The scope of this study is to evaluate the impact of a synbiotic product (a combination of probiotic bacteria and prebiotics) on symptoms reported by participants with ADHD. The main focus is to study the efficacy of the synbiotic product as compared to a placebo in improving emotion regulation and gut-health associated symptoms in adults with ADHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
174
Capsules (2 capsules to be ingested once daily during 12 weeks)
Capsules (2 capsules to be ingested once daily during 12 weeks)
Change from baseline in the total score of Difficulties Regulation Scale 16 (DERS-16) after 12 weeks of intervention.
All subscales are included in the total score of DERS-16 (Clarity, Goals, Impulse, Strategies and Nonacceptance)
Time frame: Change from baseline to 12 weeks
Change from baseline in total score for gastrointestinal symptoms (based on a questionnaire) after 12 weeks of intervention.
The questionnaire consists of a 5-point scale to evaluate the frequency of symptoms such as flatulence, bloating, loose/hard stools, gut pain, feeling sick.
Time frame: Change from baseline to 12 weeks
Change from baseline in total score of ASRS v1.1 after 12 weeks of intervention
The adult ADHD self-report scale consists of 18 items. Change from baseline in the total score for these items will be measured.
Time frame: Change from baseline to 12 weeks
Change from baseline in the DERS-16 subscale scores after 12 weeks of intervention.
The score for each of the DERS-16 subscales (Clarity, Goals, Impulse, Strategies and Nonacceptance) will be analyzed separately
Time frame: Change from baseline after 12 weeks.
Change from baseline in the frequency of individual gastrointestinal symptoms after 12 weeks of intervention.
The individual gastrointestinal symptoms include flatulence, bloating, loose/hard stools, gut pain, feeling sick.
Time frame: Change from baseline to 12 weeks
Change from baseline in the score of individual ASRS v1.1 items after 12 weeks of intervention.
The 18 ASRS items will be assessed separately.
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Time frame: Change from baseline to 12 weeks.