness that in the opinion of the Site Investigator may affect the subject's ability to participate in the study e.g. increased risk to the participant;
- Subjects who in the opinion of the Site Investigator are unable to follow the protocol;
- Another family member already enrolled in the trial (to maintain safety and blinding); or
- Non-English and non-Chinese speaking participants and their families. NOTE: participants with other food allergies are NOT excluded from participating in this trial.
Trial locations and contacts
4 sites in 1 country.
Hong Kong4 sites
Department of Paediatrics and Adolescent Medicine, Hong Kong Children's Hospital
Hong Kong
Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital
Hong Kong
Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Department of Paediatrics, Queen Elizabeth Hospital
Hong Kong
About this study
Official title: A Randomised, Controlled Trial Evaluating the Effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in Inducing Desensitisation or Remission in Chinese Children With Peanut Allergy Compared With Oral Immunotherapy (OIT) Alone and With Placebo
At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe. However we know that accidental exposure is common. Researchers have begun to look at the effectiveness of 'oral immunotherapy' as a treatment for food allergy but results have been mixed.
This study is a randomized controlled trial to evaluate the effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with Placebo. Children will take increasing doses of peanut protein and a set amount of probiotic until a total of 18 months treatment is completed. Children will be tested for peanut allergy at the start of the study, at the end of PPOIT treatment T1 (18 months) and T2 (8 weeks) and T3 (1year) after treatment.
Read the detailed description
This is a three-armed, randomised (4:4:1), stratified (by age), blinded, placebo-controlled, parallel-group, superiority trial.
- PPOIT Probiotic and peanut OIT taken daily for 18 months.
- OIT Probiotic placebo and peanut OIT taken daily for 18 months.
- Placebo Probiotic placebo and OIT placebo taken daily for 18 months.
The study consists of:
Screening visit occurs within three months before Day 1.
Day 1 Rush Induction Phase is the start of treatment where participants receive increasing doses of peanut (or placebo) OIT every 20 minutes to reach a final dose of 12mg of peanut protein (or placebo). A single dose of 2x10^10 cfu Lactobacillus rhamnosus GG (or placebo) is also taken.
Week 1 - 16 is the Buildup Phase where the daily dose of peanut (or placebo) OIT is increased every 2 weeks* until a maintenance dose of 2000mg peanut protein (or placebo) is reached. This is expected to take 16 weeks. A fixed daily dose of 2x10^10 cfu Lactobacillus rhamnosus GG (or placebo) is taken during this phase.
- In unavoidable circumstances i.e. school camps, examinations, when scheduling must be amended depending on parents/ participants availability, the window for buildup visits can be +/- 7 days.
Week 16 - 78 is the Maintenance Phase where participants take a daily dose of 2g of peanut protein (or placebo) and a daily dose of 2x10^10 cfu Lactobacillus rhamnosus GG (or placebo) at home and continue until a total of 18 months of treatment is completed.
Week 78 - 86 is the Elimination Phase where participants continue on a peanut-elimination diet post-treatment.
Week 86 -130 is the Monitoring Phase: All groups will be followed up for 12 months after the treatment period. During this time, at 6 months, a telephone interview will be conducted with the participant's parent or guardian to collect information on exposure to peanut/amount of peanut being eaten and allergic reactions.
The primary outcome analysis will be conducted when all subjects have either completed the T2 DBPCFC or terminated the study prior to their T2 visit. Analysis of safety and tolerability, and other secondary outcomes to the T2 timepoint will also be conducted at this time. A supplemental analysis will be conducted at the end of study (i.e. when last subject completes T3 or has withdrawn from the study prior to their T3 visit, or sponsor terminates the study), using cumulative data from the study.
- Conditions
- Peanut Allergy, Food Allergy in Children
- Being tested
- PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations, PEANUT PLACEBO: Peanut Placebo is maltodextrin powder with food colouring and peanut essence that has similar appearance, taste and smell to the active product.
- Keywords
- peanut allergy; oral immunotherapy; sustained unresponsiveness; tolerance
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulationsCombination product
PROBIOTIC: The probiotic to be used is Lactobacillus rhamnosus GG, supplied as a freeze-dried powder. Probiotic will be prepared under strict Food Manufacturing Regulations. The daily dose of 2x10^10 cfu will be packed individually in sachets. Participants will be instructed to mix one scoop of the probiotic in water at a temperature NOT exceeding 38 degrees Celsius. The probiotic must be stored at 4 degrees Celsius
PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulationsCombination product
PROBIOTIC PLACEBO: Probiotic Placebo is maltodextrin. The daily dose will be measured using a standardised scoop. Participants will be instructed to mix one scoop of the probiotic in water at a temperature NOT exceeding 38 degrees Celsius. The probiotic should be stored at 2-8 degrees Celsius.
PEANUT PLACEBO: Peanut Placebo is maltodextrin powder with food colouring and peanut essence that has similar appearance, taste and smell to the active product.Combination product
PROBIOTIC PLACEBO: Probiotic Placebo is maltodextrin. The daily dose will be measured using a standardised scoop. Participants will be instructed to mix one scoop of the probiotic in water at a temperature NOT exceeding 38 degrees Celsius. The probiotic should be stored at 2-8 degrees Celsius.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic and Peanut Oral Immunotherapy (PPOIT) | Active comparator | Probiotic and peanut oral immunotherapy taken daily for 18 months Receives: Combination Product: PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations |
| Placebo Probiotic and Peanut Oral Immunotherapy | Active comparator | Placebo probiotic and peanut oral immunotherapy taken daily for 18 months Receives: Combination Product: PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations |
| Placebo Probiotic and Placebo Oral Immunotherapy | Placebo comparator | Placebo probiotic and placebo oral immunotherapy taken daily for 18 months Receives: Combination Product: PEANUT PLACEBO: Peanut Placebo is maltodextrin powder with food colouring and peanut essence that has similar appearance, taste and smell to the active product. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in PPOIT vs placebo
Measured: T2 - 8 weeks after final day of maintenance treatment
Secondary outcomes (5)
Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in PPOIT vs peanut OIT.
Measured: T2 - 8 weeks after final day of maintenance treatment
Proportion of participants who achieve full desensitisation (passed T1 challenge) in: (i) PPOIT vs placebo and (ii) PPOIT vs OIT; and (iii) OIT vs placebo.
Measured: T1 - One Day after final day of maintenance treatment
The cumulative dose tolerated during the T1 challenge in: (i) PPOIT vs placebo and (ii) PPOIT vs OIT; and (iii) OIT vs placebo.
Cumulative doses below the reaction-eliciting dose if there is a reaction; or total cumulative challenge dose if there is no reaction
Measured: T1 - One Day after final day of maintenance treatment
Peanut SPT wheal size and peanut and peanut component (Ara h 1, Ara h 2, Ara h 3) sIgE and sIgG4 levels in: (i) PPOIT vs placebo; (ii) PPOIT vs OIT; and (iii) OIT vs placebo and their correlation with sustained unresponsiveness.
Measured: At 12 months of treatment; T1 - One Day after final day of maintenance treatment. T2 - 8 weeks after final day of maintenance treatment
Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in (i) PPOIT vs placebo; and (ii) PPOIT vs OIT; and (iii) OIT vs placebo groups.
Measured: TEAEs will be collected until T2 - 8 weeks after final day of maintenance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start11 Nov 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting-fan Leung, Chinese University of Hong Kong
- Investigators
- Ting Fan Leung, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165329
- Sponsor's protocol ID
- PPOIT-HK
- Status last verified
- Feb 2024
- First submitted
- 8 Dec 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled Trial Evaluating the Effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in Inducing Desensitisation or Remission in Chinese Children With Peanut Allergy Compared With Oral Immunotherapy (OIT) Alone and With Placebo
- ClinicalTrials.gov ID
- NCT05165329
- Acronym / sponsor ID
- PPOIT-HK
- Conditions
- Peanut Allergy, Food Allergy in Children
- Keywords
- peanut allergy; oral immunotherapy; sustained unresponsiveness; tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe. However we know that accidental exposure is common. Researchers have begun to look at the effectiveness of 'oral immunotherapy' as a treatment for food allergy but results have been mixed.
This study is a randomized controlled trial to evaluate the effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with Placebo. Children will take increasing doses of peanut protein and a set amount of probiotic until a total of 18 months treatment is completed. Children will be tested for peanut allergy at the start of the study, at the end of PPOIT treatment T1 (18 months) and T2 (8 weeks) and T3 (1year) after treatment.
Detailed description
This is a three-armed, randomised (4:4:1), stratified (by age), blinded, placebo-controlled, parallel-group, superiority trial.
- PPOIT Probiotic and peanut OIT taken daily for 18 months.
- OIT Probiotic placebo and peanut OIT taken daily for 18 months.
- Placebo Probiotic placebo and OIT placebo taken daily for 18 months.
The study consists of:
Screening visit occurs within three months before Day 1.
Day 1 Rush Induction Phase is the start of treatment where participants receive increasing doses of peanut (or placebo) OIT every 20 minutes to reach a final dose of 12mg of peanut protein (or placebo). A single dose of 2x10^10 cfu Lactobacillus rhamnosus GG (or placebo) is also taken.
Week 1 - 16 is the Buildup Phase where the daily dose of peanut (or placebo) OIT is increased every 2 weeks* until a maintenance dose of 2000mg peanut protein (or placebo) is reached. This is expected to take 16 weeks. A fixed daily dose of 2x10^10 cfu Lactobacillus rhamnosus GG (or placebo) is taken during this phase.
- In unavoidable circumstances i.e. school camps, examinations, when scheduling must be amended depending on parents/ participants availability, the window for buildup visits can be +/- 7 days.
