ADHD, Gut Problems and Synbiotic

NCT07717359 | Not Yet Recruiting

• 1 other identifier: Gut-Brain Study
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ADHD; Gastrointestinal; Emotion Regulation Abilities

Keywords

emotion regulation; gastrointestinal health; probiotics; synbiotics; gut-brain axis; ADHD

Outcome Measures

Primary Outcomes (1)

• 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)

  Change from baseline to 12 weeks

Secondary Outcomes (5)

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

  Change from baseline to 12 weeks

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

  Change from baseline to 12 weeks

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

  Change from baseline after 12 weeks.

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

  Change from baseline to 12 weeks

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

  Change from baseline to 12 weeks.

Study Arms (2)

Synbiotic Cap Gut-Brain

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Synbiotic Cap Gut-Brain DIETARY_SUPPLEMENT

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

Synbiotic Cap Gut-Brain

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Super Synbiotics AB: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Emotional Regulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Central Study Contacts

Ludvig Ekelund

CONTACT

+46 8 6601660; forskning@supersynbiotics.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share