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

NCT05165329 | Active Not Recruiting DMC

• 1 other identifier: PPOIT-HK
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Peanut Allergy; Food Allergy in Children

Keywords

peanut allergy; oral immunotherapy; sustained unresponsiveness; tolerance

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in PPOIT vs placebo

  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.

  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.

  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.

  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.

  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.

  TEAEs will be collected until T2 - 8 weeks after final day of maintenance.

Study Arms (3)

Probiotic and Peanut Oral Immunotherapy (PPOIT)

ACTIVE COMPARATOR

Probiotic and peanut oral immunotherapy taken daily for 18 months

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

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

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.

Interventions

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

Probiotic and Peanut Oral Immunotherapy (PPOIT)

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.

Placebo Probiotic and Placebo Oral Immunotherapy

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (4)

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

Hong Kong, Hong Kong

Location

Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital

Hong Kong, Hong Kong

Location

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

Hong Kong, Hong Kong

Location

Department of Paediatrics, Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

Related Links

• Related Info

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

Food Coloring Agents; Taste

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Coloring Agents; Specialty Uses of Chemicals; Chemical Actions and Uses; Food Additives; Food Ingredients; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ting Fan Leung

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Ting-fan Leung

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 21, 2021
• Study Start: November 11, 2021
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (4)