Psychobiotic RCTs: Bened to trial PS128 on Tourette and Rett syndrome patients following new findings on Parkinson’s

By Tingmin Koe contact

- Last updated on GMT

Bened is exploring the use of its flagship psychoprobiotics in improving Tourette and Rett syndrome. ©Getty Images
Bened is exploring the use of its flagship psychoprobiotics in improving Tourette and Rett syndrome. ©Getty Images

Related tags: Taiwan, psychobiotics, Probiotics

Bened Biomedical is making inroads into the study of psychobiotics as it embarks on a human clinical trial that looks at its flagship strain Lactobacillus plantarum PS128 on Tourette syndrome and Rett syndrome.

The company’s proprietary strain Lactobacillus plantarum ​PS128 has been shown to manage autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD)​ by regulating the dopamine level​ in specific brain regions.

Taking place in National Taiwan University Children Hospital, the study will involve 500 subjects with either Tourette syndrome or Rett syndrome.

They will be randomised to take either a tablet containing 300mg of PS128 or placebo twice per day.

Subjects with Tourette syndrome will undergo the trial for two months, while those with Rett syndrome will take the trial for four months.

Both Tourette syndrome and Rett syndrome are conditions that commonly manifest as uncontrollable, repetitive movements.

Existing literature as well as its preliminary reports have shown that the two conditions are linked to gut dysbiosis, the company said.

The patients’ neuropsychological and gut microbiota will be evaluated before and after the studies. The study is expected to complete by August this year.

New findings on Parkinson’s

This research also follows the company’s recent findings on how PS128 could benefit Parkinson’s symptoms.

Supplementation of the psychobiotic capsule nightly for three months was shown to reduce the level of myeloperoxidase (MPO) – a neuroinflammatory molecule.

The pilot study involving 25 Parkinson’s Disease (PD) patients, also showed that the psychobiotic had improved their overall Unified Parkinson Disease Rating Scale scores by 11.3 per cent during their “on-state” and 14.3 per cent during “off-state”.

“On-state” refers to moments when a PD patient’s symptoms are able to control their motor movements and vice versa.

"This study shows PS128's potential for alleviating on- and off-state symptoms [in PD patients].

"As a natural ingredient, PS128 also can be used without the worry of additional side effects that often come from Parkinson's drugs,” ​said Dr Alain Delpy, head of International Development at Bened.

Expanding on the pilot study, the strain is now trial on a larger subject population involving 120 participants for 12 weeks.

Other studies on how supplementing PS128 may reduce the duration of “off-state” in PD patients and its effects in preventing early onset of PD are also underway.

Insomnia

Another area that the company has been studying, is the effects of PS128 supplementation on self-reported insomnia.

The trial involved 40 subjects randomly assigned to the intervention and placebo groups taking two capsules with or without PS128 after dinner for 30 days.

Measures on their depressive symptoms, anxiety and sleep questionnaires were taken at baseline, during the middle and end of the study.

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