ADHD, Gut Problems and Synbiotic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorSuper Synbiotics AB
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Has consumed antibiotics within the previous 6 weeks
Has a serious disease that requires treatment and/or leads to a weakened immune system
Trial design
Design model
Parallel
Treatments tested in this trial
Synbiotic Cap Gut-Brain
Dietary supplementCapsules (2 capsules to be ingested once daily during 12 weeks)
Placebo
Other interventionCapsules (2 capsules to be ingested once daily during 12 weeks)
Treatment groups
174 Participants
are divided into 2 treatment groupsGroup A: Synbiotic Cap Gut-BrainExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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)
Time frame
Change from baseline to 12 weeksSecondary outcomes
1
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.
Time frame
Change from baseline to 12 weeks2
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.
Time frame
Change from baseline to 12 weeks3
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
Time frame
Change from baseline after 12 weeks.4
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.
Time frame
Change from baseline to 12 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: