Probiotic Supplementation in Children With ADHD

St. Mary's University, Twickenham

Status: Completed

Conditions: ADHD

Treatments: Dietary Supplement: Experimental: Kefir probiotic drink (supplied by Nourish); Dietary Supplement: Placebo comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT05155696

SMU_ETHICS_2020-21_240

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 8 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 2 patient groups, including a placebo group

Kefir probiotic drink

Experimental group

Description:

Daily kefir for 6 weeks.

Treatment:

Dietary Supplement: Experimental: Kefir probiotic drink (supplied by Nourish)

placebo comparator

Placebo Comparator group

Description:

Daily non-fermented dairy based equivalent drink for 6 weeks.

Treatment:

Dietary Supplement: Placebo comparator