Week 16 - 78 is the Maintenance Phase where participants take a daily dose of 2g of peanut protein (or placebo) and a daily dose of 2x10^10 cfu Lactobacillus rhamnosus GG (or placebo) at home and continue until a total of 18 months of treatment is completed.
Week 78 - 86 is the Elimination Phase where participants continue on a peanut-elimination diet post-treatment.
Week 86 -130 is the Monitoring Phase: All groups will be followed up for 12 months after the treatment period. During this time, at 6 months, a telephone interview will be conducted with the participant's parent or guardian to collect information on exposure to peanut/amount of peanut being eaten and allergic reactions.
The primary outcome analysis will be conducted when all subjects have either completed the T2 DBPCFC or terminated the study prior to their T2 visit. Analysis of safety and tolerability, and other secondary outcomes to the T2 timepoint will also be conducted at this time. A supplemental analysis will be conducted at the end of study (i.e. when last subject completes T3 or has withdrawn from the study prior to their T3 visit, or sponsor terminates the study), using cumulative data from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic and Peanut Oral Immunotherapy (PPOIT) | Active comparator | Combination Product: PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulationsProbiotic and peanut oral immunotherapy taken daily for 18 months |
| Placebo Probiotic and Peanut Oral Immunotherapy | Active comparator | Combination Product: PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulationsPlacebo probiotic and peanut oral immunotherapy taken daily for 18 months |
| Placebo Probiotic and Placebo Oral Immunotherapy | Placebo comparator | Combination Product: PEANUT PLACEBO: Peanut Placebo is maltodextrin powder with food colouring and peanut essence that has similar appearance, taste and smell to the active product.Placebo probiotic and placebo oral immunotherapy taken daily for 18 months |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulationsPROBIOTIC: The probiotic to be used is Lactobacillus rhamnosus GG, supplied as a freeze-dried powder. Probiotic will be prepared under strict Food Manufacturing Regulations. The daily dose of 2x10^10 cfu will be packed individually in sachets. Participants will be instructed to mix one scoop of the probiotic in water at a temperature NOT exceeding 38 degrees Celsius. The probiotic must be stored at 4 degrees Celsius | Combination product | Probiotic and Peanut Oral Immunotherapy (PPOIT) |
| PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulationsPROBIOTIC PLACEBO: Probiotic Placebo is maltodextrin. The daily dose will be measured using a standardised scoop. Participants will be instructed to mix one scoop of the probiotic in water at a temperature NOT exceeding 38 degrees Celsius. The probiotic should be stored at 2-8 degrees Celsius. | Combination product | Placebo Probiotic and Peanut Oral Immunotherapy |
| PEANUT PLACEBO: Peanut Placebo is maltodextrin powder with food colouring and peanut essence that has similar appearance, taste and smell to the active product.PROBIOTIC PLACEBO: Probiotic Placebo is maltodextrin. The daily dose will be measured using a standardised scoop. Participants will be instructed to mix one scoop of the probiotic in water at a temperature NOT exceeding 38 degrees Celsius. The probiotic should be stored at 2-8 degrees Celsius. | Combination product | Placebo Probiotic and Placebo Oral Immunotherapy |
Primary outcome
Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in PPOIT vs placebo
Time frame: T2 - 8 weeks after final day of maintenance treatment
5 secondary outcomes
Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in PPOIT vs peanut OIT.
Time frame: T2 - 8 weeks after final day of maintenance treatment
Proportion of participants who achieve full desensitisation (passed T1 challenge) in: (i) PPOIT vs placebo and (ii) PPOIT vs OIT; and (iii) OIT vs placebo.
Time frame: T1 - One Day after final day of maintenance treatment
The cumulative dose tolerated during the T1 challenge in: (i) PPOIT vs placebo and (ii) PPOIT vs OIT; and (iii) OIT vs placebo.
Time frame: T1 - One Day after final day of maintenance treatment
Peanut SPT wheal size and peanut and peanut component (Ara h 1, Ara h 2, Ara h 3) sIgE and sIgG4 levels in: (i) PPOIT vs placebo; (ii) PPOIT vs OIT; and (iii) OIT vs placebo and their correlation with sustained unresponsiveness.
Time frame: At 12 months of treatment; T1 - One Day after final day of maintenance treatment. T2 - 8 weeks after final day of maintenance treatment
Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in (i) PPOIT vs placebo; and (ii) PPOIT vs OIT; and (iii) OIT vs placebo groups.
Time frame: TEAEs will be collected until T2 - 8 weeks after final day of maintenance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Related InfoLink provided by the sponsor.
- 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.
Ting Fan Leung principal investigator
Chinese University of Hong Kong
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations in people with Peanut Allergy and Food Allergy in Children, run by Chinese University of Hong Kong at 4 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in PPOIT vs placebo (time frame: T2 - 8 weeks after final day of maintenance treatment). 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 8 Feb 2024.