Authors: Gara Arteaga-Henríquez ,Carolina Ramos-Sayalero, Pol Ibanez-Jimenez ˜ , Silvia Karina Rosales-Ortiz , Tünde Kilencz , Carmen Schiweck, Isabel Schnorrf , Anne Siegl , Alejandro Arias-Vasquez, Istvan ‘ Bitter , Christian Fadeuilhe, Marc Ferrer, Catharina Lavebratt, Silke Matura , Andreas Reif , Janos’ M. R´ethelyi ,Vanesa Richarte, Nanda Rommelse, Josep Antoni Ramos-Quiroga.
Published: Brain, Behaviour and Immunity 120 (2024).
The study was conducted in vivo, involving human participants.
Design: A randomized, double blind, placebo-controlled study. Randomization was completed by a research assistant not otherwise involved in the study by the use of an independent randomization service (s. 361).
Treatment: Synbiotic 2000 or placebo. Participants were instructed to take it once daily during the 10 weeks of study.
Where and when: The study was conducted between February 2019 and October 2020 at three European clinical centers located in Hungary, Spain and Germany.
Sample size: 180 patients.
Sample criteria: Included were patients aged 18–65 years old diagnosed with ADHD and/or BPD and high levels of irritability. Excluded were patients with past and/or current psychotic symptoms, as well as those with any major neurological, cardiovascular, endocrine, pulmonary, immunological and/or gastrointestinal disorder at screening. Patients under anti-inflammatory and/or psychiatric medication were included only in case the type of agent and dosage taken were stable for at least 30 days prior to study entry. Patients undergoing immunosuppression or under antibiotics or probiotics within the last 30 days prior to study entry were also excluded. (s 361).
Analysed material: Blood samples, self-reported questionnaire.
The study finds itself to be the first randomized, placebo-controlled clinical trial with the primary research question being the superiority of a synbiotic over placebo in the management of adults diagnosed with two different (but symptomatic overlapped) psychiatric conditions (i.e., ADHD and/or BPD) and high levels of multidimensional irritability (s. 365).
Results
The synbiotic was well tolerated. At week 10, patients allocated to the synbiotic experienced a significantly higher response rate compared to those allocated to placebo.
After 10 weeks of continuous treatment, a statistically significantly higher proportion of patients in the synbiotic group achieved a clinically meaningful improvement in irritability, compared to placebo. A synbiotic-specific improvement in emotional dysregulation, emotional symptoms, inattention, several facets of functioning and perceived stress levels was also suggested.
Lower baseline levels of RANK-L were associated with end-of-treatment response in the synbiotic group, while higher baseline levels of IL-17A were associated with a significantly higher improvement in emotional dysregulation in the placebo group. (s. 369).
Indicative results
These findings suggest that treatment with a synbiotic may be associated with a clinically meaningful improvement in irritability in, at least, a subgroup of adults with ADHD and/or BPD. A superiority of the synbiotic over placebo in the management of emotional dysregulation, emotional symptoms, inattention, functioning and perceived stress levels.
The study says to (for the first time) show preliminary evidence suggesting (add-on) treatment with a synbiotic, as a reliable and safe therapeutic option in the management of adults diagnosed with ADHD and/or BPD and high levels of irritability.
Larger prospective studies are warranted to confirm the findings. (s. 351).
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