ADHDNCT07717359
ADHD, Gut Problems and Synbiotic
A study testing Synbiotic Cap Gut-Brain in people with ADHD and Gastrointestinal, run by Super Synbiotics AB.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- ADHD, Gastrointestinal, Emotion Regulation Abilities
- What is being tested?
- Synbiotic Cap Gut-Brain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Has consumed antibiotics within the previous 6 weeks
- Has a serious disease that requires treatment and/or leads to a weakened immune system
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Gut-Brain Study: ADHD, Gastrointestinal Problems and Synbiotic Cap
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
- Being tested
- Synbiotic Cap Gut-Brain, Placebo
- Keywords
- emotion regulation, gastrointestinal health, probiotics, synbiotics, gut-brain axis, ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic Cap Gut-BrainDietary supplement
Capsules (2 capsules to be ingested once daily during 12 weeks)
PlaceboOther
Capsules (2 capsules to be ingested once daily during 12 weeks)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Change from baseline to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startSep 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Super Synbiotics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717359
- Sponsor's protocol ID
- Gut-Brain Study
- Status last verified
- May 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut-Brain Study: ADHD, Gastrointestinal Problems and Synbiotic Cap
- ClinicalTrials.gov ID
- NCT07717359
- Acronym / sponsor ID
- Gut-Brain Study
- Conditions
- ADHD, Gastrointestinal, Emotion Regulation Abilities
- Keywords
- emotion regulation, gastrointestinal health, probiotics, synbiotics, gut-brain axis, ADHD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Super Synbiotics ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic Cap Gut-Brain | Experimental | Dietary Supplement: Synbiotic Cap Gut-BrainCapsules 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. |
| Placebo | Placebo comparator | Other: PlaceboCapsules 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Has consumed antibiotics within the previous 6 weeks
- Has a serious disease that requires treatment and/or leads to a weakened immune system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synbiotic Cap Gut-BrainCapsules (2 capsules to be ingested once daily during 12 weeks) | Dietary supplement | Synbiotic Cap Gut-Brain |
| PlaceboCapsules (2 capsules to be ingested once daily during 12 weeks) | Other | Placebo |
Primary outcome
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)
5 secondary outcomes
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
Change from baseline in total score of ASRS v1.1 after 12 weeks of intervention
Time frame: Change from baseline to 12 weeks
Change from baseline in the DERS-16 subscale scores after 12 weeks of intervention.
Time frame: Change from baseline after 12 weeks.
Change from baseline in the frequency of individual gastrointestinal symptoms after 12 weeks of intervention.
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.
Time frame: Change from baseline to 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic Cap Gut-Brain in people with ADHD and Gastrointestinal, run by Super Synbiotics AB.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ludvig Ekelund (+46 8 6601660, forskning@supersynbiotics.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.