ADHD, Emotion Regulation Abilities, Gastrointestinal
Conditions
Keywords
emotion regulation, gastrointestinal health, probiotics, synbiotics, gut-brain axis, ADHD
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.
Interventions
DIETARY_SUPPLEMENTSynbiotic Cap Gut-Brain
Capsules (2 capsules to be ingested once daily during 12 weeks)
OTHERPlacebo
Capsules (2 capsules to be ingested once daily during 12 weeks)
Sponsors
Super Synbiotics AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the total score of Difficulties Regulation Scale 16 (DERS-16) after 12 weeks of intervention. | Change from baseline to 12 weeks | All subscales are included in the total score of DERS-16 (Clarity, Goals, Impulse, Strategies and Nonacceptance) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in total score for gastrointestinal symptoms (based on a questionnaire) after 12 weeks of intervention. | 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. |
| Change from baseline in total score of ASRS v1.1 after 12 weeks of intervention | 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. |
| Change from baseline in the DERS-16 subscale scores after 12 weeks of intervention. | 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 |
| Change from baseline in the frequency of individual gastrointestinal symptoms after 12 weeks of intervention. | Change from baseline to 12 weeks | The individual gastrointestinal symptoms include flatulence, bloating, loose/hard stools, gut pain, feeling sick. |
| Change from baseline in the score of individual ASRS v1.1 items after 12 weeks of intervention. | Change from baseline to 12 weeks. | The 18 ASRS items will be assessed separately. |
Contacts
CONTACTLudvig Ekelund
Outcome results
None listed