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NCT Number: NCT07717359

ADHD, Gut Problems and Synbiotic

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Emotion Regulation Abilities Emotional Regulation Gastrointestinal Mental Disorders Neurodevelopmental Disorders Self-Control Social Behavior

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ADHD-diagnosis
  • Self-described gastrointestinal problems
  • Has not previously consumed Synbiotics
  • Be prepared to avoid supplements with lactic acid bacteria, calcium and vitamin B6, B9, and B12, starting from washout

Exclusion criteria

  • Has consumed antibiotics within the previous 6 weeks
  • Has a serious disease that requires treatment and/or leads to a weakened immune system

Treatment and study plan

Synbiotic Cap Gut-Brain

Dietary Supplement

Capsules (2 capsules to be ingested once daily during 12 weeks)

Placebo

Other

Capsules (2 capsules to be ingested once daily during 12 weeks)

Primary outcomes

  1. Change from baseline in the total score of Difficulties Regulation Scale 16 (DERS-16) after 12 weeks of intervention.

    Time frame: Change from baseline to 12 weeks

    All subscales are included in the total score of DERS-16 (Clarity, Goals, Impulse, Strategies and Nonacceptance)

Secondary outcomes

  1. Change from baseline in total score for gastrointestinal symptoms (based on a questionnaire) after 12 weeks of intervention.

    Time frame: Change from baseline to 12 weeks

    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.

  2. Change from baseline in total score of ASRS v1.1 after 12 weeks of intervention

    Time frame: Change from baseline to 12 weeks

    The adult ADHD self-report scale consists of 18 items. Change from baseline in the total score for these items will be measured.

  3. Change from baseline in the DERS-16 subscale scores after 12 weeks of intervention.

    Time frame: Change from baseline after 12 weeks.

    The score for each of the DERS-16 subscales (Clarity, Goals, Impulse, Strategies and Nonacceptance) will be analyzed separately

  4. Change from baseline in the frequency of individual gastrointestinal symptoms after 12 weeks of intervention.

    Time frame: Change from baseline to 12 weeks

    The individual gastrointestinal symptoms include flatulence, bloating, loose/hard stools, gut pain, feeling sick.

  5. Change from baseline in the score of individual ASRS v1.1 items after 12 weeks of intervention.

    Time frame: Change from baseline to 12 weeks.

    The 18 ASRS items will be assessed separately.

Study contacts

Contact information is provided by the study sponsor or research team.

Ludvig Ekelund

CONTACT

[email protected]

+46 8 6601660

Sponsors and collaborators

Lead sponsor

Super Synbiotics AB

Industry

Registry information

Official study title

Gut-Brain Study: ADHD, Gastrointestinal Problems and Synbiotic Cap

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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