Probiotics for Fibromyalgia: Study design for a pilot double-blind, randomized controlled trial.

Abstract

ResumenAntecedentes: 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. AbstractBackground: 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 ...

Dietary Interventions in the Management of Fibromyalgia: A Systematic Review and Best-Evidence Synthesis

“…Participant characteristics were recorded in Table 2 . Seven studies investigated populations living in the United States of America [ 29 , 30 , 31 , 32 , 33 , 34 , 35 ]; five from Spain [ 36 , 37 , 38 , 39 , 40 ], two from Italy [ 41 , 42 ], and one from each of Portugal [ 43 ], Pakistan [ 44 ], Finland [ 45 ], Austria [ 46 ], France [ 47 ], Brazil [ 48 ], Turkey [ 49 ] and the United Kingdom [ 50 ].…”

“…Across the 22 studies, there were 17 different dietary interventions ( Table 3 ): coenzyme Q10 [ 38 , 39 , 41 ], vitamin D [ 33 , 46 ]; probiotics [ 40 ]; Chlorella green algae [ 35 ]; vegan diet [ 45 ]; tart cherry juice [ 30 ]; low-FODMAP diet [ 43 ]; soy [ 34 ]; extra-virgin olive oil [ 37 ]; caffeine [ 32 ]; elimination of MSG [ 31 ]; elimination of MSG and aspartame [ 36 ]; vitamin C, E & nigella sativa seeds [ 44 ], vitamins C and E [ 49 ], creatine [ 48 ] and acetyl- l -carnitine [ 42 ]. Finally, two studies investigated phytotherapy-based supplements which included a myriad of different plant extracts [ 47 , 50 ] and one study investigated a phytotherapy-based supplement alongside an elimination diet [ 29 ].…”

“…Eight papers were found to have “good” study quality [ 30 , 31 , 37 , 38 , 39 , 42 , 45 , 46 ]. Seven papers were found to have “very good” study quality [ 32 , 33 , 34 , 35 , 40 , 47 , 48 ].…”

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

“…This study was part of a larger study 50 that received ethics approval by the Human Research Ethics Committee of the University of Almeria (Spain). The intervention study was registered with ClinicalTrial.gov (NCT02642289; December 30, 2015).…”

Probiotics in digestive, emotional, and pain-related disorders

“…The design and performance of larger trials is urgently needed to verify whether these new strategies might be useful not only for the treatment of disorders affecting the GI tract but, importantly, also emotional and pain disorders not directly related to the GI tract. In this regard, we have recently described a protocol for the evaluation of the efficacy of probiotics in fibromyalgia (Roman et al, 2017). The future application of probiotics in the clinic should take into consideration important aspects.…”