ADHD, Gut Problems and Synbiotic
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Synbiotic Cap Gut-Brain, Placebo.
- Who it may be relevant to
- Registry conditions: ADHD, Gastrointestinal, Emotion Regulation Abilities. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Gut-Brain Study: ADHD, Gastrointestinal Problems and Synbiotic Cap
Overview
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.
Interventions
- Dietary supplement Synbiotic Cap Gut-Brain
Capsules (2 capsules to be ingested once daily during 12 weeks) - Other Placebo
Capsules (2 capsules to be ingested once daily during 12 weeks)
Primary outcome measures
- 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]
Secondary outcome measures (5)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07717359 · Gut-Brain Study