Health Trials

A Clinical Trial Evaluating Fecal Microbiota Transplantation (FMT) in Adolescents With ADHD

ConditionsADHDADHD - Attention Deficit Disorder With HyperactivityADHD - Combined Type
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age13-18
SponsorUniversity of Calgary

About this trial

The primary goals of this phase 2 clinical trial are to determine the feasibility, safety, and tolerability of oral Fecal Microbiota Transplantation (FMT) in adolescents (aged 13-17) with Attention-Deficit/Hyperactivity Disorder (ADHD).

Eligibility criteria

Qualifiers

Between 13-17 years of age with consent of a legal guardian: Participants should be at least 13 years old and not older than 17 years at the day of screening (V1).

Have a primary diagnosis of ADHD as confirmed by the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).

Be on a stable appropriate dose of an appropriate first-line pharmacological treatment for at least 8 weeks prior to the day of screening (V1).

Have a score of ≥ 18 on the inattention subset (questions 1-9) and/or the hyperactivity/impulsivity subset (questions 10-18) of the SNAP-IV 26-Item Parent Rating Scale on the day of screening (V1) and the baseline visit (V2).

Disqualifiers

Diagnosis of a Substance Use Disorder within the last 3 months prior to screening. *(Criteria should include Alcohol and Non-Alcohol substances except Cannabis)

Moderate or severe Substance Use Disorder for Cannabis use in the last 3 months

Currently active high suicidality. Eligibility of Participants who meet criteria for moderate suicidality is determined by clinical judgment of Principal Investigator.

Active Anorexia Nervosa or Bulimia Nervosa in the last 3 months.

Trial design

Treatments tested in this trial

  • Fecal Microbiota Transplant (FMT)
  • Nitazoxanide 500mg BID
  • Vancomycin 250mg BID
  • Placebo Vancomycin
  • Placebo Nitazoxanide
  • Pico-Salax
  • Placebo Fecal Microbiota Transplantation (FMT)

Treatment groups

64 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Calgary

Lead sponsor

Hotchkiss Brain Institute, University of Calgary

Collaborator

Alberta Children's Hospital

Collaborator

Source ClinicalTrials.gov