None listed
Conditions
Brief summary
We plan to undertake a feasibility study in children who have IgE-mediated allergy to foods previously proven by food challenge. The study aims to demonstrate improved tolerance to food by retesting reactions to food after receiving 3 months of daily probiotic supplementation with L.rhamnosus HN001. We hypothesize that HN001 will improve the children’s tolerance to foods by moderating their immune response, as demonstrated in other studies. The results of this pilot study will inform the design of a larger fully-powered randomized control trial (RCT) to examine the efficacy and mechanism of action of this probiotic in improving food tolerance in food allergy. We will collect stools from children before/after the food challenge to see if either of two markers of bowel inflammation may assist in diagnosing IgE-mediated food allergy
Interventions
A pilot double-blind randomised placebo-controlled trial of the capacity of an established probiotic, Lactobacillus rhamnosus HN001, to enhance food tolerance in children diagnosed with IgE-mediated food allergy who have been referred by their paediatrician at Capital and Coast District Health Board (CCDHB) to undergo an open oral food challenge.
Children will receive a capsule (either whole or contents sprinkled on food) containing HN001 at a dose of 9.2 x 10^9 CFU daily (or placebo) for three
A pilot double-blind randomised placebo-controlled trial of the capacity of an established probiotic, Lactobacillus rhamnosus HN001, to enhance food tolerance in children diagnosed with IgE-mediated food allergy who have been referred by their paediatrician at Capital and Coast District Health Board (CCDHB) to undergo an open oral food challenge. Children will receive a capsule (either whole or contents sprinkled on food) containing HN001 at a dose of 9.2 x 10^9 CFU daily (or placebo) for three months, started immediately after the food challenge. Participants will be instructed to keep the capsule bottle (even if empty) containing unused capsules for return to study staff. At the repeat food challenge appointment, the study nurse will collect the capsule bottle with the remaining capsules, if any, from the participant and store these in the walk-in fridge at Wellington Asthma Research Group,. As a check on compliance, these will be counted and numbers recorded in the ProFood Study database. This will be done only at the end of the study as it is important that all researchers involved in seeing participants remain blind. If a participant loses a capsule bottle, research staff should ask for an estimate of how many capsules had been taken when it was lost. When entering this into the ProFood Study database, we will estimate the number remaining by subtracting the estimated number taken from 105 and ticking the box to show it was an estimate. If a participant forgets to bring the remaining capsules to the end of study visit, the research staff will give them a pre-paid, self-addressed envelope to post the capsule bottle back to School of Medicine. Children will be randomised to active or placebo groups as described. Those randomised to control will provide useful information as to the reliability of food challenges when repeated after approx 3 months, and also information on the natural time course of rising levels of calprotectin and/or faecal esterase [if seen] after a food challenge and comparisons between these two markers of gut inflammation. Those not eligible to take part in the study (either nearly fully tolerant of the food or so sensitive we would not consider re-challenge) can still elect to collect their infant's stools to provide further information on the natural history of faecal calprotectin and leucocyte esterase after a markedly positive or negative food challenge. Faecal collection times would be as per those children enrolled.
Sponsors
Thorsten V Stanley
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
children who are aged less than 16 years and have IgE-mediated food allergy with evidence of allergic sensitisation; and have failed steps 2, 3, or 4 (out of 5) of the first food challenge.
Exclusion criteria
children who: • will not be living in Wellington over the next 4 months • are currently using or intend to use probiotic drinks or supplements • are participating in another health-related research study involving an intervention • have a severe disorder such as kidney failure, cystic fibrosis, severe heart disease, or inflammatory bowel disease: • are on long-term or continuous antibiotic therapy • have cardiac valve disease where antibiotic prophylaxis is required • have a serious immunological disorder that suppresses immune function • are taking immunosuppressant drugs.
Outcome results
None listed