ADHD, Gut Problems and Synbiotic
- Sponsor
- Super Synbiotics AB
- Study ID
- NCT07717359
- Status
- Not Yet Recruiting
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Conditions
- ADHD
- Emotion Regulation Abilities
- Gastrointestinal
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 64 Years
- Healthy Volunteers
- Not accepted
Interventions
- Synbiotic Cap Gut-Brain — DIETARY_SUPPLEMENTCapsules (2 capsules to be ingested once daily during 12 weeks)
- Placebo — OTHERCapsules (2 capsules to be ingested once daily during 12 weeks)
Study Details
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.
Key Dates
- First listed
- Jul 21, 2026
- Start date
- Sep 30, 2026
- Status verified
- May 2026
- Primary completion
- Oct 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 174 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: 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 Comparator: 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.
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 ]
Central Contacts
- Ludvig Ekelund+46 8 6601660
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