An interventional study of Synbiotic Cap Gut-Brain and Placebo in ADHD, Gastrointestinal and Emotion Regulation Abilities, sponsored by Super Synbiotics AB. Not yet recruiting. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Super Synbiotics AB · Not applicable, Interventional, and Supportive care
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.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's planned enrollment of 174 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →This is the only study on the registry with Super Synbiotics AB as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Capsules containing the synbiotic product being evaluated. The product consists of a combination of probiotic bacteria (at a total dose of 15 x 10\^9 CFU/2 capsule), dietary fibers (120 mg), calcium and vitamin B. The participants will be instructed to consume 2 capsules once every day, during a period of 12 weeks.
Dietary Supplement: Synbiotic Cap Gut-Brain
Capsules containing placebo consisting of maltodextrin. The capsules look, smell and taste the same as the capsules for the experimental product. The participants will be instructed to consume 2 capsules once every day, during a period of 12 weeks.
Other: Placebo
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.
Time frame: Change from baseline to 12 weeks.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→