Clinical Trial Details

A multicentre, randomized, controlled trial of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with placebo.

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Trial Information

Broad Health Condition Inflammatory and Immune System

Specific Health ConditionAllergies

Trial FocusTreatment

Recruitment statusCompleted

Recruitment Details
Recruitment State
SA,WA,VIC

Hospital
The Royal Childrens Hospital - Parkville
Womens and Childrens Hospital - North Adelaide
Princess Margaret Hospital - Subiaco


Postcode
3052 - Parkville
6008 - Subiaco
5006 - North Adelaide

Anticipated date of first participant enrolment2/05/2016

Anticipated date of last participant enrolment2/05/2016

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

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. Research shows that 50% of children with a peanut allergy are accidentally exposed to peanut within 2 years. 

Researchers have begun to look at the effectiveness of 'oral immunotherapy' as a treatment for food allergy. In oral immunotherapy, patients with food allergy are given small amounts of the food they are allergic to and tested for food allergy after a set amount of time. Results have been mixed. Studies suggest that oral immunotherapy can induce desensitization (short term ability to tolerate the food allergen while the patient continues on therapy) but has a limited ability to induce sustained unresponsiveness (longer term ability to tolerate the food allergen after treatment is stopped for at least 2-4 weeks or longer). We previously conducted a Randomized Controlled Trial to evaluate a novel combination treatment approach involving administration of probiotic together with oral immunotherapy - Probiotic and Peanut Oral Immunotherapy (PPOIT). In our study we found that just over 80% of children who received PPOIT tolerated peanut after stopping treatment for more than 2 weeks compared with only 4% in the placebo group. PPOIT was highly effective at inducing sustained unresponsiveness - if 9 children were treated with PPOIT, 7 would benefit. 

PPOIT participants received a daily dose of probiotic together with peanut protein (peanut flour) for 18 months. The probiotic was taken as a fixed daily dose. The dose of peanut protein was commenced at very low levels then increased every 2 weeks over a period of 8 months to reach a maintenance dose of 2g peanut protein.

This study (PPOIT-III) will build on our previous PPOIT and PPOIT-II study. PPOIT-III is a multi- site randomized controlled trial to evaluate the effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing desensitisation or 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. 

The discovery of a safe and tolerable treatment for food allergy will have great public health benefit.
Eligibility

Key inclusion criteria

Children are eligible for the study if they meet all of these criteria:
- Children aged between 1 year and 10 years of age
- greater than 7kg (the weight considered safe for the administration of an Epipen/EpiPen Jr)
- Confirmed diagnosis of peanut allergy as defined by a failed Double-Blind, Placebo-Controlled Food Challenge (CBPCFC) with peanut and a positive SPT or SIgE to peanut at screening.

Minimum age1 Years

Maximum age10 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Children are not eligible for the study if they meet any of these criteria:
- History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three 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 three or more doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
- FEV1 less than 85% at rest and FEV1/FVC is less than or equal to 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 associated with anaphylaxis
- Use of beta-blockers, and ACE inhibitors
- Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immune-compromised states, post-cardiac and/or gastrointestinal tract surgery, critically-ill and those requiring prolonged hospitalisation or other conditions that may increase the risks of probiotic associated sepsis
- Already taking probiotic supplements within the past 6 months (does not include formula)
- Reacting to the placebo component during the study entry DBPCFC
- Have received other food immunotherapy treatment in the preceding 12 months
- 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)
Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Murdoch Childrens Research Institute
Primary Sponsor Address: The Royal Children's Hospital, Flemington Road, Parkville, Victoria 3052
Primary Sponsor Country: Australia

Trial IDACTRN12616000322437

Contact person for information and recruitmentMs
Christine Axelrad
Allergy and Immune Disorders Murdoch Childrens Research Institute Flemington Rd Parkville Victoria 3052
+61 3 9345 6974

Further information iconChristine.Axelrad@rch.org.au
Australia