Probiotic Supplementation in Children With ADHD

NCT05155696 | Completed

• 1 other identifier: SMU_ETHICS_2020-21_240
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

microbiome; ADHD; probiotic; Kefir

Outcome Measures

Primary Outcomes (1)

• Change in The Strengths and Weakness of ADHD-symptoms and Normal-behaviour (SWAN) scale

  18 item scale comparing the child to other children of the same age. Each item is responded to on a seven-point scale ranging from far below average (-3) to far above average (+3). The scores are summed and divided by the number of items, to express the summary score as the average rating-per-item (range -3 to +3, with lower scores indicating more severe ADHD symptoms).

  week 0 and week 6

Secondary Outcomes (14)

• Change in The Go/NoGo test

  week 0 and week 6

• Change in mean activity during sleep.

  week 0 and week 6

• Change in minutes spent awake during the down period

  week 0 and week 6

• Change in sleep latency

  week 0 and week 6

• Change in sleep efficiency

  week 0 and week 6

Study Arms (2)

Kefir probiotic drink

EXPERIMENTAL

Daily kefir for 6 weeks.

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

placebo comparator

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo comparator

Interventions

Experimental: Kefir probiotic drink (supplied by Nourish) DIETARY_SUPPLEMENT

125ml per day of dairy based probiotic drink (Kefir) containing ≥ 50billion colony forming units (CFU), supplied in plain packaging.

Kefir probiotic drink

Placebo comparator DIETARY_SUPPLEMENT

125ml of non-fermented dairy based placebo (UHT milk) per day, supplied in plain packaging.

placebo comparator

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Mary's University, Twickenham: lead
• Goldsmiths, University of London: collaborator
• London South Bank University: collaborator

Study Sites (1)

St Mary's University

London, Greater London, TW1 4SX, United Kingdom

Location

Related Publications (2)

• Lawrence K, Fibert P, Toribio-Mateas M, Gregory AM, Hobbs J, Quadt F, Wright S, Cotter PD, Patel S, Myrissa K. Effects of kefir on symptoms, sleep, and gut microbiota in children with ADHD: a randomised controlled trial. BMC Psychiatry. 2025 Nov 24;25(1):1117. doi: 10.1186/s12888-025-07568-8.

  PMID: 41286799 DERIVED

• Lawrence K, Fibert P, Hobbs J, Myrissa K, Toribio-Mateas MA, Quadt F, Cotter PD, Gregory AM. Randomised controlled trial of the effects of kefir on behaviour, sleep and the microbiome in children with ADHD: a study protocol. BMJ Open. 2023 Dec 7;13(12):e071063. doi: 10.1136/bmjopen-2022-071063.

  PMID: 38149413 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kate Lawrence, PhD

  St. Mary's University, Twickenham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: a randomly generated 6-digit participant code will be allocated to each participant as a unique identifier for all data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Psychology

Model Details: Randomised double-blind quantitative repeated measures design

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 13, 2021
• Study Start: January 6, 2022
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol and Statistical analysis plan available as soon as protocol is published - no end date to availability.
• Access Criteria: Open Access

Locations

GB (1)