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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Year - 17 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05165329
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chinese University of Hong Kong
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ting Fan Leung
Principal Investigator Affiliation Department of Paediatrics, The Chinese University of Hong Kong
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Hong Kong
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy, Food Allergy in Children
Study Website: View Trial Website
Additional Details

This is a three-armed, randomised (4:4:1), stratified (by age), blinded, placebo-controlled, parallel-group, superiority trial. 1. PPOIT Probiotic and peanut OIT taken daily for 18 months. 2. OIT Probiotic placebo and peanut OIT taken daily for 18 months. 3. 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.

Arms & Interventions

Arms

Active Comparator: Probiotic and Peanut Oral Immunotherapy (PPOIT)

Probiotic and peanut oral immunotherapy taken daily for 18 months

Active Comparator: Placebo Probiotic and Peanut Oral Immunotherapy

Placebo probiotic and peanut oral immunotherapy taken daily for 18 months

Placebo Comparator: Placebo Probiotic and Placebo Oral Immunotherapy

Placebo probiotic and placebo oral immunotherapy taken daily for 18 months

Interventions

Combination Product: - PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations

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

Combination Product: - PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations

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: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hong Kong, Hong Kong

Status

Recruiting

Address

Department of Paediatrics and Adolescent Medicine, Hong Kong Children's Hospital

Hong Kong, ,

Site Contact

Ting Fan Leung

tfleung@cuhk.edu.hk

852-35052859

Hong Kong, Hong Kong

Status

Recruiting

Address

Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital

Hong Kong, ,

Site Contact

Mike Yat Wah Kwan

kwanyw1@ha.org.hk

852-35052859

Hong Kong, Hong Kong

Status

Recruiting

Address

Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, ,

Site Contact

Agnes Leung

agnes.syl@cuhk.edu.hk

+85235052859

Hong Kong, Hong Kong

Status

Recruiting

Address

Department of Paediatrics, Queen Elizabeth Hospital

Hong Kong, ,

Site Contact

Wai Hung Chan

cwhz01@ha.org.hk

852-35052859

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