A Pilot Randomized Controlled Trial to Explore Cognitive and Emotional Effects of Probiotics in Fibromyalgia.

It has recently been found that microbes in the gut may regulate brain processes through the gut microbiota-brain axis, which modulates affection, motivation and higher cognitive functions. According to this finding, the use of probiotics may be a potential treatment to improve physical, psychological and cognitive status in clinical populations with altered microbiota balance such as those with fibromyalgia (FMS). Thus, the aim of the present pilot study with a double-blind, placebo-controlled, randomised design was to test whether a multispecies probiotic may improve cognition, emotional symptoms and functional state in a sample of patients diagnosed with FMS. Pain, impact of FMS, quality of life, anxiety and depressive symptoms were measured during the pre- and post-intervention phases; participants also completed two computerised cognitive tasks to assess impulsive choice and decision-making. Finally, urinary cortisol concentration was determined. To our knowledge, this is the first study that explore the effect of a multispecies probiotic in FMS patients. Our results indicated that probiotics improved impulsivity and decision-making in these patients. However, more research is needed to further explore the potential effects of probiotics on other cognitive functions affected in FMS as well as in other clinical populations.

Probiotics for fibromyalgia: study design for a pilot double-blind, randomized controlled trial.

BACKGROUND: Fibromyalgia syndrome (FMS) is a chronic, generalized and diffuse pain disorder accompanied by other symptoms such as emotional and cognitive deficits. The FMS patients show a high prevalence of gastrointestinal symptoms. Recently it has been found that microbes in the gut may regulate brain processes through the gut-microbiota-brain axis, modulating thus affection, motivation and higher cognitive functions. Therefore, the use of probiotics might be a new treatment that could improve the physical, psychological and cognitive state in FMS; however, no evidence about this issue is available. METHODS: This paper describes the design and protocol of a double-blind, placebo-controlled and randomized pilot study. We use validated questionnaires, cognitive task through E-Prime and biological measures like urine cortisol and stool fecal samples. The trial aim is to explore the effects of eight weeks of probiotics therapy in physical (pain, impact of the FMS and quality of life), emotional (depression, and anxiety) and cognitive symptoms (attention, memory, and impulsivity) in FMS patients as compared to placebo. CONCLUSION: This pilot study is the first, to our knowledge, to evaluate the effects of probiotics in FMS. The primary hypothesis was that FMS patients will show a better performance on cognitive tasks, and an improvement in emotional and physical symptoms. These results will contribute to a better understanding in the gut-brain axis. Here we present the design and protocol of the study.

Probiotics for fibromyalgia: study design for a pilot double-blind, randomized controlled trial / Probióticos en fibromialgia: diseño de un estudio piloto doble ciego y randomizado

Background: Fibromyalgia syndrome (FMS) is a chronic, generalized and diffuse pain disorder accompanied by other symptoms such as emotional and cognitive deficits. The FMS patients show a high prevalence of gastrointestinal symptoms. Recently it has been found that microbes in the gut may regulate brain processes through the gut-microbiota-brain axis, modulating thus affection, motivation and higher cognitive functions. Therefore, the use of probiotics might be a new treatment that could improve the physical, psychological and cognitive state in FMS; however, no evidence about this issue is available. Methods: This paper describes the design and protocol of a double-blind, placebo-controlled and randomized pilot study. We use validated questionnaires, cognitive task through E-Prime and biological measures like urine cortisol and stool fecal samples. The trial aim is to explore the effects of eight weeks of probiotics therapy in physical (pain, impact of the FMS and quality of life), emotional (depression, and anxiety) and cognitive symptoms (attention, memory, and impulsivity) in FMS patients as compared to placebo. Conclusion: This pilot study is the first, to our knowledge, to evaluate the effects of probiotics in FMS. The primary hypothesis was that FMS patients will show a better performance on cognitive tasks, and an improvement in emotional and physical symptoms. These results will contribute to a better understanding in the gut-brain axis. Here we present the design and protocol of the study (AU)

Antecedentes: el síndrome de fibromialgia (FMS) es un trastorno crónico, generalizado y difuso que produce dolor acompañado de otros síntomas emocionales y cognitivos. Así mismo, los pacientes con FMS muestran una alta comorbilidad de síntomas gastrointestinales. En este sentido, recientemente se ha encontrado que la microbiota intestinal es capaz de regular procesos cerebrales a través del eje intestino-microbiota-cerebro, modulando así a nivel afectivo, emocional, motivacional y de funciones cognitivas complejas. Por lo tanto, el uso de probióticos podría ser una nueva estrategia terapéutica para mejorar el estado físico, psicológico y cognitivo en pacientes con FMS. Sin embargo, aún no hay evidencia disponible sobre este tema. Métodos: este artículo describe el diseño y el protocolo de un estudio piloto doble ciego, controlado con placebo y aleatorizado. Se utilizan cuestionarios validados, tareas cognitivas a través de E-Prime y medidas biológicas como cortisol de orina y muestras de heces. El objetivo del estudio es explorar el efecto de un tratamiento multiespecies probióticas durante ocho semanas en la sintomatología física (dolor, impacto del FMS y calidad de vida), emocional (depresión y ansiedad) y cognitiva (atención, memoria e impulsividad) en pacientes con FMS. Conclusión: el protocolo de este estudio piloto, a nuestro conocer, es el primero que pretende evaluar los efectos de los probióticos en FMS. La hipótesis de partida es que los pacientes con FMS mostrarán un mejor desempeño en las tareas cognitivas y una mejoría en los síntomas emocionales y físicos. Estos resultados contribuirán a una mejor comprensión del eje intestino-cerebral (AU)