Clinical trial NCT05155696: Probiotic Supplementation in Children With ADHD
Official title: A Randomised Controlled Trial of the Effects of a Probiotic Drink on Behaviour, Sleep and the Microbiome in Children With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: microbiome
ADHD
probiotic
Kefir
Lead sponsor: St. Mary's University, Twickenham
Sponsor class: OTHER
Collaborators: name: Goldsmiths, University of London
name: London South Bank University
First posted: 2021-12-13
Enrollment: 81
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised double-blind quantitative repeated measures design
Primary purpose: TREATMENT

Brief summary: This randomised, placebo controlled trial explores the effects of supplementation with a probiotic drink (kefir) in children diagnosed with ADHD on behaviour, sleep, attention and the gut microbiome.

Detailed description: Children with Attention Deficit Hyperactivity Disorder (ADHD) can suffer debilitating symptoms, including problematic behaviour and sleep. Dietary manipulations may be a helpful treatment option for children, but the most effective are highly restrictive, with little known about why they might work.

Optimising gut bacteria may help alleviate some of the symptoms of this condition via the gut-brain-axis. The consumption of a probiotic fermented drink (kefir) can positively influence composition of gut bacteria.

The purpose of this study is to explore the effects of supplementation of a probiotic drink (kefir) on behaviour, sleep, attention and the gut microbiome in children diagnosed with ADHD.

In a six-week randomised controlled double-blind, placebo controlled trial, 70 children diagnosed with ADHD (aged 8-13 years) will be randomised to be given either a probiotic drink (kefir) or a placebo drink. At the beginning and the end of the study a combination of questionnaires, cognitive assessment, sleep/physical activity measures and microbiome analysis will be employed to assess the effect of kefir consumption on symptoms of ADHD and the gut microbiome.

Eligibility criteria: Inclusion Criteria:

* A previous diagnosis of ADHD according to the DSM-IV or DSM-V criteria by a qualified health care professional.
* Children aged between 8 and 13 years at the time of study.
* Children with a comorbidity will be accepted.
* Both males and females

Exclusion Criteria:

* Children currently undergoing a current course of behavioural therapy.
* Children with a reported milk allergy or lactose intolerance.
* Reported use of antibiotics, probiotics, antifungals or steroids in the past four weeks.
* Diagnosis of a gastrointestinal disorder e.g., Inflammatory Bowel Disease or Coeliac disease.
* Diagnosis of an auto-immune disease or compromised immunity.

Primary outcomes:
measure: Change in The Strengths and Weakness of ADHD-symptoms and Normal-behaviour (SWAN) scale
timeFrame: week 0 and week 6
Secondary outcomes:
measure: Change in The Go/NoGo test
timeFrame: week 0 and week 6
measure: Change in mean activity during sleep.
timeFrame: week 0 and week 6
measure: Change in minutes spent awake during the down period
timeFrame: week 0 and week 6
measure: Change in sleep latency
timeFrame: week 0 and week 6
measure: Change in sleep efficiency
timeFrame: week 0 and week 6
measure: Change in wake after sleep onset
timeFrame: week 0 and week 6
measure: Change in sleep fragmentation
timeFrame: week 0 and week 6
measure: Change in mean daytime activity
timeFrame: week 0 and week 6
measure: The Consensus Sleep diary
timeFrame: week 0 and week 6
measure: The Consensus Sleep diary
timeFrame: week 6
measure: Change in The Child's Sleep habits questionnaire
timeFrame: week 0 and week 6
measure: Change in Sleep self report
timeFrame: week 0 and week 6
measure: Change in The Gastrointestinal Severity Index
timeFrame: week 0 and week 6
measure: Change in stool microbiome analysis
timeFrame: week 0 and week 6
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's University
state: Greater London
Study officials:
affiliation: St. Mary's University, Twickenham
name: Kate Lawrence, PhD
role: PRINCIPAL_INVESTIGATOR
References: